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

• Status: Completed
• Trial end date: 2018-05-11
• Target enrollment: 0
• Participant gender: All

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

• Phase: Phase 1
• Accepts Healthy Volunteers?: Accepts Healthy Volunteers

Details

• Lead Sponsor: Taro Pharmaceuticals USA
• Collaborator: WAYCro
• Treatments: Clocortolone; Clocortolone pivalate; Fluocortolone

Criteria

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;