A Phase 1 interventional study of Azelaic acid foam 15% and Finacea® (Azelaic acid Foam) 15% in Rosacea, sponsored by Taro Pharmaceuticals USA. Completed at 1 site in United States. Open to participants aged 18 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2019-03-19.
Sponsored by Taro Pharmaceuticals USA · Phase 1, Interventional, and Treatment
To demonstrate the superiority of the efficacy of the test and reference products over that of the placebo control in the treatment of moderate facial rosacea.
A Multi-Center, Double-Blind, Randomized, Placebo Controlled, Parallel-Group study, comparing test and reference products and both active treatments to a placebo control in the treatment of Moderate Facial Rosacea.
225 studies on the registry are indexed under Rosacea; 19 are open to participants now.
This study's enrollment of 1,116 is above the median of 61 across 195 interventional studies indexed under Rosacea.
Browse Rosacea studies →Taro Pharmaceuticals USA is the lead sponsor of 71 studies on the registry; none are open to participants now.
Of its 19 completed or terminated interventional studies of FDA-regulated products, 1 (5%) have results posted.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
Topical, twice daily (Apply the foam (morning and evening) to the entire facial area (cheeks, chin, forehead, and nose).
Drug: Azelaic acid foam 15%
Topical, twice daily (Apply the foam (morning and evening) to the entire facial area (cheeks, chin, forehead, and nose).
Drug: Finacea® (Azelaic acid Foam) 15%
Topical, twice daily (Apply the foam (morning and evening) to the entire facial area (cheeks, chin, forehead, and nose).
Drug: Vehicle of the test product
Azelaic acid foam 15%
Also known as: AZAF 1703
Azelaic acid foam 15%
Vehicle of the test product
Also known as: Placebo
change in the inflammatory lesion counts
Percent change from baseline to Week 12 in the inflammatory (papules and pustules) lesion counts
Time frame: 12 weeks
Plan to share: No
No publications or documents are linked to this record.
This study is completed, as verified in Mar 2019. You cannot join it, but the record below documents what was studied.
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Taro Pharmaceuticals USA