Trials / Completed
CompletedNCT03107611
Bioequivalence Study of Pimecrolimus Cream, 1% and Elidel® Cream, 1% in Mild to Moderate Atopic Dermatitis
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
- Status
- Completed
- Phase
- Phase 3
- Study type
- Interventional
- Enrollment
- 654 (actual)
- Sponsor
- Mylan Inc. · Industry
- Sex
- All
- Age
- 8 Years
- Healthy volunteers
- Not accepted
Summary
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.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | Pimecrolimus Cream, 1% | |
| DRUG | Placebo Cream | |
| DRUG | Pimecrolimus Cream, 1% |
Timeline
- Start date
- 2016-02-29
- Primary completion
- 2017-05-15
- Completion
- 2017-05-15
- First posted
- 2017-04-11
- Last updated
- 2022-03-07
- Results posted
- 2020-03-17
Locations
27 sites across 3 countries: United States, Dominican Republic, Honduras
Regulatory
- FDA-regulated drug study
Source: ClinicalTrials.gov record NCT03107611. Inclusion in this directory is not an endorsement.