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

This study has been completed.
Sponsor:
Information provided by:
Actavis Inc.
ClinicalTrials.gov Identifier:
NCT00864240
First received: March 17, 2009
Last updated: August 13, 2010
Last verified: August 2010
  Purpose

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.


Condition Intervention Phase
Healthy
Drug: Clobex TM (Clobetasol) 0.05% Lotion, single exposure
Phase 1

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: Open Label
Official Title: Dose Response of Clobex 0.05% Lotion

Resource links provided by NLM:


Further study details as provided by Actavis Inc.:

Primary Outcome Measures:
  • Vasoconstriction response [ Time Frame: 24 hours ] [ Designated as safety issue: No ]

Enrollment: 15
Study Start Date: October 2005
Study Completion Date: October 2005
Primary Completion Date: October 2005 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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 Name: Clobetasol

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

Ages Eligible for Study:   18 Years to 50 Years
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
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.
  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: NCT00864240

Locations
United States, Texas
Novum Pharmaceutical Research Services
Houston, Texas, United States, 77042-4712
Sponsors and Collaborators
Actavis Inc.
Investigators
Principal Investigator: Soran Hong,, M.D. Novum Pharmaceutical Research Services
  More Information

Additional Information:
No publications provided

Responsible Party: Christine Winslow, Director of Clinical Development, Actavis Inc
ClinicalTrials.gov Identifier: NCT00864240     History of Changes
Other Study ID Numbers: 10504909
Study First Received: March 17, 2009
Last Updated: August 13, 2010
Health Authority: United States: Institutional Review Board

Keywords provided by Actavis Inc.:
Vasoconstriction
Clobetasol
Healthy adult females

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

ClinicalTrials.gov processed this record on October 21, 2014