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

Information source: Actavis Inc.
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Healthy

Intervention: Clobex TM (Clobetasol) 0.05% Lotion, single exposure (Drug)

Phase: Phase 1

Status: Completed

Sponsored by: Actavis Inc.

Official(s) and/or principal investigator(s):
Soran Hong,, M.D., Principal Investigator, Affiliation: Novum Pharmaceutical Research Services

Summary

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.

Clinical Details

Official title: Dose Response of Clobex 0.05% Lotion

Study design: Allocation: Randomized, Intervention Model: Single Group Assignment, Masking: Open Label

Primary outcome: Vasoconstriction response

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

Eligibility

Minimum age: 18 Years. Maximum age: 50 Years. Gender(s): Female.

Criteria:

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.

Locations and Contacts

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

CLOBETASOL

Starting date: October 2005
Last updated: August 13, 2010

Page last updated: August 23, 2015

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