ID

4269

Descrizione

ODM derived from http://clinicaltrials.gov/show/NCT00757523

collegamento

http://clinicaltrials.gov/show/NCT00757523

Keywords

versioni (3)
  1. 06/12/13 06/12/13 - Martin Dugas
  2. 16/04/14 16/04/14 - Julian Varghese
  3. 20/09/21 20/09/21 -
Caricato su

6 dicembre 2013

DOI

Per favore, per richiedere un accesso.

Licenza

Creative Commons BY-NC 3.0 Legacy
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Eligibility NCT00757523 Acne Vulgaris

Tedesco Inglese

Eligibility

1 moduli  
  1. StudyEvent: Eligibility
    1. Eligibility
Einschlusskriterien
Descrizione

Einschlusskriterien

Alias
UMLS CUI 2011AA
CL425202
Alter 12 bis 45 Jahre
Descrizione

age 12 Years to 45 Years

Tipo di dati

boolean

Alias
UMLS CUI 2011AA
C0001779
SNOMED CT 2011_0131
397669002
Males or females 12 to 45 years of age, inclusive, in good general health.
Descrizione

Males or females 12 to 45 years of age, inclusive, in good general health.

Tipo di dati

boolean

Alias
UMLS CUI 2011AA
C0015780
SNOMED CT 2011_0131
248152002
HL7 V3 2006_05
F
UMLS CUI 2011AA
C0024554
SNOMED CT 2011_0131
248153007
HL7 V3 2006_05
M
UMLS CUI 2011AA
C0031206
SNOMED CT 2011_0131
405153007
Clinical diagnosis of acne vulgaris
Descrizione

Clinical diagnosis of acne vulgaris

Tipo di dati

boolean

Alias
UMLS CUI 2011AA
C0332140
SNOMED CT 2011_0131
39154008
UMLS CUI 2011AA
C0001144
SNOMED CT 2011_0131
88616000
MedDRA 14.1
10000519
ICD-10-CM Version 2010
L70.0
Capable of understanding and willing to provide signed and dated written voluntary informed consent
Descrizione

Capable of understanding and willing to provide signed and dated written voluntary informed consent

Tipo di dati

boolean

Alias
UMLS CUI 2011AA
C1273101
SNOMED CT 2011_0131
395659009
UMLS CUI 2011AA
C0600109
SNOMED CT 2011_0131
225466006
UMLS CUI 2011AA
C0184704
SNOMED CT 2011_0131
55149002
Female subjects of childbearing potential must have a negative pregnancy test at baseline. Sexually active women of childbearing potential participating in the study must use a medically acceptable form of contraception
Descrizione

Female subjects of childbearing potential must have a negative pregnancy test at baseline. Sexually active women of childbearing potential participating in the study must use a medically acceptable form of contraception

Tipo di dati

boolean

Alias
UMLS CUI 2011AA
C0015780
SNOMED CT 2011_0131
248152002
HL7 V3 2006_05
F
UMLS CUI 2011AA
C1148523
UMLS CUI 2011AA
C0237399
UMLS CUI 2011AA
C0427780
SNOMED CT 2011_0131
250425007
MedDRA 14.1
10036574
UMLS CUI 2011AA
C1442488
UMLS CUI 2011AA
C0241028
SNOMED CT 2011_0131
228453005
MedDRA 14.1
10066098
UMLS CUI 2011AA
C0043210
SNOMED CT 2011_0131
224526002
UMLS CUI 2011AA
C0700589
SNOMED CT 2011_0131
146680009
MedDRA 14.1
10010808
Subjects who have been treated with estrogens, androgens, or anti-androgenic agents for more than 12 consecutive weeks prior to the first dose of study product are allowed to enroll as long as they do not expect to change dose, drug, or discontinue use during the study.
Descrizione

Subjects who have been treated with estrogens, androgens, or anti-androgenic agents for more than 12 consecutive weeks prior to the first dose of study product are allowed to enroll as long as they do not expect to change dose, drug, or discontinue use during the study.

Tipo di dati

boolean

Alias
UMLS CUI 2011AA
CL415147
UMLS CUI 2011AA
C0014939
SNOMED CT 2011_0131
41598000, 61946003
LOINC Version 232
MTHU003480
UMLS CUI 2011AA
C0002844
SNOMED CT 2011_0131
66349002
UMLS CUI 2011AA
C0002842
SNOMED CT 2011_0131
346324007
UMLS CUI 2011AA
C0332152
SNOMED CT 2011_0131
288556008
UMLS CUI 2011AA
C0178602
SNOMED CT 2011_0131
260911001
UMLS CUI 2011AA
C0304229
SNOMED CT 2011_0131
902003
UMLS CUI 2011AA
C1524004
UMLS CUI 2011AA
C1516879
The ability and willingness to follow all study procedures, attend all scheduled visits, and successfully complete the study.
Descrizione

The ability and willingness to follow all study procedures, attend all scheduled visits, and successfully complete the study.

Tipo di dati

boolean

Alias
UMLS CUI 2011AA
C0085732
SNOMED CT 2011_0131
371150009
UMLS CUI 2011AA
C0600109
SNOMED CT 2011_0131
225466006
UMLS CUI 2011AA
C1321605
SNOMED CT 2011_0131
405078008
UMLS CUI 2011AA
C0680734
UMLS CUI 2011AA
C1554196
HL7 V3 2006_05
ENC
UMLS CUI 2011AA
C1554962
HL7 V3 2006_05
C
UMLS CUI 2011AA
C0008976
SNOMED CT 2011_0131
110465008
Ausschlusskriterien
Descrizione

Ausschlusskriterien

Alias
UMLS CUI 2011AA
CL425201
Female subjects who are pregnant, trying to become pregnant, or who are lactating.
Descrizione

Female subjects who are pregnant, trying to become pregnant, or who are lactating.

Tipo di dati

boolean

Alias
UMLS CUI 2011AA
C0015780
SNOMED CT 2011_0131
248152002
HL7 V3 2006_05
F
UMLS CUI 2011AA
C0549206
MedDRA 14.1
10036586
UMLS CUI 2011AA
C2828358
UMLS CUI 2011AA
C0032992
SNOMED CT 2011_0131
169565003
Any clinically relevant finding at their baseline physical examination or medical history such as severe systemic diseases or diseases of the facial skin other than acne vulgaris.
Descrizione

Any clinically relevant finding at their baseline physical examination or medical history such as severe systemic diseases or diseases of the facial skin other than acne vulgaris.

Tipo di dati

boolean

Alias
UMLS CUI 2011AA
C1442488
UMLS CUI 2011AA
C0031809
SNOMED CT 2011_0131
5880005
MedDRA 14.1
10034986
LOINC Version 232
MTHU028014
ICD-9-CM Version 2011
89.7
UMLS CUI 2011AA
CL421546
SNOMED CT 2011_0131
392521001
UMLS CUI 2011AA
C0442893
SNOMED CT 2011_0131
56019007, 264578000
UMLS CUI 2011AA
C0012634
SNOMED CT 2011_0131
64572001
UMLS CUI 2011AA
C0222084
SNOMED CT 2011_0131
73897004
UMLS CUI 2011AA
CL411789
UMLS CUI 2011AA
C0001144
SNOMED CT 2011_0131
88616000
MedDRA 14.1
10000519
ICD-10-CM Version 2010
L70.0
Facial hair that may obscure the accurate assessment of acne grade.
Descrizione

Facial hair that may obscure the accurate assessment of acne grade.

Tipo di dati

boolean

Alias
UMLS CUI 2011AA
C0221980
SNOMED CT 2011_0131
62961004
UMLS CUI 2011AA
C0521102
SNOMED CT 2011_0131
78235001
UMLS CUI 2011AA
C0582103
SNOMED CT 2011_0131
225886003
UMLS CUI 2011AA
C0001144
SNOMED CT 2011_0131
88616000
MedDRA 14.1
10000519
ICD-10-CM Version 2010
L70.0
UMLS CUI 2011AA
C0441800
SNOMED CT 2011_0131
258349007
LOINC Version 232
MTHU003112
History or presence of regional enteritis or inflammatory bowel disease (eg, ulcerative colitis, pseudomembranous colitis, chronic diarrhea, or a history of antibiotic-associated colitis) or similar symptoms.
Descrizione

History or presence of regional enteritis or inflammatory bowel disease (eg, ulcerative colitis, pseudomembranous colitis, chronic diarrhea, or a history of antibiotic-associated colitis) or similar symptoms.

Tipo di dati

boolean

Alias
UMLS CUI 2011AA
C0678202
MedDRA 14.1
10038280
ICD-10-CM Version 2010
K50.90
ICD-9-CM Version 2011
555
UMLS CUI 2011AA
C0021390
SNOMED CT 2011_0131
24526004
MedDRA 14.1
10021972
UMLS CUI 2011AA
C0302596
SNOMED CT 2011_0131
64766004
MedDRA 14.1
10009900
ICD-10-CM Version 2010
K51
ICD-9-CM Version 2011
556
UMLS CUI 2011AA
C1257843
SNOMED CT 2011_0131
397683000
MedDRA 14.1
10037128
ICD-10-CM Version 2010
A04.7
UMLS CUI 2011AA
C0401151
SNOMED CT 2011_0131
236071009
MedDRA 14.1
10066556
UMLS CUI 2011AA
CL421546
SNOMED CT 2011_0131
392521001
UMLS CUI 2011AA
C0085819
SNOMED CT 2011_0131
397696004
MedDRA 14.1
10052815
Used topical antibiotics on the face or systemic antibiotics within the past 2 and 4 weeks, respectively.
Descrizione

Used topical antibiotics on the face or systemic antibiotics within the past 2 and 4 weeks, respectively.

Tipo di dati

boolean

Alias
UMLS CUI 2011AA
C1522168
SNOMED CT 2011_0131
6064005
HL7 V3 2006_05
TOPICAL
UMLS CUI 2011AA
C0003232
SNOMED CT 2011_0131
255631004
UMLS CUI 2011AA
C0015450
SNOMED CT 2011_0131
89545001
LOINC Version 232
MTHU003030
UMLS CUI 2011AA
C0205373
SNOMED CT 2011_0131
31099001
UMLS CUI 2011AA
C0003232
SNOMED CT 2011_0131
255631004
UMLS CUI 2011AA
C0439230
SNOMED CT 2011_0131
258705008
HL7 V3 2006_05
WK
Used topical corticosteroids on the face or systemic corticosteroids within the past 4 weeks. Use of inhaled, intra articular or intra-lesional (other than for facial acne lesions) steroids is acceptable.
Descrizione

Used topical corticosteroids on the face or systemic corticosteroids within the past 4 weeks. Use of inhaled, intra articular or intra-lesional (other than for facial acne lesions) steroids is acceptable.

Tipo di dati

boolean

Alias
UMLS CUI 2011AA
C0304604
SNOMED CT 2011_0131
331645009
UMLS CUI 2011AA
C0015450
SNOMED CT 2011_0131
89545001
LOINC Version 232
MTHU003030
UMLS CUI 2011AA
C0205373
SNOMED CT 2011_0131
31099001
UMLS CUI 2011AA
C0001617
SNOMED CT 2011_0131
79440004
UMLS CUI 2011AA
C0439230
SNOMED CT 2011_0131
258705008
HL7 V3 2006_05
WK
Used systemic retinoids within the past 6 months.
Descrizione

Used systemic retinoids within the past 6 months.

Tipo di dati

boolean

Alias
UMLS CUI 2011AA
C0205373
SNOMED CT 2011_0131
31099001
UMLS CUI 2011AA
C2267033
UMLS CUI 2011AA
C0439231
SNOMED CT 2011_0131
258706009
HL7 V3 2006_05
MO
Using drugs known to be photosensitizers (eg, thiazides, tetracyclines, fluoroquinolones, phenothiazines, sulfonamides) because of the possibility of increased phototoxicity.
Descrizione

Using drugs known to be photosensitizers (eg, thiazides, tetracyclines, fluoroquinolones, phenothiazines, sulfonamides) because of the possibility of increased phototoxicity.

Tipo di dati

boolean

Alias
UMLS CUI 2011AA
C0162713
SNOMED CT 2011_0131
108817007
UMLS CUI 2011AA
C0541746
LOINC Version 232
MTHU003336
UMLS CUI 2011AA
C0039644
SNOMED CT 2011_0131
66261008
LOINC Version 232
MTHU008490
UMLS CUI 2011AA
C0949665
UMLS CUI 2011AA
C0031436
SNOMED CT 2011_0131
372839006
UMLS CUI 2011AA
C0038760
SNOMED CT 2011_0131
387406002
LOINC Version 232
MTHU007722
UMLS CUI 2011AA
CL420107
UMLS CUI 2011AA
C0023693
SNOMED CT 2011_0131
56242006
UMLS CUI 2011AA
C0040539
Using neuromuscular blocking agents. Clindamycin has neuromuscular blocking activities, which may enhance the action of other neuromuscular blocking agents.
Descrizione

Using neuromuscular blocking agents. Clindamycin has neuromuscular blocking activities, which may enhance the action of other neuromuscular blocking agents.

Tipo di dati

boolean

Alias
UMLS CUI 2011AA
C0027866
SNOMED CT 2011_0131
87586001
UMLS CUI 2011AA
C0008947
SNOMED CT 2011_0131
58883005
LOINC Version 232
MTHU006899
Used topical anti-acne medications (eg, BPO, retinoids, azelaic acid, resorcinol, salicylates, sulfacetamide sodium and derivatives, glycolic acid) within the past 2 weeks.
Descrizione

Used topical anti-acne medications (eg, BPO, retinoids, azelaic acid, resorcinol, salicylates, sulfacetamide sodium and derivatives, glycolic acid) within the past 2 weeks.

Tipo di dati

boolean

Alias
UMLS CUI 2011AA
C0360289
SNOMED CT 2011_0131
350088003
UMLS CUI 2011AA
C0521124
SNOMED CT 2011_0131
65897001
UMLS CUI 2011AA
C0001144
SNOMED CT 2011_0131
88616000
MedDRA 14.1
10000519
ICD-10-CM Version 2010
L70.0
UMLS CUI 2011AA
C0005088
SNOMED CT 2011_0131
354053005
UMLS CUI 2011AA
C2267033
UMLS CUI 2011AA
C0052761
SNOMED CT 2011_0131
108908008
UMLS CUI 2011AA
C0073085
SNOMED CT 2011_0131
411296008
UMLS CUI 2011AA
C0036075
SNOMED CT 2011_0131
255637000
UMLS CUI 2011AA
C0282356
SNOMED CT 2011_0131
108867000
UMLS CUI 2011AA
C0243072
UMLS CUI 2011AA
C0220840
SNOMED CT 2011_0131
115383003
LOINC Version 232
MTHU009348
UMLS CUI 2011AA
C0439230
SNOMED CT 2011_0131
258705008
HL7 V3 2006_05
WK
Used any investigational therapy within 4 weeks of study day 1.
Descrizione

Used any investigational therapy within 4 weeks of study day 1.

Tipo di dati

boolean

Alias
UMLS CUI 2011AA
C0949266
UMLS CUI 2011AA
C0332285
SNOMED CT 2011_0131
18720000
UMLS CUI 2011AA
C0205450
SNOMED CT 2011_0131
9362000
UMLS CUI 2011AA
C0439230
SNOMED CT 2011_0131
258705008
HL7 V3 2006_05
WK
UMLS CUI 2011AA
C2348558
Using the following types of facial products: astringents, toners, abradants, facials, peels containing glycolic or other acids, masks, washes or soaps containing BPO, sulfacetamide sodium or salicylic acid, non-mild facial cleansers, or moisturizers that contain retinol, salicylic acid, or alpha- or beta-hydroxy acids.
Descrizione

Using the following types of facial products: astringents, toners, abradants, facials, peels containing glycolic or other acids, masks, washes or soaps containing BPO, sulfacetamide sodium or salicylic acid, non-mild facial cleansers, or moisturizers that contain retinol, salicylic acid, or alpha- or beta-hydroxy acids.

Tipo di dati

boolean

Alias
UMLS CUI 2011AA
C0015450
SNOMED CT 2011_0131
89545001
LOINC Version 232
MTHU003030
UMLS CUI 2011AA
C1514468
UMLS CUI 2011AA
C0004110
SNOMED CT 2011_0131
60533005
UMLS CUI 2011AA
C0022585
SNOMED CT 2011_0131
373478008
UMLS CUI 2011AA
C0220840
SNOMED CT 2011_0131
115383003
LOINC Version 232
MTHU009348
UMLS CUI 2011AA
C0001128
SNOMED CT 2011_0131
34957004
UMLS CUI 2011AA
C0441648
UMLS CUI 2011AA
C0037392
SNOMED CT 2011_0131
25780000
UMLS CUI 2011AA
C0005088
SNOMED CT 2011_0131
354053005
UMLS CUI 2011AA
C0282356
SNOMED CT 2011_0131
108867000
UMLS CUI 2011AA
C0036079
SNOMED CT 2011_0131
387253001
UMLS CUI 2011AA
C0015450
SNOMED CT 2011_0131
89545001
LOINC Version 232
MTHU003030
UMLS CUI 2011AA
C0724557
UMLS CUI 2011AA
C0455079
SNOMED CT 2011_0131
225130001
UMLS CUI 2011AA
C0087161
SNOMED CT 2011_0131
82156005
UMLS CUI 2011AA
C0772110
UMLS CUI 2011AA
C0439096
SNOMED CT 2011_0131
260989008
UMLS CUI 2011AA
C0020317
Using medications that are reported to exacerbate acne (eg, mega-doses of certain vitamins such as vitamin D, vitamin A, and vitamins B2, B6, and B12, haloperidol, halogens such as iodide and bromide, lithium, hydantoin, and phenobarbital) as these may impact efficacy assessments
Descrizione

Using medications that are reported to exacerbate acne (eg, mega-doses of certain vitamins such as vitamin D, vitamin A, and vitamins B2, B6, and B12, haloperidol, halogens such as iodide and bromide, lithium, hydantoin, and phenobarbital) as these may impact efficacy assessments

Tipo di dati

boolean

Alias
UMLS CUI 2011AA
C0013227
UMLS CUI 2011AA
C1444749
SNOMED CT 2011_0131
410661009
UMLS CUI 2011AA
C0001144
SNOMED CT 2011_0131
88616000
MedDRA 14.1
10000519
ICD-10-CM Version 2010
L70.0
UMLS CUI 2011AA
C0444956
SNOMED CT 2011_0131
261829003
UMLS CUI 2011AA
C0042866
SNOMED CT 2011_0131
30178006
UMLS CUI 2011AA
C0042839
SNOMED CT 2011_0131
82622003
LOINC Version 232
MTHU005041
UMLS CUI 2011AA
C0373720
MedDRA 14.1
10058767
UMLS CUI 2011AA
C0087162
SNOMED CT 2011_0131
259662009
UMLS CUI 2011AA
C0042845
SNOMED CT 2011_0131
81064004
UMLS CUI 2011AA
C0018546
SNOMED CT 2011_0131
386837002
LOINC Version 232
MTHU005005
UMLS CUI 2011AA
C0018544
SNOMED CT 2011_0131
28227002
UMLS CUI 2011AA
C0021966
SNOMED CT 2011_0131
42146005
LOINC Version 232
MTHU020182
UMLS CUI 2011AA
C0006222
SNOMED CT 2011_0131
16624005
LOINC Version 232
MTHU005164
UMLS CUI 2011AA
C0023870
SNOMED CT 2011_0131
85899009
LOINC Version 232
MTHU004197
UMLS CUI 2011AA
C0020208
SNOMED CT 2011_0131
372659008
UMLS CUI 2011AA
C0031412
SNOMED CT 2011_0131
51073002
LOINC Version 232
MTHU003431
Have had a facial procedure (chemical or laser peel, microdermabrasion, artificial ultraviolet [UV] therapy) performed by an esthetician, beautician, physician, nurse, or other practitioner, within the past 4 weeks.
Descrizione

Have had a facial procedure (chemical or laser peel, microdermabrasion, artificial ultraviolet [UV] therapy) performed by an esthetician, beautician, physician, nurse, or other practitioner, within the past 4 weeks.

Tipo di dati

boolean

Alias
UMLS CUI 2011AA
C0015450
SNOMED CT 2011_0131
89545001
LOINC Version 232
MTHU003030
UMLS CUI 2011AA
C2700391
UMLS CUI 2011AA
C0191589
SNOMED CT 2011_0131
22132000
UMLS CUI 2011AA
C0023089
SNOMED CT 2011_0131
122456005
UMLS CUI 2011AA
C0191587
SNOMED CT 2011_0131
59601001
UMLS CUI 2011AA
C2004457
SNOMED CT 2011_0131
71967004
UMLS CUI 2011AA
C0041626
SNOMED CT 2011_0131
363695005
MedDRA 14.1
10046850
ICD-9-CM Version 2011
99.82
UMLS CUI 2011AA
C1444637
SNOMED CT 2011_0131
410513005
UMLS CUI 2011AA
C0205450
SNOMED CT 2011_0131
9362000
UMLS CUI 2011AA
C0439230
SNOMED CT 2011_0131
258705008
HL7 V3 2006_05
WK
Have a known hypersensitivity or previous allergic reaction to any of the active components, lincomycin, adapalene, clindamycin, BPO, or excipients of the study medication.
Descrizione

Have a known hypersensitivity or previous allergic reaction to any of the active components, lincomycin, adapalene, clindamycin, BPO, or excipients of the study medication.

Tipo di dati

boolean

Alias
UMLS CUI 2011AA
C0020517
SNOMED CT 2011_0131
418634005
ICD-10-CM Version 2010
T78.40
UMLS CUI 2011AA
C0023726
SNOMED CT 2011_0131
372677003
LOINC Version 232
MTHU008097
UMLS CUI 2011AA
C0165631
SNOMED CT 2011_0131
386934008
UMLS CUI 2011AA
C0008947
SNOMED CT 2011_0131
58883005
LOINC Version 232
MTHU006899
UMLS CUI 2011AA
C0005088
SNOMED CT 2011_0131
354053005
UMLS CUI 2011AA
C0015237
SNOMED CT 2011_0131
360215002
UMLS CUI 2011AA
C0304229
SNOMED CT 2011_0131
902003
Employees of a clinical research organization involved in the study, or Stiefel Laboratories, or an immediate family member (partner, offspring, parents, siblings, or sibling's offspring) of an employee.
Descrizione

Employees of a clinical research organization involved in the study, or Stiefel Laboratories, or an immediate family member (partner, offspring, parents, siblings, or sibling's offspring) of an employee.

Tipo di dati

boolean

Alias
UMLS CUI 2011AA
C0599987
SNOMED CT 2011_0131
224528001
UMLS CUI 2011AA
C0205210
SNOMED CT 2011_0131
58147004
UMLS CUI 2011AA
C0683939
UMLS CUI 2011AA
C1314939
SNOMED CT 2011_0131
248448006
UMLS CUI 2011AA
C0008976
SNOMED CT 2011_0131
110465008
UMLS CUI 2011AA
C0086282
SNOMED CT 2011_0131
303071001
HL7 V3 2006_05
FAMMEMB
Have a member of the same household in this trial.
Descrizione

Have a member of the same household in this trial.

Tipo di dati

boolean

Alias
UMLS CUI 2011AA
C0680022
SNOMED CT 2011_0131
394852005
UMLS CUI 2011AA
C0445247
SNOMED CT 2011_0131
262126009
UMLS CUI 2011AA
C0020052
UMLS CUI 2011AA
C0008976
SNOMED CT 2011_0131
110465008
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Similar models

Eligibility

1 moduli
  1. StudyEvent: Eligibility
    1. Eligibility
Name
genere
Description | Question | Decode (Coded Value)
Tipo di dati
Alias
Item Group
Einschlusskriterien
CL425202 (UMLS CUI 2011AA)
age 12 Years to 45 Years
Item
Alter 12 bis 45 Jahre
boolean
C0001779 (UMLS CUI 2011AA)
397669002 (SNOMED CT 2011_0131)
Males or females 12 to 45 years of age, inclusive, in good general health.
Item
Males or females 12 to 45 years of age, inclusive, in good general health.
boolean
C0015780 (UMLS CUI 2011AA)
248152002 (SNOMED CT 2011_0131)
F (HL7 V3 2006_05)
C0024554 (UMLS CUI 2011AA)
248153007 (SNOMED CT 2011_0131)
M (HL7 V3 2006_05)
C0031206 (UMLS CUI 2011AA)
405153007 (SNOMED CT 2011_0131)
Clinical diagnosis of acne vulgaris
Item
Clinical diagnosis of acne vulgaris
boolean
C0332140 (UMLS CUI 2011AA)
39154008 (SNOMED CT 2011_0131)
C0001144 (UMLS CUI 2011AA)
88616000 (SNOMED CT 2011_0131)
10000519 (MedDRA 14.1)
L70.0 (ICD-10-CM Version 2010)
Capable of understanding and willing to provide signed and dated written voluntary informed consent
Item
Capable of understanding and willing to provide signed and dated written voluntary informed consent
boolean
C1273101 (UMLS CUI 2011AA)
395659009 (SNOMED CT 2011_0131)
C0600109 (UMLS CUI 2011AA)
225466006 (SNOMED CT 2011_0131)
C0184704 (UMLS CUI 2011AA)
55149002 (SNOMED CT 2011_0131)
Female subjects of childbearing potential must have a negative pregnancy test at baseline. Sexually active women of childbearing potential participating in the study must use a medically acceptable form of contraception
Item
Female subjects of childbearing potential must have a negative pregnancy test at baseline. Sexually active women of childbearing potential participating in the study must use a medically acceptable form of contraception
boolean
C0015780 (UMLS CUI 2011AA)
248152002 (SNOMED CT 2011_0131)
F (HL7 V3 2006_05)
C1148523 (UMLS CUI 2011AA)
C0237399 (UMLS CUI 2011AA)
C0427780 (UMLS CUI 2011AA)
250425007 (SNOMED CT 2011_0131)
10036574 (MedDRA 14.1)
C1442488 (UMLS CUI 2011AA)
C0241028 (UMLS CUI 2011AA)
228453005 (SNOMED CT 2011_0131)
10066098 (MedDRA 14.1)
C0043210 (UMLS CUI 2011AA)
224526002 (SNOMED CT 2011_0131)
C0700589 (UMLS CUI 2011AA)
146680009 (SNOMED CT 2011_0131)
10010808 (MedDRA 14.1)
Subjects who have been treated with estrogens, androgens, or anti-androgenic agents for more than 12 consecutive weeks prior to the first dose of study product are allowed to enroll as long as they do not expect to change dose, drug, or discontinue use during the study.
Item
Subjects who have been treated with estrogens, androgens, or anti-androgenic agents for more than 12 consecutive weeks prior to the first dose of study product are allowed to enroll as long as they do not expect to change dose, drug, or discontinue use during the study.
boolean
CL415147 (UMLS CUI 2011AA)
C0014939 (UMLS CUI 2011AA)
41598000, 61946003 (SNOMED CT 2011_0131)
MTHU003480 (LOINC Version 232)
C0002844 (UMLS CUI 2011AA)
66349002 (SNOMED CT 2011_0131)
C0002842 (UMLS CUI 2011AA)
346324007 (SNOMED CT 2011_0131)
C0332152 (UMLS CUI 2011AA)
288556008 (SNOMED CT 2011_0131)
C0178602 (UMLS CUI 2011AA)
260911001 (SNOMED CT 2011_0131)
C0304229 (UMLS CUI 2011AA)
902003 (SNOMED CT 2011_0131)
C1524004 (UMLS CUI 2011AA)
C1516879 (UMLS CUI 2011AA)
The ability and willingness to follow all study procedures, attend all scheduled visits, and successfully complete the study.
Item
The ability and willingness to follow all study procedures, attend all scheduled visits, and successfully complete the study.
boolean
C0085732 (UMLS CUI 2011AA)
371150009 (SNOMED CT 2011_0131)
C0600109 (UMLS CUI 2011AA)
225466006 (SNOMED CT 2011_0131)
C1321605 (UMLS CUI 2011AA)
405078008 (SNOMED CT 2011_0131)
C0680734 (UMLS CUI 2011AA)
C1554196 (UMLS CUI 2011AA)
ENC (HL7 V3 2006_05)
C1554962 (UMLS CUI 2011AA)
C (HL7 V3 2006_05)
C0008976 (UMLS CUI 2011AA)
110465008 (SNOMED CT 2011_0131)
Item Group
Ausschlusskriterien
CL425201 (UMLS CUI 2011AA)
Female subjects who are pregnant, trying to become pregnant, or who are lactating.
Item
Female subjects who are pregnant, trying to become pregnant, or who are lactating.
boolean
C0015780 (UMLS CUI 2011AA)
248152002 (SNOMED CT 2011_0131)
F (HL7 V3 2006_05)
C0549206 (UMLS CUI 2011AA)
10036586 (MedDRA 14.1)
C2828358 (UMLS CUI 2011AA)
C0032992 (UMLS CUI 2011AA)
169565003 (SNOMED CT 2011_0131)
Any clinically relevant finding at their baseline physical examination or medical history such as severe systemic diseases or diseases of the facial skin other than acne vulgaris.
Item
Any clinically relevant finding at their baseline physical examination or medical history such as severe systemic diseases or diseases of the facial skin other than acne vulgaris.
boolean
C1442488 (UMLS CUI 2011AA)
C0031809 (UMLS CUI 2011AA)
5880005 (SNOMED CT 2011_0131)
10034986 (MedDRA 14.1)
MTHU028014 (LOINC Version 232)
89.7 (ICD-9-CM Version 2011)
CL421546 (UMLS CUI 2011AA)
392521001 (SNOMED CT 2011_0131)
C0442893 (UMLS CUI 2011AA)
56019007, 264578000 (SNOMED CT 2011_0131)
C0012634 (UMLS CUI 2011AA)
64572001 (SNOMED CT 2011_0131)
C0222084 (UMLS CUI 2011AA)
73897004 (SNOMED CT 2011_0131)
CL411789 (UMLS CUI 2011AA)
C0001144 (UMLS CUI 2011AA)
88616000 (SNOMED CT 2011_0131)
10000519 (MedDRA 14.1)
L70.0 (ICD-10-CM Version 2010)
Facial hair that may obscure the accurate assessment of acne grade.
Item
Facial hair that may obscure the accurate assessment of acne grade.
boolean
C0221980 (UMLS CUI 2011AA)
62961004 (SNOMED CT 2011_0131)
C0521102 (UMLS CUI 2011AA)
78235001 (SNOMED CT 2011_0131)
C0582103 (UMLS CUI 2011AA)
225886003 (SNOMED CT 2011_0131)
C0001144 (UMLS CUI 2011AA)
88616000 (SNOMED CT 2011_0131)
10000519 (MedDRA 14.1)
L70.0 (ICD-10-CM Version 2010)
C0441800 (UMLS CUI 2011AA)
258349007 (SNOMED CT 2011_0131)
MTHU003112 (LOINC Version 232)
History or presence of regional enteritis or inflammatory bowel disease (eg, ulcerative colitis, pseudomembranous colitis, chronic diarrhea, or a history of antibiotic-associated colitis) or similar symptoms.
Item
History or presence of regional enteritis or inflammatory bowel disease (eg, ulcerative colitis, pseudomembranous colitis, chronic diarrhea, or a history of antibiotic-associated colitis) or similar symptoms.
boolean
C0678202 (UMLS CUI 2011AA)
10038280 (MedDRA 14.1)
K50.90 (ICD-10-CM Version 2010)
555 (ICD-9-CM Version 2011)
C0021390 (UMLS CUI 2011AA)
24526004 (SNOMED CT 2011_0131)
10021972 (MedDRA 14.1)
C0302596 (UMLS CUI 2011AA)
64766004 (SNOMED CT 2011_0131)
10009900 (MedDRA 14.1)
K51 (ICD-10-CM Version 2010)
556 (ICD-9-CM Version 2011)
C1257843 (UMLS CUI 2011AA)
397683000 (SNOMED CT 2011_0131)
10037128 (MedDRA 14.1)
A04.7 (ICD-10-CM Version 2010)
C0401151 (UMLS CUI 2011AA)
236071009 (SNOMED CT 2011_0131)
10066556 (MedDRA 14.1)
CL421546 (UMLS CUI 2011AA)
392521001 (SNOMED CT 2011_0131)
C0085819 (UMLS CUI 2011AA)
397696004 (SNOMED CT 2011_0131)
10052815 (MedDRA 14.1)
Used topical antibiotics on the face or systemic antibiotics within the past 2 and 4 weeks, respectively.
Item
Used topical antibiotics on the face or systemic antibiotics within the past 2 and 4 weeks, respectively.
boolean
C1522168 (UMLS CUI 2011AA)
6064005 (SNOMED CT 2011_0131)
TOPICAL (HL7 V3 2006_05)
C0003232 (UMLS CUI 2011AA)
255631004 (SNOMED CT 2011_0131)
C0015450 (UMLS CUI 2011AA)
89545001 (SNOMED CT 2011_0131)
MTHU003030 (LOINC Version 232)
C0205373 (UMLS CUI 2011AA)
31099001 (SNOMED CT 2011_0131)
C0003232 (UMLS CUI 2011AA)
255631004 (SNOMED CT 2011_0131)
C0439230 (UMLS CUI 2011AA)
258705008 (SNOMED CT 2011_0131)
WK (HL7 V3 2006_05)
Used topical corticosteroids on the face or systemic corticosteroids within the past 4 weeks. Use of inhaled, intra articular or intra-lesional (other than for facial acne lesions) steroids is acceptable.
Item
Used topical corticosteroids on the face or systemic corticosteroids within the past 4 weeks. Use of inhaled, intra articular or intra-lesional (other than for facial acne lesions) steroids is acceptable.
boolean
C0304604 (UMLS CUI 2011AA)
331645009 (SNOMED CT 2011_0131)
C0015450 (UMLS CUI 2011AA)
89545001 (SNOMED CT 2011_0131)
MTHU003030 (LOINC Version 232)
C0205373 (UMLS CUI 2011AA)
31099001 (SNOMED CT 2011_0131)
C0001617 (UMLS CUI 2011AA)
79440004 (SNOMED CT 2011_0131)
C0439230 (UMLS CUI 2011AA)
258705008 (SNOMED CT 2011_0131)
WK (HL7 V3 2006_05)
Used systemic retinoids within the past 6 months.
Item
Used systemic retinoids within the past 6 months.
boolean
C0205373 (UMLS CUI 2011AA)
31099001 (SNOMED CT 2011_0131)
C2267033 (UMLS CUI 2011AA)
C0439231 (UMLS CUI 2011AA)
258706009 (SNOMED CT 2011_0131)
MO (HL7 V3 2006_05)
Using drugs known to be photosensitizers (eg, thiazides, tetracyclines, fluoroquinolones, phenothiazines, sulfonamides) because of the possibility of increased phototoxicity.
Item
Using drugs known to be photosensitizers (eg, thiazides, tetracyclines, fluoroquinolones, phenothiazines, sulfonamides) because of the possibility of increased phototoxicity.
boolean
C0162713 (UMLS CUI 2011AA)
108817007 (SNOMED CT 2011_0131)
C0541746 (UMLS CUI 2011AA)
MTHU003336 (LOINC Version 232)
C0039644 (UMLS CUI 2011AA)
66261008 (SNOMED CT 2011_0131)
MTHU008490 (LOINC Version 232)
C0949665 (UMLS CUI 2011AA)
C0031436 (UMLS CUI 2011AA)
372839006 (SNOMED CT 2011_0131)
C0038760 (UMLS CUI 2011AA)
387406002 (SNOMED CT 2011_0131)
MTHU007722 (LOINC Version 232)
CL420107 (UMLS CUI 2011AA)
C0023693 (UMLS CUI 2011AA)
56242006 (SNOMED CT 2011_0131)
C0040539 (UMLS CUI 2011AA)
Using neuromuscular blocking agents. Clindamycin has neuromuscular blocking activities, which may enhance the action of other neuromuscular blocking agents.
Item
Using neuromuscular blocking agents. Clindamycin has neuromuscular blocking activities, which may enhance the action of other neuromuscular blocking agents.
boolean
C0027866 (UMLS CUI 2011AA)
87586001 (SNOMED CT 2011_0131)
C0008947 (UMLS CUI 2011AA)
58883005 (SNOMED CT 2011_0131)
MTHU006899 (LOINC Version 232)
Used topical anti-acne medications (eg, BPO, retinoids, azelaic acid, resorcinol, salicylates, sulfacetamide sodium and derivatives, glycolic acid) within the past 2 weeks.
Item
Used topical anti-acne medications (eg, BPO, retinoids, azelaic acid, resorcinol, salicylates, sulfacetamide sodium and derivatives, glycolic acid) within the past 2 weeks.
boolean
C0360289 (UMLS CUI 2011AA)
350088003 (SNOMED CT 2011_0131)
C0521124 (UMLS CUI 2011AA)
65897001 (SNOMED CT 2011_0131)
C0001144 (UMLS CUI 2011AA)
88616000 (SNOMED CT 2011_0131)
10000519 (MedDRA 14.1)
L70.0 (ICD-10-CM Version 2010)
C0005088 (UMLS CUI 2011AA)
354053005 (SNOMED CT 2011_0131)
C2267033 (UMLS CUI 2011AA)
C0052761 (UMLS CUI 2011AA)
108908008 (SNOMED CT 2011_0131)
C0073085 (UMLS CUI 2011AA)
411296008 (SNOMED CT 2011_0131)
C0036075 (UMLS CUI 2011AA)
255637000 (SNOMED CT 2011_0131)
C0282356 (UMLS CUI 2011AA)
108867000 (SNOMED CT 2011_0131)
C0243072 (UMLS CUI 2011AA)
C0220840 (UMLS CUI 2011AA)
115383003 (SNOMED CT 2011_0131)
MTHU009348 (LOINC Version 232)
C0439230 (UMLS CUI 2011AA)
258705008 (SNOMED CT 2011_0131)
WK (HL7 V3 2006_05)
Used any investigational therapy within 4 weeks of study day 1.
Item
Used any investigational therapy within 4 weeks of study day 1.
boolean
C0949266 (UMLS CUI 2011AA)
C0332285 (UMLS CUI 2011AA)
18720000 (SNOMED CT 2011_0131)
C0205450 (UMLS CUI 2011AA)
9362000 (SNOMED CT 2011_0131)
C0439230 (UMLS CUI 2011AA)
258705008 (SNOMED CT 2011_0131)
WK (HL7 V3 2006_05)
C2348558 (UMLS CUI 2011AA)
Using the following types of facial products: astringents, toners, abradants, facials, peels containing glycolic or other acids, masks, washes or soaps containing BPO, sulfacetamide sodium or salicylic acid, non-mild facial cleansers, or moisturizers that contain retinol, salicylic acid, or alpha- or beta-hydroxy acids.
Item
Using the following types of facial products: astringents, toners, abradants, facials, peels containing glycolic or other acids, masks, washes or soaps containing BPO, sulfacetamide sodium or salicylic acid, non-mild facial cleansers, or moisturizers that contain retinol, salicylic acid, or alpha- or beta-hydroxy acids.
boolean
C0015450 (UMLS CUI 2011AA)
89545001 (SNOMED CT 2011_0131)
MTHU003030 (LOINC Version 232)
C1514468 (UMLS CUI 2011AA)
C0004110 (UMLS CUI 2011AA)
60533005 (SNOMED CT 2011_0131)
C0022585 (UMLS CUI 2011AA)
373478008 (SNOMED CT 2011_0131)
C0220840 (UMLS CUI 2011AA)
115383003 (SNOMED CT 2011_0131)
MTHU009348 (LOINC Version 232)
C0001128 (UMLS CUI 2011AA)
34957004 (SNOMED CT 2011_0131)
C0441648 (UMLS CUI 2011AA)
C0037392 (UMLS CUI 2011AA)
25780000 (SNOMED CT 2011_0131)
C0005088 (UMLS CUI 2011AA)
354053005 (SNOMED CT 2011_0131)
C0282356 (UMLS CUI 2011AA)
108867000 (SNOMED CT 2011_0131)
C0036079 (UMLS CUI 2011AA)
387253001 (SNOMED CT 2011_0131)
C0015450 (UMLS CUI 2011AA)
89545001 (SNOMED CT 2011_0131)
MTHU003030 (LOINC Version 232)
C0724557 (UMLS CUI 2011AA)
C0455079 (UMLS CUI 2011AA)
225130001 (SNOMED CT 2011_0131)
C0087161 (UMLS CUI 2011AA)
82156005 (SNOMED CT 2011_0131)
C0772110 (UMLS CUI 2011AA)
C0439096 (UMLS CUI 2011AA)
260989008 (SNOMED CT 2011_0131)
C0020317 (UMLS CUI 2011AA)
Using medications that are reported to exacerbate acne (eg, mega-doses of certain vitamins such as vitamin D, vitamin A, and vitamins B2, B6, and B12, haloperidol, halogens such as iodide and bromide, lithium, hydantoin, and phenobarbital) as these may impact efficacy assessments
Item
Using medications that are reported to exacerbate acne (eg, mega-doses of certain vitamins such as vitamin D, vitamin A, and vitamins B2, B6, and B12, haloperidol, halogens such as iodide and bromide, lithium, hydantoin, and phenobarbital) as these may impact efficacy assessments
boolean
C0013227 (UMLS CUI 2011AA)
C1444749 (UMLS CUI 2011AA)
410661009 (SNOMED CT 2011_0131)
C0001144 (UMLS CUI 2011AA)
88616000 (SNOMED CT 2011_0131)
10000519 (MedDRA 14.1)
L70.0 (ICD-10-CM Version 2010)
C0444956 (UMLS CUI 2011AA)
261829003 (SNOMED CT 2011_0131)
C0042866 (UMLS CUI 2011AA)
30178006 (SNOMED CT 2011_0131)
C0042839 (UMLS CUI 2011AA)
82622003 (SNOMED CT 2011_0131)
MTHU005041 (LOINC Version 232)
C0373720 (UMLS CUI 2011AA)
10058767 (MedDRA 14.1)
C0087162 (UMLS CUI 2011AA)
259662009 (SNOMED CT 2011_0131)
C0042845 (UMLS CUI 2011AA)
81064004 (SNOMED CT 2011_0131)
C0018546 (UMLS CUI 2011AA)
386837002 (SNOMED CT 2011_0131)
MTHU005005 (LOINC Version 232)
C0018544 (UMLS CUI 2011AA)
28227002 (SNOMED CT 2011_0131)
C0021966 (UMLS CUI 2011AA)
42146005 (SNOMED CT 2011_0131)
MTHU020182 (LOINC Version 232)
C0006222 (UMLS CUI 2011AA)
16624005 (SNOMED CT 2011_0131)
MTHU005164 (LOINC Version 232)
C0023870 (UMLS CUI 2011AA)
85899009 (SNOMED CT 2011_0131)
MTHU004197 (LOINC Version 232)
C0020208 (UMLS CUI 2011AA)
372659008 (SNOMED CT 2011_0131)
C0031412 (UMLS CUI 2011AA)
51073002 (SNOMED CT 2011_0131)
MTHU003431 (LOINC Version 232)
Have had a facial procedure (chemical or laser peel, microdermabrasion, artificial ultraviolet [UV] therapy) performed by an esthetician, beautician, physician, nurse, or other practitioner, within the past 4 weeks.
Item
Have had a facial procedure (chemical or laser peel, microdermabrasion, artificial ultraviolet [UV] therapy) performed by an esthetician, beautician, physician, nurse, or other practitioner, within the past 4 weeks.
boolean
C0015450 (UMLS CUI 2011AA)
89545001 (SNOMED CT 2011_0131)
MTHU003030 (LOINC Version 232)
C2700391 (UMLS CUI 2011AA)
C0191589 (UMLS CUI 2011AA)
22132000 (SNOMED CT 2011_0131)
C0023089 (UMLS CUI 2011AA)
122456005 (SNOMED CT 2011_0131)
C0191587 (UMLS CUI 2011AA)
59601001 (SNOMED CT 2011_0131)
C2004457 (UMLS CUI 2011AA)
71967004 (SNOMED CT 2011_0131)
C0041626 (UMLS CUI 2011AA)
363695005 (SNOMED CT 2011_0131)
10046850 (MedDRA 14.1)
99.82 (ICD-9-CM Version 2011)
C1444637 (UMLS CUI 2011AA)
410513005 (SNOMED CT 2011_0131)
C0205450 (UMLS CUI 2011AA)
9362000 (SNOMED CT 2011_0131)
C0439230 (UMLS CUI 2011AA)
258705008 (SNOMED CT 2011_0131)
WK (HL7 V3 2006_05)
Have a known hypersensitivity or previous allergic reaction to any of the active components, lincomycin, adapalene, clindamycin, BPO, or excipients of the study medication.
Item
Have a known hypersensitivity or previous allergic reaction to any of the active components, lincomycin, adapalene, clindamycin, BPO, or excipients of the study medication.
boolean
C0020517 (UMLS CUI 2011AA)
418634005 (SNOMED CT 2011_0131)
T78.40 (ICD-10-CM Version 2010)
C0023726 (UMLS CUI 2011AA)
372677003 (SNOMED CT 2011_0131)
MTHU008097 (LOINC Version 232)
C0165631 (UMLS CUI 2011AA)
386934008 (SNOMED CT 2011_0131)
C0008947 (UMLS CUI 2011AA)
58883005 (SNOMED CT 2011_0131)
MTHU006899 (LOINC Version 232)
C0005088 (UMLS CUI 2011AA)
354053005 (SNOMED CT 2011_0131)
C0015237 (UMLS CUI 2011AA)
360215002 (SNOMED CT 2011_0131)
C0304229 (UMLS CUI 2011AA)
902003 (SNOMED CT 2011_0131)
Employees of a clinical research organization involved in the study, or Stiefel Laboratories, or an immediate family member (partner, offspring, parents, siblings, or sibling's offspring) of an employee.
Item
Employees of a clinical research organization involved in the study, or Stiefel Laboratories, or an immediate family member (partner, offspring, parents, siblings, or sibling's offspring) of an employee.
boolean
C0599987 (UMLS CUI 2011AA)
224528001 (SNOMED CT 2011_0131)
C0205210 (UMLS CUI 2011AA)
58147004 (SNOMED CT 2011_0131)
C0683939 (UMLS CUI 2011AA)
C1314939 (UMLS CUI 2011AA)
248448006 (SNOMED CT 2011_0131)
C0008976 (UMLS CUI 2011AA)
110465008 (SNOMED CT 2011_0131)
C0086282 (UMLS CUI 2011AA)
303071001 (SNOMED CT 2011_0131)
FAMMEMB (HL7 V3 2006_05)
Have a member of the same household in this trial.
Item
Have a member of the same household in this trial.
boolean
C0680022 (UMLS CUI 2011AA)
394852005 (SNOMED CT 2011_0131)
C0445247 (UMLS CUI 2011AA)
262126009 (SNOMED CT 2011_0131)
C0020052 (UMLS CUI 2011AA)
C0008976 (UMLS CUI 2011AA)
110465008 (SNOMED CT 2011_0131)
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