ID

22438

Beskrivning

ODM derived from http://clinicaltrials.gov/ct2/show/record/NCT01428297

Länk

http://clinicaltrials.gov/ct2/show/record/NCT01428297

Nyckelord

Versioner (2)
  1. 2011-11-25 2011-11-25 -
  2. 2017-06-04 2017-06-04 - Martin Dugas
Uppladdad den

4 juni 2017

DOI

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Creative Commons BY 4.0
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A Study Evaluating the Safety and Efficacy of Topical BPR277 for the Treatment of Atopic Dermatitis and Netherton Syndrome

Engelsk
Detaljer

Eligibility

1 Formulär  
  1. StudyEvent: Eligibility
    1. Eligibility
Inclusion Criteria Healthy volunteers
Healthy male and female subjects of non childbearing potential, 18 to 65 years of age inclusive and in good health
Inclusion Criteria Patients with atopic dermatitis
Male and female subjects, 18 to 65 years of age inclusive and having passed screening examinations
Presence of atopic dermatitis confirmed by Itchy skin condition in the past 12 months (must have) Plus three or more of the following: 1. History of involvement of the skin creases 2. Personal history of asthma or hay fever 3. History of generally dry skin in the past year 4. Onset before age of 2 years 5. Visible flexural dermatitis
Diagnosis of at least moderate atopic dermatitis by the IGA and a minimum target area (right or left) situated on the forearm including the antecubital fossa with a corresponding baseline total lesional sign score (TLSS)
Inclusion Criteria Patients with Netherton Syndrome
Patients with Netherton syndrome, male and female subjects, 18 to 65 years of age inclusive and having passed screening examinations
Confirmed diagnosis of Netherton syndrome (SPINK5 mutation or LEKTI deficiency in the skin)
Minimum total lesional sign score NS (TLSS-NS) of 5-9 for two selected target areas at baseline. The TLSS-NS values need to be similar between the two areas at baseline
Exclusion Criteria Healthy volunteers
History of hypersensitivity to any of the study drugs or to drugs of similar chemical classes or history of serious allergic reaction.
Use of any prescription drugs, herbal supplements, within four (4) weeks prior to initial dosing, and/or over-the-counter (OTC) medication, dietary supplements (vitamins included) within two (2) weeks prior to initial dosing
Exclusion Criteria Patients with atopic dermatitis
History of hypersensitivity to any of the study drugs or to drugs of similar chemical classes or history of serious allergic reaction.
History of abnormal skin reactivity to UV light. Unusual exposure to UV light in the previous 3 weeks to study start (screening), including tanning and sun beds
Pregnant or nursing (lactating) women
Women of child-bearing potential must use highly effective contraception (as further defined in study protocol)
Use of topical prescription treatment for eczema within 1 week prior to initial dosing of topical corticosteroids (TCS).
Recent previous treatment with systemic treatment including phototherapy. A washout period will be required for such patients to be eligible to participate in the trial.
Exclusion Criteria Patients with Netherton Syndrome
History of hypersensitivity to any of the study drugs or to drugs of similar chemical classes or history of serious allergic reaction
History of abnormal skin reactivity to UV light. Unusual exposure to UV light in the previous 3 weeks to study start (screening), including tanning and sun beds
Pregnant or nursing (lactating) women
Women of child-bearing potential must use highly effective contraception (as further defined in study protocol)
Use of topical prescription treatment within 2 week prior to initial dosing of study drug
Recent previous treatment with systemic treatment. A washout period will be required for such patients to be eligible to participate in the trial.
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