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Pivotal Bioequivalence Study of Topically Delivered Clobetasol Propionate Lotion in Healthy Adult Subjects

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00864500
First Posted: March 18, 2009
Last Update Posted: August 16, 2010
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by:
Actavis Inc.
  Purpose
To compare the relative vasoconstrictive effects of two topical clobetasol propionate 0.05% lotions in asymptomatic subjects.

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

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)
Official Title: Bioequivalence of Two Clobetasol Propionate 0.05% Topical Lotions

Resource links provided by NLM:


Further study details as provided by Actavis Inc.:

Primary Outcome Measures:
  • Vasoconstrictor Response [ Time Frame: 24 hours ]

Enrollment: 224
Study Start Date: November 2005
Study Completion Date: February 2006
Primary Completion Date: February 2006 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: A
Clobetasol Propionate 0.05% lotion, single exposure
Drug: Clobetasol Propionate 0.05% lotion, single exposure
A: Experimental Subjects received Alpharma USPD, Inc formulated products
Other Name: Clobetasol
Active Comparator: B
Clobex TM 0.05% Lotion, single exposure
Drug: Clobex TM 0.05% Lotion, single exposure
B:Active Comparator Subjects received Galderma Laboratories, L.P. formulated products
Other Name: Clobetasol

Detailed Description:

Study Type: Interventional Study Design: An open label, one period, randomized, vasoconstrictor assay study.

Official Title: Bioequivalence of two Clobetasol Propionate 0.05% Topical Lotions

Further study details as provided by Actavis Elizabeth LLC:

Primary Outcome Measures:

· Vasoconstrictor Response

  Eligibility

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.
  Contacts and Locations
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): NCT00864500


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:
Responsible Party: Christine Winslow, Director of Clinical Development, Actavis Inc
ClinicalTrials.gov Identifier: NCT00864500     History of Changes
Other Study ID Numbers: 10504910
First Submitted: March 17, 2009
First Posted: March 18, 2009
Last Update Posted: August 16, 2010
Last Verified: August 2010

Keywords provided by Actavis Inc.:
Bio-Equivalence
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