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

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ClinicalTrials.gov Identifier: NCT00864240
Recruitment Status : Completed
First Posted : March 18, 2009
Last Update Posted : August 16, 2010
Sponsor:
Information provided by:
Actavis Inc.

Brief 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.

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

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  (Clinical Trial)
Actual Enrollment : 15 participants
Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Official Title: Dose Response of Clobex 0.05% Lotion
Study Start Date : October 2005
Actual Primary Completion Date : October 2005
Actual Study Completion Date : October 2005

Resource links provided by the National Library of Medicine

U.S. FDA Resources

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 Name: Clobetasol



Primary Outcome Measures :
  1. Vasoconstriction response [ Time Frame: 24 hours ]


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 50 Years   (Adult)
Sexes 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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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

Additional Information:
Responsible Party: Christine Winslow, Director of Clinical Development, Actavis Inc
ClinicalTrials.gov Identifier: NCT00864240     History of Changes
Other Study ID Numbers: 10504909
First Posted: March 18, 2009    Key Record Dates
Last Update Posted: August 16, 2010
Last Verified: August 2010

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
Physiological Effects of Drugs