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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE1

Total Enrollment

124 participants

Study Classification

INTERVENTIONAL

Study Start Date

2018-03-02

Study Completion Date

2018-05-11

Brief Summary

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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

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Detailed Description

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Conditions

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Bioequivalence Study

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

SINGLE_GROUP

single-exposure, open-label, vasoconstriction response study

Primary Study Purpose

HEALTH_SERVICES_RESEARCH

Blinding Strategy

NONE

Study Groups

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Test

Clocortolone Pivalate Cream, 0.1%

Group Type EXPERIMENTAL

Clocortolone Pivalate

Intervention Type DRUG

Cream, 0.1%

Reference

Cloderm® (clocortolone pivalate) Cream, 0.1%

Group Type ACTIVE_COMPARATOR

Clocortolone Pivalate

Intervention Type DRUG

Cream, 0.1%

Interventions

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Clocortolone Pivalate

Cream, 0.1%

Intervention Type DRUG

Other Intervention Names

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Clocortolone

Eligibility Criteria

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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;

Minimum Eligible Age

18 Years

Maximum Eligible Age

35 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes