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)
Public ClinicalTrials.gov record NCT02601703. Field values are reproduced from the official study page; the official ClinicalTrials.gov record remains the source of truth for eligibility, enrollment, and contact information.
Data is sourced from official ClinicalTrials.gov public API records. Always review the official ClinicalTrials.gov record for the latest information.
Official title
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)
Study identification
- NCT ID
- NCT02601703
- Recruitment status
- Completed
- Study type
- Interventional
- Phase
- Phase 3
- Lead sponsor
- Glenmark Pharmaceuticals Ltd. India
- Industry
- Enrollment
- 1,110 participants
Conditions and interventions
Conditions
Interventions
- Placebo of Tacrolimus Ointment Drug
- Protopic® ointment, 0.1% Drug
- Tacrolimus Ointment 0.1% Drug
Drug
Eligibility (public fields only)
- Age range
- 18 Years and older
- Sex
- All
- Healthy volunteers
- Healthy volunteers not accepted
This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.
Study timeline
- Start date
- Jul 31, 2015
- Primary completion
- Sep 30, 2016
- Completion
- Sep 30, 2016
- Last update posted
- Jul 30, 2019
2015 – 2016
United States locations
- U.S. sites
- 60
- U.S. states
- 13
- U.S. cities
- 46
| Facility | City | State | ZIP | Site status |
|---|---|---|---|---|
| Glenmark Investigational Site 49 | Tempe | Arizona | — | — |
| Glenmark Investigational Site 31 | Anaheim | California | — | — |
| Glenmark Investigational Site 23 | Bell Gardens | California | — | — |
| Glenmark Investigational Site 30 | Cerritos | California | — | — |
| Glenmark Investigational Site 15 | Chula Vista | California | — | — |
| Glenmark Investigational Site 14 | La Mesa | California | — | — |
| Glenmark Investigational Site 1 | Long Beach | California | — | — |
| Glenmark Investigational Site 17 | Oceanside | California | — | — |
| Glenmark Investigational Site 25 | Pasadena | California | — | — |
| Glenmark Investigational Site 20 | San Ramon | California | — | — |
| Glenmark Investigational Site 44 | Santa Ana | California | — | — |
| Glenmark Investigational Site 45 | Brooksville | Florida | — | — |
| Glenmark Investigational Site 43 | Coral Gables | Florida | — | — |
| Glenmark Investigational Site 34 | Doral | Florida | — | — |
| Glenmark Investigational Site 22 | Fort Lauderdale | Florida | — | — |
| Glenmark Investigational Site 35 | Hialeah | Florida | — | — |
| Glenmark Investigational Site 59 | Hialeah Gardens | Florida | — | — |
| Glenmark Investigational Site 11 | Miami | Florida | — | — |
| Glenmark Investigational Site 19 | Miami | Florida | — | — |
| Glenmark Investigational Site 33 | Miami | Florida | — | — |
| Glenmark Investigational Site 40 | Miami | Florida | — | — |
| Glenmark Investigational Site 42 | Miami | Florida | — | — |
| Glenmark Investigational Site 50 | Miami | Florida | — | — |
| Glenmark Investigational Site 51 | Miami | Florida | — | — |
| Glenmark Investigational Site 54 | Miami | Florida | — | — |
| Glenmark Investigational Site 56 | Miami | Florida | — | — |
| Glenmark Investigational Site 58 | Miami | Florida | — | — |
| Glenmark Investigational Site7 | Miami | Florida | — | — |
| Glenmark Investigational Site 28 | Miami Gardens | Florida | — | — |
| Glenmark Investigational Site 29 | Miami Lakes | Florida | — | — |
| Glenmark Investigational Site 18 | Miramar | Florida | — | — |
| Glenmark Investigational Site 32 | North Miami Beach | Florida | — | — |
| Glenmark Investigational Site 48 | Orlando | Florida | — | — |
| Glenmark Investigational Site 4 | Ormond Beach | Florida | — | — |
| Glenmark Investigational Site 47 | Pembroke Pines | Florida | — | — |
| Glenmark Investigational Site 5 | Winter Park | Florida | — | — |
| Glenmark Investigational Site 52 | Macon | Georgia | — | — |
| Glenmark Investigational Site12 | Madisonville | Kentucky | — | — |
| Glenmark Investigational Site 2 | Saint Joseph | Missouri | — | — |
| Glenmark Investigational Site 41 | Henderson | Nevada | — | — |
| Glenmark Investigational Site 16 | Las Vegas | Nevada | — | — |
| Glenmark Investigational Site 9 | High Point | North Carolina | — | — |
| Glenmark Investigational Site 46 | Wilmington | North Carolina | — | — |
| Glenmark Investigational Site 53 | Cincinnati | Ohio | — | — |
| Glenmark Investigational Site 21 | Cleveland | Ohio | — | — |
| Glenmark Investigational Site 36 | Toledo | Ohio | — | — |
| Glenmark Investigational Site 3 | Hazleton | Pennsylvania | — | — |
| Glenmark Investigational Site 57 | West Columbia | South Carolina | — | — |
| Glenmark Investigational Site 6 | Nashville | Tennessee | — | — |
| Glenmark Investigational Site 60 | Baytown | Texas | — | — |
| Glenmark Investigational Site 27 | Houston | Texas | — | — |
| Glenmark Investigational Site 39 | Houston | Texas | — | — |
| Glenmark Investigational Site 8 | Houston | Texas | — | — |
| Glenmark Investigational Site 24 | Lampasas | Texas | — | — |
| Glenmark Investigational Site 37 | Missouri City | Texas | — | — |
| Glenmark Investigational Site 10 | Pflugerville | Texas | — | — |
| Glenmark Investigational Site 13 | San Antonio | Texas | — | — |
| Glenmark Investigational Site 26 | San Antonio | Texas | — | — |
| Glenmark Investigational Site 55 | San Antonio | Texas | — | — |
| Glenmark Investigational Site 38 | Sugar Land | Texas | — | — |
Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.
About this trial record page
- What this page shows
- Public field values for ClinicalTrials.gov record NCT02601703, including study identification, conditions, interventions, eligibility (age, sex, healthy volunteer), timeline, and U.S. site list.
- What this page does not do
- No medical advice, eligibility judgments, treatment recommendations, study quality scoring, or AI-generated medical summaries. No site contact phone numbers, emails, or investigator names.
- Where the data comes from
- Sourced from the official ClinicalTrials.gov public API. The official record is the source of truth.
- Last refresh
- Last update posted Jul 30, 2019 · Synced May 5, 2026
Related: full search, browse by condition, browse by drug or therapy, browse by sponsor, browse by U.S. city.
Open the official record
The complete protocol, eligibility criteria, and contact information for NCT02601703 live on ClinicalTrials.gov.