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.

Status

Completed

Phases

Phase 1

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT04358770

Enrollment

124

Registered

2020-04-24

Start date

2018-03-02

Completion date

2018-05-11

Last updated

2020-04-24

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Bioequivalence Study

Brief 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

Interventions

DRUGClocortolone Pivalate

Cream, 0.1%

Study design

Allocation

RANDOMIZED

Intervention model

SINGLE_GROUP

Primary purpose

HEALTH_SERVICES_RESEARCH

Masking

NONE

Intervention model description

single-exposure, open-label, vasoconstriction response study

Eligibility

Sex/Gender

ALL

Age

18 Years to 35 Years

Healthy volunteers

Yes

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;

Design outcomes

Primary

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

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026