A Phase 3 interventional study of Product 0405 and Placebo for Product 0405 in Atopic Dermatitis, sponsored by Fougera Pharmaceuticals Inc.. Withdrawn. Open to participants aged 3 Months to 17 Years. Per ClinicalTrials.gov, last updated 2014-06-27.
Sponsored by Fougera Pharmaceuticals Inc. · Phase 3, Interventional, and Treatment
The purpose of this study is to evaluate the safety and efficacy of product 0405 in pediatric subjects with Mild to Moderate Atopic Dermatitis.
Treatment medication will be administered topically twice daily for 28 days
1,444 studies on the registry are indexed under Dermatitis, Atopic; 253 are open to participants now.
Browse Dermatitis, Atopic studies →Fougera Pharmaceuticals Inc. is the lead sponsor of 12 studies on the registry; none are open to participants now.
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Exclusion Criteria:
Topical active investigational Product 0405
Drug: Product 0405
Topical Placebo for Product 0405
Drug: Placebo for Product 0405
Product 0405 will be administered topically twice daily for 28 days.
Placebo for Product 0405 will be administered topically twice daily for 28 days.
Statistically significant superiority of the test Product 0405 to the vehicle
Statistically significant superiority of the test Product 0405 to the vehicle
Time frame: 28 days
Incidence of success based on the Investigators Static Global Assessment and the Clinical Signs and Symptoms (erythema, scaling) at the end of treatment.
Incidence of success based on the Investigators Static Global Assessment and the Clinical Signs and Symptoms (erythema, scaling) at the end of treatment.
Time frame: 28 days
No study locations are listed for this record.
This study is withdrawn, as verified in Jun 2014. You cannot join it, but the record below documents what was studied.
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Fougera Pharmaceuticals Inc.