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A Multicenter, Randomized, Double-Blind, Four-Week, Bilateral Study of the Safety and Efficacy of Two Concentrations of AN2728 Ointment Administered Once or Twice a Day in Adolescents With Atopic Dermatitis
The purpose of this study is to determine the safety and efficacy of AN2728 Topical Ointment, 2% and 0.5%, administered once a day (QD) or twice a day (BID), in the treatment of adolescents with atopic dermatitis (AD)
Details
| Lead sponsor | Pfizer |
|---|---|
| Phase | Phase 2 |
| Status | COMPLETED |
| Enrolment | 86 |
| Start date | 2012-08 |
| Completion | 2013-01 |
Conditions
- Dermatitis, Atopic
Interventions
- AN2728 Topical Ointment, 2% QD
- AN2728 Topical Ointment, 0.5% QD
- AN2728 Topical Ointment, 2% BID
- AN2728 Topical Ointment, 0.5% BID
Primary outcomes
- Improvement From Baseline in Atopic Dermatitis Severity Index (ADSI) Score at Day 8 — Baseline, Day 8
ADSI was used to assess the severity of atopic dermatitis (AD) based on five subscale scores of erythema, pruritus, exudation, excoriation, and lichenification. The severity of each subscale was measured on a 4-point scale ranging from 0 (none) to 3 (severe), where higher scores indicating more severity. ADSI was calculated as the sum of these 5 subscale scores with a total possible score range of 0 (none) to 15 (most severe) where, higher scores indicating more severity. Improvement from Baseline was calculated as Baseline score minus follow-up score. - Improvement From Baseline in Atopic Dermatitis Severity Index (ADSI) Score at Day 15 — Baseline, Day 15
ADSI was used to assess the severity of atopic dermatitis (AD) based on five subscale scores of erythema, pruritus, exudation, excoriation, and lichenification. The severity of each subscale was measured on a 4-point scale ranging from 0 (none) to 3 (severe), where higher scores indicating more severity. ADSI was calculated as the sum of these 5 subscale scores with a total possible score range of 0 (none) to 15 (most severe) where, higher scores indicating more severity. Improvement from Baseline was calculated as Baseline score minus follow-up score. - Improvement From Baseline in Atopic Dermatitis Severity Index (ADSI) Score at Day 22 — Baseline, Day 22
ADSI was used to assess the severity of atopic dermatitis (AD) based on five subscale scores of erythema, pruritus, exudation, excoriation, and lichenification. The severity of each subscale was measured on a 4-point scale ranging from 0 (none) to 3 (severe), where higher scores indicating more severity. ADSI was calculated as the sum of these 5 subscale scores with a total possible score range of 0 (none) to 15 (most severe) where, higher scores indicating more severity. Improvement from Baseline was calculated as Baseline score minus follow-up score. - Improvement From Baseline in Atopic Dermatitis Severity Index (ADSI) Score at Day 29 — Baseline, Day 29
ADSI was used to assess the severity of atopic dermatitis (AD) based on five subscale scores of erythema, pruritus, exudation, excoriation, and lichenification. The severity of each subscale was measured on a 4-point scale ranging from 0 (none) to 3 (severe), where higher scores indicating more severity. ADSI was calculated as the sum of these 5 subscale scores with a total possible score range of 0 (none) to 15 (most severe) where, higher scores indicating more severity. Improvement from Baseline was calculated as Baseline score minus follow-up score.
Countries
United States, Australia