The Dose-response Study of Topically Delivered Halobetasol Propionate Ointment in Normal Skin in Healthy Adult Subjects

This study has been completed.
Sponsor:
Information provided by:
Actavis Inc.
ClinicalTrials.gov Identifier:
NCT00865267
First received: March 17, 2009
Last updated: August 13, 2010
Last verified: August 2010
  Purpose

The purpose of this study is to determine the duration of application of halobetasol propionate 0.05% ointment to be used in a definitive study of bioequivalence of to formulations of this ointment.

Part A: To validate vasoconstrictor assay precision.

Part B: To evaluate the dose response vasoconstriction profile of Ultravate® 0.05% ointment at different dose durations over a short period of time (0.17 - 4 hrs).


Condition Intervention Phase
Healthy
Drug: Ultravate® 0.05% ointment, single exposure
Phase 1

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment
Masking: Single Blind (Subject)
Official Title: A Single-blind, Single Exposure Study, to Evaluate the Vasoconstriction Activity of Topically Delivered Halobetasol Propionate Ointment in Normal Skin in Healthy Adult Subjects: Dose Ranging Study

Resource links provided by NLM:


Further study details as provided by Actavis Inc.:

Primary Outcome Measures:
  • Vasoconstriction response [ Time Frame: 36 hours ] [ Designated as safety issue: No ]

Enrollment: 20
Study Start Date: December 2003
Study Completion Date: December 2003
Primary Completion Date: December 2003 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: A
Ultravate® 0.05% ointment, single exposure
Drug: Ultravate® 0.05% ointment, single exposure
A: Experimental Subjects received Bristol-Myers Squibb Company formulated products
Other Name: Halobetasol

Detailed Description:

Study Type: Interventional Study Design: A single blind, single-exposure study on healthy adult male and female subjects.

Official Title: A Single-blind, Single Exposure Study, to Evaluate the Vasoconstriction Activity of Topically Delivered Halobetasol Propionate Ointment in Normal Skin in Healthy Adult Subjects: Dose Ranging Study

Further study details as provided by Actavis Elizabeth LLC:

Primary Outcome Measures:

Vasoconstrictor Response

  Eligibility

Ages Eligible for Study:   18 Years to 65 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Subject understands the study, is willing to participate, and gives written informed consent.
  • Subject demonstrates adequate vasoconstriction to the screening topical corticosteroid Halobetasol propionate 0.05% Ointment.
  • Subject is a non-smoking (minimum of 14 days), male or female, ages of 18 - 65 years, inclusive.
  • Subject is within 20% of their ideal body weight as defined by the 1999 Metropolitan Life Insurance Company Height and Weight Tables.
  • Subject is judged by the Investigator to be healthy on the basis of pre-study medical history.
  • Subjects of child-bearing potential agree to use an acceptable method of birth control during study participation (e.g. abstinence, any prescribed birth control method, double barrier method, Le. condom plus foam, condom plus diaphragm).
  • Subject is willing to refrain from excessive consumption of sodium in food or beverage 48hrs before and for the duration of the study.
  • Subject is willing to shower using the same soap/cleansers for the duration of the study.
  • Subject is willing to follow study restrictions.

Exclusion Criteria:

  • Subject has a past or current medical condition that might significantly affect pharmacodynamic response to topical corticosteroids.
  • Subject has clinically significant hypertension or circulatory disease.
  • Subject is taking any medication on a regular basis that could modulate blood flow (constrictor or dilator), with the exception of any prescribed birth control method and hormone replacement therapy. Examples of such drugs include nitroglycerin, anti-hypertensives, antihistamines, NSAIDs, aspirin, phenylpropanolamine, or phentolamine.
  • Subject is planning to use any exclusionary over-the-counter (OTC) medications within 48 hours prior to or throughout the study that could modulate blood.
  • Subject has a history of sensitivity/allergy to the ingredients found in the test formulations or has a history of adverse reactions to topical or systemic corticosteroids.
  • Subject has a significant history of allergy to soaps, lotions, emollients, creams, ointments, cosmetics, adhesives, or latex.
  • Subject has a history of significant skin conditions or disorders, for example, psoriasis, atopic dermatitis, actinic keratosis, etc.
  • Subject has an obvious difference In skin color between arms or the presence of a skin condition, scar tissue, tattoo or coloration that would interfere with placement of test sites, their assessments or could compromise the safety of the subject.
  • Subject has used topical medications on the ventral forearms within 1 month prior to dosing.
  • Subject has used a tobacco product within 14 days of study conduct.
  • Subject has a clinically significant history of drug abuse or alcoholism.
  • Subject has donated or received blood within 30 days prior to dosing.
  • Subject's caffeine intake is greater than 500 mg per day (1 cup of coffee contains approximately 85 mg of caffeine).
  • Subject plans consumption of alcohol, or consumption of caffeine within 48 hours of study conduct or throughout the entire dosing and evaluation period of the study.
  • (Females only): Subject is pregnant or lactating.
  • Subject has participated in another investigational drug, medical device, or biologics study within 30 days prior to dosing.

formed on all females).

  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00865267

Locations
United States, California
DermTech International
San Diego, California, United States, 92128
Sponsors and Collaborators
Actavis Inc.
Investigators
Principal Investigator: Paul A. Lehman,, M.Sc. DermTech International
  More Information

Additional Information:
No publications provided

Responsible Party: Christine Winslow, Director of Clinical Development, Actavis Inc
ClinicalTrials.gov Identifier: NCT00865267     History of Changes
Other Study ID Numbers: DP03-685
Study First Received: March 17, 2009
Last Updated: August 13, 2010
Health Authority: United States: Institutional Review Board

Keywords provided by Actavis Inc.:
Vasoconstriction
Halobetasol
Healthy adult subjects

Additional relevant MeSH terms:
Halobetasol
Clobetasol
Vasoconstrictor Agents
Cardiovascular Agents
Therapeutic Uses
Pharmacologic Actions
Anti-Inflammatory Agents
Glucocorticoids
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs

ClinicalTrials.gov processed this record on July 23, 2014