Study of Equivalence of Generic Pimecrolimus Cream 1% and Elidel® 1% in Subjects With Mild to Moderate Atopic Dermatitis
Public ClinicalTrials.gov record NCT02791308. 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
Double-Blind Randomized Vehicle Controlled Study Evaluating Safety and Bioequivalence of Generic Pimecrolimus Cream 1% and Elidel® Comparing Both Active Treatments to a Vehicle Control in Treatment of Mild to Moderate Atopic Dermatitis
Brief summary
Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.
The purpose of this study is to compare the safety and efficacy profiles of Watson Laboratories, Inc.'s Pimecrolimus Cream, 1% to those of Valeant Pharmaceuticals North America LLC's Elidel® (pimecrolimus) Cream, 1%, and to demonstrate the superior efficacy of the two active creams over that of the placebo (Vehicle of test product), in the treatment of mild to moderate atopic dermatitis.
Study identification
- NCT ID
- NCT02791308
- Recruitment status
- Completed
- Study type
- Interventional
- Phase
- Phase 3
- Enrollment
- 587 participants
Conditions and interventions
Conditions
Interventions
- Pimecrolimus Cream 1% (Valeant) Drug
- Vehicle cream Drug
- Pimecrolimus Cream, 1% Drug
Drug
Eligibility (public fields only)
- Age range
- 12 Years to 90 Years
- Sex
- All
- Healthy volunteers
- Accepts healthy volunteers
This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.
Study timeline
- Start date
- Feb 2015 (Type not available)
- Primary completion
- Jul 2016 (Actual)
- Completion
- Jul 2016 (Actual)
- Last update posted
- May 29, 2020
2015 – 2016
United States locations
- U.S. sites
- 53
- U.S. states
- 26
- U.S. cities
- 50
| Facility | City | State | ZIP | Site status |
|---|---|---|---|---|
| Pinnacle Research Group, LLC | Anniston | Alabama | 36207 | — |
| Clinical Research Center of Alabama | Birmingham | Alabama | 35209 | — |
| Agave Clinical Research, LLC | Mesa | Arizona | 85202 | — |
| Omni Dermatology/Physicians Research Group, LLC | Phoenix | Arizona | 85018 | — |
| Northwest Arkansas Clinical Trials Center, PLLC | Rogers | Arkansas | 72758 | — |
| MD Studies, Inc. | Fountain Valley | California | 92708 | — |
| Alliance Research Centers | Laguna Hills | California | 92653 | — |
| Medical Center for Clinical Research | San Diego | California | 92108 | — |
| Skin Surgery Medical Group, Inc. | San Diego | California | 92117 | — |
| Horizons Clinical Research Ctr., LLC | Denver | Colorado | 80220 | — |
| Immunoe International Research Centers | Thornton | Colorado | 80233 | — |
| Dermatology of Boca | Boca Raton | Florida | 33431 | — |
| Olympian Clinical Research | Clearwater | Florida | 33757 | — |
| International Dermatology Research, Inc. | Miami | Florida | 33144 | — |
| Radiant Research, Inc. | Pinellas Park | Florida | 33781 | — |
| International Clinical Research- US, LLC | Sanford | Florida | 32771 | — |
| MOORE Clinical Research, Inc. | Tampa | Florida | 33609 | — |
| Olympian Clinical Research | Tampa | Florida | 33609 | — |
| Kansas City Dermatology PA | Overland Park | Kansas | 66215 | — |
| Kentucky Pediatric/Adult Research | Bardstown | Kentucky | 40004 | — |
| Dermatology Specialists Research | Louisville | Kentucky | 40202 | — |
| Callender Center for Clinical Research, LLC | Glenn Dale | Maryland | 20769 | — |
| David Fivenson, MD, PLC | Ann Arbor | Michigan | 48103 | — |
| Minnesota Clinical Study Center | Fridley | Minnesota | 55432 | — |
| MediSearch Clinical Trials | Saint Joseph | Missouri | 64506 | — |
| Quality Clinical Research Inc. | Omaha | Nebraska | 68114 | — |
| Karl G. Heine, MD Dermatology | Henderson | Nevada | 89052 | — |
| Academic Dermatology Associates | Albuquerque | New Mexico | 87106 | — |
| Pinkas E. Lebovits, MD, PC | New York | New York | 10019 | — |
| Piedmont Plastic Surgery and Dermatology | Charlotte | North Carolina | 28277 | — |
| Dermatology Consulting Services | High Point | North Carolina | 27262 | — |
| PMG Research of Winston-Salem, LLC | Winston-Salem | North Carolina | 27103 | — |
| Cyn3rgy Research | Gresham | Oregon | 97030 | — |
| Baker Allergy, Asthma and Dermatology Research Center, LLC | Portland | Oregon | 97223 | — |
| Asthma & Allergy Research Associates | Upland | Pennsylvania | 19013 | — |
| Clinical Partners, LLC | Johnston | Rhode Island | 02919 | — |
| Greenville Dermatology | Greenville | South Carolina | 29607 | — |
| Spartanburg Medical Research | Spartanburg | South Carolina | 29303 | — |
| ClinSearch, LLC | Chattanooga | Tennessee | 37421 | — |
| Tennessee Clinical Research Center | Nashville | Tennessee | 37215 | — |
| J&S Studies, Inc. | College Station | Texas | 77845 | — |
| Suzanne Bruce and Associates, P.A./The Center for Skin Research | Houston | Texas | 77056 | — |
| Center for Clinical Studies | Houston | Texas | 77065 | — |
| Suzanne Bruce and Associates, P.A., The Center for Skin Research | Katy | Texas | 77494 | — |
| R/D Clinical Research, Inc. | Lake Jackson | Texas | 77566 | — |
| Pflugerville Dermatology Clinical Research Center, Inc. | Pflugerville | Texas | 78660 | — |
| ACRC Trials | Plano | Texas | 75024 | — |
| Texas Dermatology and Laser Specialists | San Antonio | Texas | 78218 | — |
| Intermountain Clinical Research | Draper | Utah | 84020 | — |
| The Education and Research Foundation, Inc. | Lynchburg | Virginia | 24501 | — |
| National Clinical Research-Richmond, Inc. | Richmond | Virginia | 23294 | — |
| Dermatology Associates | Seattle | Washington | 98101 | — |
| Eastern Washington Dermatology | Walla Walla | Washington | 99362 | — |
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 NCT02791308, 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 May 29, 2020 · Synced Oct 18, 2026
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Open the official record
The complete public registry record, listed eligibility criteria, and available contact information for NCT02791308 live on ClinicalTrials.gov.