To Study Generic Tacrolimus Ointment, 0.1% in the Treatment of Moderate to Severe Atopic Dermatitis (Inflammation of Skin: Itchy, Red, Swollen, and Cracked Skin)
Completed · Phase 3 · Has a placebo group
Conditions studied: Atopic Dermatitis
In brief
This is a Randomized, Double-Blind, Placebo-Controlled, Parallel-Group, Multiple-Site Study to Evaluate the Therapeutic Equivalence of a Generic Tacrolimus Ointment, 0.1% (Glenmark Pharmaceuticals, Ltd) to the Marketed Product Protopic® (tacrolimus) ointment, 0.1% (Astellas Pharma US, Inc.) in the Treatment of Moderate to Severe Atopic Dermatitis (AD).
Key facts
- Study ID
- NCT02601703
- Run by
- Glenmark Pharmaceuticals Ltd. India
- People needed
- 1110
- Starts
- 2015-08-01
- Expected to finish
- 2016-10-01
- Last updated by the study team
- 2019-07-31
Who can join
Age: 18 and older. Sex: any. Healthy volunteers: not accepted.
Where it is running
- Glenmark Investigational Site 31 — Anaheim, California, United States
- Glenmark Investigational Site 23 — Bell Gardens, California, United States
- Glenmark Investigational Site 30 — Cerritos, California, United States
- Glenmark Investigational Site 15 — Chula Vista, California, United States
- Glenmark Investigational Site 14 — La Mesa, California, United States
- Glenmark Investigational Site 1 — Long Beach, California, United States
- Glenmark Investigational Site 17 — Oceanside, California, United States
- Glenmark Investigational Site 25 — Pasadena, California, United States
- Glenmark Investigational Site 20 — San Ramon, California, United States
- Glenmark Investigational Site 44 — Santa Ana, California, United States
- Glenmark Investigational Site 45 — Brooksville, Florida, United States
- Glenmark Investigational Site 43 — Coral Gables, Florida, United States
- Glenmark Investigational Site 34 — Doral, Florida, United States
- Glenmark Investigational Site 22 — Fort Lauderdale, Florida, United States
- Glenmark Investigational Site 35 — Hialeah, Florida, United States
- Glenmark Investigational Site 59 — Hialeah Gardens, Florida, United States
- Glenmark Investigational Site 11 — Miami, Florida, United States
- Glenmark Investigational Site 19 — Miami, Florida, United States
- Glenmark Investigational Site 33 — Miami, Florida, United States
- Glenmark Investigational Site 40 — Miami, Florida, United States
- Glenmark Investigational Site 42 — Miami, Florida, United States
- Glenmark Investigational Site 50 — Miami, Florida, United States
- Glenmark Investigational Site 51 — Miami, Florida, United States
- Glenmark Investigational Site 54 — Miami, Florida, United States
- Glenmark Investigational Site 49 — Tempe, Arizona, United States
Full record on ClinicalTrials.gov
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