Phase 3 N=793 Randomized Quadruple-blind Treatment

Study of 0416 Ointment in the Treatment of Atopic Dermatitis

Atopic Dermatitis

Bottom Line

View on ClinicalTrials.gov: NCT01053247 ↗

Enrolled (actual)

793

Serious AEs

0.0%

Results posted

Oct 2014

Primary outcome: Primary: Incidence of Success Based on the Investigator's Global Evaluation at the End of Treatment — 104; 121; 67 participants

Study Design & Population

Study type: Interventional
Phase: Phase 3
Interventions: 0416 (Drug); Vehicle of 0416 test product (Drug); tacrolimus ointment 0.1% (Drug)
Age: Adult, Older Adult · 18+ yrs
Sex: All
Sponsor: Fougera Pharmaceuticals Inc.
Primary completion: Aug 2009

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).	—	—

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.

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

View full record on ClinicalTrials.gov →

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.