Bioequivalence Study of Pimecrolimus Cream, 1% and Elidel® Cream, 1% in Mild to Moderate Atopic Dermatitis
Public ClinicalTrials.gov record NCT03107611. 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, Prospective, Multicenter, Double Blind, Parallel Assignment, Placebo Controlled Bioequivalence Study of Pimecrolimus Cream, 1% and Elidel® (Pimecrolimus) Cream, 1% in Patients With Mild to Moderate Atopic Dermatitis
Brief summary
Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.
To establish the bioequivalence between test drug, Pimecrolimus Cream, 1% with that of reference listed drug, Elidel® (pimecrolimus) Cream 1%, in the treatment of mild to moderate Atopic Dermatitis. To establish superiority of each active treatment over the placebo.
Study identification
- NCT ID
- NCT03107611
- Recruitment status
- Completed
- Study type
- Interventional
- Phase
- Phase 3
- Enrollment
- 654 participants
Conditions and interventions
Conditions
Eligibility (public fields only)
- Age range
- 8 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
- Feb 28, 2016
- Primary completion
- May 14, 2017
- Completion
- May 14, 2017
- Last update posted
- Mar 6, 2022
2016 – 2017
United States locations
- U.S. sites
- 25
- U.S. states
- 15
- U.S. cities
- 24
| Facility | City | State | ZIP | Site status |
|---|---|---|---|---|
| Research Facility 6 | Boynton Beach | Florida | 33437 | — |
| Research Facility 4 | Coral Gables | Florida | 33146 | — |
| Research Facility 5 | Miami | Florida | 33144 | — |
| Research Facility 10 | Miami | Florida | 33175 | — |
| Research Facility 1 | Miami Lakes | Florida | 33014 | — |
| Research Facility 9 | Miramar | Florida | 33027 | — |
| Research Facility 33 | Sweetwater | Florida | 33172 | — |
| Research Facility 23 | Boise | Idaho | 83704 | — |
| Research Facility 28 | Overland Park | Kansas | 66215 | — |
| Research Facility 32 | Louisville | Kentucky | 40241 | — |
| Research Facility 13 | New Orleans | Louisiana | 70115 | — |
| Research Facility 7 | Saint Joseph | Missouri | 64506 | — |
| Research Facility 19 | Omaha | Nebraska | 68114 | — |
| Research Facility 29 | Albuquerque | New Mexico | 87106 | — |
| Research Facility 24 | Charlotte | North Carolina | 28277 | — |
| Research Facility 2 | High Point | North Carolina | 27262 | — |
| Resarch Facility 8 | Philadelphia | Pennsylvania | 19103 | — |
| Research Facility 18 | Johnston | Rhode Island | 02919 | — |
| Research Facility 20 | Austin | Texas | 78759 | — |
| Research Facility 16 | College Station | Texas | 77845 | — |
| Research Facility 31 | Pflugerville | Texas | 78660 | — |
| Research Facility 17 | Sugar Land | Texas | 77479 | — |
| Research Facility 22 | West Jordan | Utah | 84088 | — |
| Research Facility 15 | Richmond | Virginia | 23220 | — |
| Research Facility 26 | Spokane | Washington | 99202 | — |
Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.
Non-U.S. locations
This page focuses on the U.S. directory. The official record also lists 2 non-U.S. sites.
About this trial record page
- What this page shows
- Public field values for ClinicalTrials.gov record NCT03107611, 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 Mar 6, 2022 · Synced Sep 2, 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 NCT03107611 live on ClinicalTrials.gov.