A Phase 1 interventional study of Azelaic Acid 15% topical gel and Finacea® (azelaic acid) Gel, 15% in Rosacea, sponsored by Taro Pharmaceuticals USA. Completed. Open to participants aged 18 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2024-04-10.
Sponsored by Taro Pharmaceuticals USA (part of Sun Pharmaceutical Industries Limited) · Phase 1, Interventional, and Treatment
Among 12 studies testing azelaic acid in Rosacea — none open to participants now, none under way, none of them phase 3. azelaic acid · Rosacea.
Among the 12 studies testing azelaic acid in Rosacea, this one is the 3rd largest by enrollment, is the only one that started in 2016, is one of 2 in phase 1, and was the 10th registered.
233 studies on the registry are indexed under Rosacea; 23 are open to participants now.
This study's enrollment of 1,000 is above the median of 61 across 200 interventional studies indexed under Rosacea.
Browse Rosacea studies →None of the 12 studies testing azelaic acid in Rosacea is open now.
azelaic acid: first FDA approval 1995 (AZELEX). What it is approved for, and how studies give it, is on its page →
Of the 17 Rosacea studies recruiting now, 9 (53%) set no upper age limit and 7 (41%) stop at 75 or younger; 1 take children under 18; 8 take healthy volunteers.
This study: 18 Years and older · all sexes · healthy volunteers too.
The full table on the hub →12 studies; the count open now beside each. This study's row is marked.
First in 2007; this study’s year is marked. 1 started in 2016.
Median enrollment 77 across the 12 interventional studies. Of the 12 that completed or were terminated, 7 (58%) have results posted.
7 of 12 have an industry lead sponsor. The 9 most frequent:
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.
Taro Pharmaceuticals USA has 3 studies filed under Rosacea — fewer than ten, so there is no comparison to draw.
None of the studies under way reaches primary completion within a year.
Among the 12 studies testing azelaic acid in Rosacea, from their registry updates:
Nothing recorded among them since 2026-09-25.
A Multi-Center, Double-Blind, Randomized, Placebo Controlled, Parallel-Group Study
A Multi-Center, Double-Blind, Randomized, Placebo Controlled, Parallel-Group Study, comparing AZELAIC ACID TOPICAL GEL 15% TO FINACEA® and both active treatments to a Placebo Control in the treatment of Moderate of Facial Rosacea.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Topical, twice daily, for 84 days A thin layer of study treatment was gently massaged into the affected areas on the face
Drug: Azelaic Acid 15% topical gel
Topical, twice daily, for 84 days A thin layer of study treatment was gently massaged into the affected areas on the face
Drug: Finacea® (azelaic acid) Gel, 15%
Topically to the face, twice a day A thin layer of study treatment was gently massaged into the affected areas on the face
Drug: Placebo
Gel
Also known as: Azelaic Acid
Gel
Also known as: Azelaic Acid
Gel
Also known as: Vehicle
Change in inflammatory lesion counts
Percent change from baseline to Week 12 in the inflammatory (papules and pustules) lesion counts
Time frame: 12 weeks
No study locations are listed for this record.
Plan to share: No
No publications or documents are linked to this record.
This study is completed, as verified in Apr 2024. You cannot join it, but the record below documents what was studied.
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Studies of the drug tested here: Azelaic acid