Phase 3
Completed N=793
Study of 0416 Ointment in the Treatment of Atopic Dermatitis
Source: ClinicalTrials.gov NCT01053247 ↗Enrolled (actual)
793
Serious AEs
0.0%
Results posted
Oct 2014
Primary outcomePrimary: Incidence of Success Based on the Investigator's Global Evaluation at the End of Treatment — 104; 121; 67 participants
Summary
The aim of this trial is to assess the efficacy of 0416 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 2 weeks.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Incidence of Success Based on the Investigator's Global Evaluation at the End of Treatment |
104; 121; 67 | — |
| SECONDARY The Mean Change From Baseline in the Total Individual Clinical Signs and Symptoms Per Body Region, the Mean Change From Baseline in Pruritus and 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 (NCT01053247). 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.