The Dose-response "Pilot" Study of Topically Delivered Clobetasol Propionate Lotion in Healthy Adult Subjects

July 8, 2019 updated by: Actavis Inc.

Dose Response of Clobex 0.05% Lotion

To determine the dose-response relationship for Clobex TM (clobetasol propionate) Lotion, 0.05%. This information will be used to estimate the ED50, D1, D2 parameters for use in a full bioequivalence study.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

Study Type: Interventional Study Design: Randomized, open label, one period, dose response, vasoconstrictor assay study.

Official Title: Dose Response of Clobex 0.05% Lotion

Further study details as provided by Actavis Elizabeth LLC:

Primary Outcome Measures:

· Vasoconstrictor Response

Study Type

Interventional

Enrollment (Actual)

15

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

  • United States
    • Texas
      • Houston, Texas, United States, 77042-4712
        • Novum Pharmaceutical Research Services

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 50 years (Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

Female

Description

Inclusion Criteria:

  • Non-tobacco-using female subjects, 18 to 50 years of age, inclusive.
  • A demonstrated blanching response to Clobex TM (clobetasol propionate) Lotion, 0.05 %.
  • A body mass index (BMI) 30 kg/m2 or less as calculated according to Novum Standard Operating Procedures.
  • Good health as determined by lack of clinically significant abnormalities in medical history and clinical assessment, as judged by the Investigator.
  • Signed and dated informed consent form which meets all criteria of current FDA regulations.

Exclusion Criteria:

  • History of allergy to any systemic or topical corticosteroid (including clobetasol) or to any cream, lotion, ointment, gel, cotton, soap, cosmetic, rubber, or tape, which in the opinion of the Investigator would compromise the safety of the subject or the study.
  • Presence of any skin condition or coloration that would interfere with placement of test sites or the response or assessment of skin blanching.
  • Significant history or current evidence of chronic infectious disease, system disorder (especially hypertension or circulatory disease), or organ dysfunction.
  • Presence of a medical condition requiring regular treatment with prescription drugs.
  • Drug or alcohol addiction requiring treatment (in-patient or out-patient) in the 12 months prior to dosing.
  • Use of any topical dermatological drug therapy (including topical corticosteroids) on the flexor surface of the ventral forearms in the 30 days prior to dosing.
  • Use of any tobacco products in the 30 days prior to dosing.
  • Receipt of any drug as part of a research study within 30 days prior to initial study dosing.
  • Pregnant or lactating.

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: Other
  • Allocation: Randomized
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: A
Clobex TM 0.05% Lotion, single exposure
Drug: Clobex TM (Clobetasol) 0.05% Lotion, single exposure
Subjects received Galderma Laboratories, L.P. formulated products
Other Names:
  • Clobetasol

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Vasoconstriction response
Time Frame: 24 hours
24 hours

Collaborators and Investigators

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

Sponsor

Actavis Inc.

Investigators

  • Principal Investigator: Soran Hong,, M.D., Novum Pharmaceutical Research Services

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

October 1, 2005

Primary Completion (Actual)

October 1, 2005

Study Completion (Actual)

October 1, 2005

Study Registration Dates

First Submitted

March 17, 2009

First Submitted That Met QC Criteria

March 17, 2009

First Posted (Estimate)

March 18, 2009

Study Record Updates

Last Update Posted (Actual)

July 9, 2019

Last Update Submitted That Met QC Criteria

July 8, 2019

Last Verified

July 1, 2019

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 10504909

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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