Phase 3
Completed N=899
Study of 0417 Ointment in the Treatment of Atopic Dermatitis
Source: ClinicalTrials.gov NCT01139450 ↗Enrolled (actual)
899
Serious AEs
0.2%
Results posted
Sep 2014
Primary outcomePrimary: Incidence of Success Based on the Investigator's Global Evaluation at the End of Treatment — 123; 130; 86 participants
Summary
The aim of this trial is to assess the efficacy of 0417 Ointment in the Treatment of Atopic Dermatitis.
Treatment medication will be administered as follows: Apply a thin layer of ointment to affected skin areas twice daily and rub in gently and completely. Study medication will be applied twice a day, approximately 12 hours apart, for approximately 4 weeks.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Incidence of Success Based on the Investigator's Global Evaluation at the End of Treatment |
123; 130; 86 | — |
| SECONDARY The Mean Change From Baseline in the Total Individual Clinical Signs and Symptoms Per Body Region |
— | — |
| SECONDARY The Mean Change From Baseline in Pruritus |
— | — |
| SECONDARY The Mean Change From Baseline in the Percentage Total Body Surface Affected (%BSA) |
— | — |
Eligibility Criteria
Inclusion Criteria
- Clinical diagnosis of Atopic Dermatitis
- Good health with the exception of Atopic Dermatitis
- Percent Body Surface Area minimum requirements
Exclusion Criteria
- Subjects who are pregnant, nursing, or planning a pregnancy within the study participation period.
- Subjects who have any systemic or dermatological disorders with the exception of Atopic Dermatitis
Data sourced from ClinicalTrials.gov (NCT01139450). 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.