Phase 2
Completed N=46
Efficacy and Safety of AN2898 and AN2728 Topical Ointments to Treat Mild-to-Moderate Atopic Dermatitis
Dermatitis, Atopic
Source: ClinicalTrials.gov NCT01301508 ↗
Enrolled (actual)
46
Serious AEs
0.0%
Results posted
Mar 2017
Primary outcomePrimary: Atopic Dermatitis Severity Index (ADSI) Score at Baseline (Day 1) — 8.0; 8.3; 8.0; 8.4 units on a scale
Summary
The purpose of this study is to determine whether AN2898 and AN2728 ointments are safe and effective treatments for mild-to-moderate atopic dermatitis (AD).
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Atopic Dermatitis Severity Index (ADSI) Score at Baseline (Day 1) |
8.0; 8.3; 8.0; 8.4 | — |
| PRIMARY Atopic Dermatitis Severity Index (ADSI) Score at Day 14 |
3.8; 4.0; 5.4; 5.6 | — |
| PRIMARY Atopic Dermatitis Severity Index (ADSI) Score at Day 28 |
2.6; 2.8; 4.3; 5.1 | — |
| PRIMARY Atopic Dermatitis Severity Index (ADSI) Score at Day 42 |
3.5; 3.0; 3.1; 4.6 | — |
| PRIMARY Percentage of Participants With Decrease From Baseline in Atopic Dermatitis Severity Index (ADSI) Score at Day 28 |
71.4; 68.0; 14.3; 20.0 | 0.008 sig |
Eligibility Criteria
Inclusion Criteria
- Clinical diagnosis of atopic dermatitis that has been clinically stable for ≥1 month
- Total body surface area (BSA) of atopic dermatitis involvement ≤35%, excluding involvement of the face, scalp, and groin
- Presence of two (2) comparable target lesions
- Willing and able to apply study medications as directed, comply with study instructions, and commit to attending all visits
- Females of childbearing potential must use at least one highly effective method of birth control. Males with partners of childbearing potential should inform them of their participation in this clinical study and use highly effective methods of birth control during the study.
Exclusion Criteria
- Concurrent or recent use of certain topical or systemic medications or phototherapy without a sufficient washout period
- Active or potentially recurrent dermatologic condition other than atopic dermatitis in the target lesion area that may confound evaluation
- Significant confounding conditions as assessed by study doctor
- History or evidence of allergies requiring acute or chronic treatment (except seasonal allergic rhinitis)
- Participated in any other trial of an investigational drug or device within 30 days or participation in a research study concurrent with this study
- Pregnancy or lactation
Data sourced from ClinicalTrials.gov (NCT01301508). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.