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Completed Phase 3 Interventional Results available

Bioequivalence Study of Pimecrolimus Cream, 1% and Elidel® Cream, 1% in Mild to Moderate Atopic Dermatitis

ClinicalTrials.gov ID: NCT03107611

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.

ClinicalTrials.gov public records Last synced Oct 18, 2026, 2:04 AM EDT

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
Lead sponsor
Mylan Inc.
Industry
Enrollment
654 participants

Conditions and interventions

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 29, 2016 (Actual)
Primary completion
May 15, 2017 (Actual)
Completion
May 15, 2017 (Actual)
Last update posted
Mar 7, 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 7, 2022 · Synced Oct 18, 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 public registry record, listed eligibility criteria, and available contact information for NCT03107611 live on ClinicalTrials.gov.

View official ClinicalTrials.gov record →