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

Taro Pharmaceuticals

Status and phase: Completed; Phase 1

Conditions: Bioequivalence Study

Treatments: Drug: Clocortolone Pivalate

Study type: Interventional

Funder types: Industry; Other

Identifiers

NCT04358770

CLPC-1801

Details and patient eligibility

About

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

Enrollment: 124 patients

Sex: All

Ages: 18 to 35 years old

Volunteers: Accepts Healthy Volunteers

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;

Trial design

Primary purpose: Health Services Research

Allocation: Randomized

Interventional model: Single Group Assignment

Masking: None (Open label)

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124 participants in 2 patient groups

Test

Experimental group

Description:

Clocortolone Pivalate Cream, 0.1%

Treatment:

Drug: Clocortolone Pivalate

Reference

Active Comparator group

Description:

Cloderm® (clocortolone pivalate) Cream, 0.1%

Treatment:

Drug: Clocortolone Pivalate