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

April 22, 2020 updated by: Taro Pharmaceuticals USA

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

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

124

Phase

  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 35 years (ADULT)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

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;

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: HEALTH_SERVICES_RESEARCH
  • Allocation: RANDOMIZED
  • Interventional Model: SINGLE_GROUP
  • Masking: NONE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
EXPERIMENTAL: Test
Clocortolone Pivalate Cream, 0.1%
Drug: Clocortolone Pivalate
Cream, 0.1%
Other Names:
  • Clocortolone
ACTIVE_COMPARATOR: Reference
Cloderm® (clocortolone pivalate) Cream, 0.1%
Drug: Clocortolone Pivalate
Cream, 0.1%
Other Names:
  • Clocortolone

What is the study measuring?

Primary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Taro Pharmaceuticals USA

Collaborators

WAYCro

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ACTUAL)

March 2, 2018

Primary Completion (ACTUAL)

April 27, 2018

Study Completion (ACTUAL)

May 11, 2018

Study Registration Dates

First Submitted

April 21, 2020

First Submitted That Met QC Criteria

April 22, 2020

First Posted (ACTUAL)

April 24, 2020

Study Record Updates

Last Update Posted (ACTUAL)

April 24, 2020

Last Update Submitted That Met QC Criteria

April 22, 2020

Last Verified

April 1, 2020

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CLPC-1801

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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