Bio-equivalence Vasoconstriction Activity Study for Topically Applied Clocortolone Pivalate 0.1% Cream

Phase 1

Completed

• Conditions: Bioequivalence Study
• Interventions: Drug: Clocortolone Pivalate

• Registration Number: NCT04358770
• Lead Sponsor: Taro Pharmaceuticals USA

Brief Summary

To compare pharmacodynamic vasoconstriction response profile of Clocortolone Pivalate 0.1% Cream and Cloderm® (Clocortolone Pivalate) 0.1% Cream in normal skin of healthy male and female adults

Detailed Description

Not available

Study Timeline

• Study Start: 2018-03-02
• Primary Completion: 2018-04-27
• Study Completion: 2018-05-11
• Status Verified: 2020-04
• Study First Submitted: 2020-04-21
• Study First Submitted QC: 2020-04-22
• Last Update Submitted: 2020-04-22
• Study First Posted: 2020-04-24
• Last Update Posted: 2020-04-24

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 124

Inclusion Criteria

• Normal or clinically insignificant dermatological history the Screening visit and Day 1dosing;

Exclusion Criteria

• Female subjects who were pregnant, nursing, or planning to become pregnant during study participation;
• History of hypersensitivity to the study products or any topical or systemic corticosteroids;

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Reference	Clocortolone Pivalate	Cloderm® (clocortolone pivalate) Cream, 0.1%
Test	Clocortolone Pivalate	Clocortolone Pivalate Cream, 0.1%

Primary Outcome Measures

Name	Time	Method
AUEC0-24 (area under the effect curve)	24 hours	value for the blanching intensity vs. time profile

Trial Locations

Locations (1)

WayCro; 🇺🇸 Dallas, Texas, United States