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

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

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Key information

Conditions

Bioequivalence Study

Age range

18 year–35 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

WayCro

Dallas, Texas, 75234, United States

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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;

Treatment and study plan

Clocortolone Pivalate

Drug

Cream, 0.1%

Other names: Clocortolone

Primary outcomes

AUEC0-24 (area under the effect curve)

Time frame: 24 hours

value for the blanching intensity vs. time profile

Sponsors and collaborators

Lead sponsor

Sun Pharmaceutical Industries, Inc.

Industry

Collaborators

WAYCro

Registry information

Official study title

Single Exposure Bioequivalence Study to Evaluate the Vasoconstriction Activity of Topically Applied Cloderm® (Clocortolone Pivalate) 0.1% Cream and Clocortolone Pivalate 0.1% Cream (Taro Pharmaceuticals) in Healthy Male and Female Volunteers With Normal Skin Under Occlusive Conditions.

Important dates

Study start: 2018
Primary completion: 2018
Study completion: 2018
First posted: Apr 24, 2020
Registry last updated: Apr 24, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.

Completed