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

Bioequivalence Study Clinical Trial

Official 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.

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04358770
• Other study ID #: CLPC-1801
• Status: Completed
• Phase: Phase 1
• Start date: March 2, 2018
• Est. completion date: May 11, 2018

Study information

• Verified date: April 2020
• Source: Taro Pharmaceuticals USA
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 124
• Est. completion date: May 11, 2018
• Est. primary completion date: April 27, 2018
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 35 Years

Eligibility

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;

Related Conditions & MeSH terms

• Bioequivalence Study

Intervention

Drug:
• Clocortolone Pivalate
Cream, 0.1%

Locations

Country	Name	City	State
United States	WayCro	Dallas	Texas

Sponsors (2)

Lead Sponsor	Collaborator
Taro Pharmaceuticals USA	WAYCro

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	AUEC0-24 (area under the effect curve)	value for the blanching intensity vs. time profile	24 hours