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Study of 0416 Ointment in the Treatment of Atopic Dermatitis

NCT01053247 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 793

Last updated 2014-10-03

Study results available
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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.

Conditions

Interventions

DRUG

0416

Topical 0416 test product applied twice daily for 2 weeks

DRUG

Vehicle of 0416 test product

Vehicle of 0416 test product applied twice daily for 2 weeks

DRUG

tacrolimus ointment 0.1%

Reference Product for 0416 test product. Apply twice daily for 2 weeks.

Sponsors & Collaborators

  • Fougera Pharmaceuticals Inc.

    lead INDUSTRY

Principal Investigators

  • Angela C Kaplan · Fougera Pharmaceuticals Inc.

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2008-01-31
Primary Completion
2009-08-31
Completion
2009-08-31

Countries

  • United States

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01053247 on ClinicalTrials.gov