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

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.

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

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;