CI

At a glance

ClinicalIndex Comparison Record
Phase 3Completed· 654 enrolled
Drug / intervention
Pimecrolimus Cream, 1% +2 moredrug
Likely dose
Pimecrolimus Cream, 1%AI-extracted
Key inclusion· 8
  • ✓Age 8 years or older
  • ✓Non-immunocompromised
  • ✓Clinical diagnosis of mild to moderate atopic dermatitis
  • ✓Failed to respond adequately to other topical prescription treatments or those treatments not advisable
Key exclusion· 7
  • ✕Pregnant, breastfeeding, or planning pregnancy during study
  • ✕Active cutaneous bacterial or viral infection in treatment area
  • ✕Sunburn, extensive scarring, or pigmented lesions in treatment area that would interfere with evaluations
  • ✕Confounding skin conditions (psoriasis, rosacea, erythroderma, ichthyosis, scabies)

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT03107611
NCT03107611Phase 3Completed
CompareCT.gov

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

Mylan Inc.·interventional·Posted Apr 11, 2017·Updated Mar 7, 2022

In Brief

A Phase 3 clinical trial evaluating Pimecrolimus Cream, 1% and Placebo Cream for Atopic Dermatitis. Completed, enrolled 654 participants across 27 sites in 3 countries.

Detailed 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.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsAtopic Dermatitis
CountriesDominican Republic, Honduras, United States
CollaboratorsDPT Laboratories, Ltd.

Timeline

Phase 3CompletedFinished
20162017201820192020202120222023202420252026
First PostedApr 11, 2017
Enrollment StartFeb 29, 2016
Primary CompletionMay 15, 2017
TodayJul 2, 2026
Enrollment to primary: 1.2 yearsPosted 9.2 years ago

Interventions

Pimecrolimus Cream, 1%drug

Placebo Creamdrug

Pimecrolimus Cream, 1%drug