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

Yes

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)

Yes

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

Yes

Confirmed diagnosis of Netherton syndrome (SPINK5 mutation or LEKTI deficiency in the skin)

Yes

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

Yes

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.

Yes

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

Yes

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.

Yes

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

Yes

Pregnant or nursing (lactating) women

Yes

Women of child-bearing potential must use highly effective contraception (as further defined in study protocol)

Yes

Use of topical prescription treatment for eczema within 1 week prior to initial dosing of topical corticosteroids (TCS).

Yes

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.

Yes

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

Yes

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

Yes

Pregnant or nursing (lactating) women

Yes

Women of child-bearing potential must use highly effective contraception (as further defined in study protocol)

Yes

Use of topical prescription treatment within 2 week prior to initial dosing of study drug

Yes

Recent previous treatment with systemic treatment. A washout period will be required for such patients to be eligible to participate in the trial.

Yes

Ritorna all'inizio della pagina

Similar models

Show recommended models

Descrizione:

collegamento:

Keywords:

versioni (2)

Caricato su:

DOI:

Licenza :

Commenti del modello :

Commenti del gruppo di articoli per :

Commenti dell'articolo per :

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

Eligibility

Similar models

Contatto

Aiuto