Pivotal Bioequivalence 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:
NCT00864500
First received: March 17, 2009
Last updated: August 13, 2010
Last verified: August 2010

March 17, 2009
August 13, 2010
November 2005
February 2006   (final data collection date for primary outcome measure)
Vasoconstrictor Response [ Time Frame: 24 hours ] [ Designated as safety issue: No ]
Same as current
Complete list of historical versions of study NCT00864500 on ClinicalTrials.gov Archive Site
Not Provided
Not Provided
Not Provided
Not Provided
 
Pivotal Bioequivalence Study of Topically Delivered Clobetasol Propionate Lotion in Healthy Adult Subjects
Bioequivalence of Two Clobetasol Propionate 0.05% Topical Lotions

To compare the relative vasoconstrictive effects of two topical clobetasol propionate 0.05% lotions in asymptomatic subjects.

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

Interventional
Phase 1
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Open Label
Healthy
  • Drug: Clobetasol Propionate 0.05% lotion, single exposure
    A: Experimental Subjects received Alpharma USPD, Inc formulated products
    Other Name: Clobetasol
  • Drug: Clobex TM 0.05% Lotion, single exposure
    B:Active Comparator Subjects received Galderma Laboratories, L.P. formulated products
    Other Name: Clobetasol
  • Experimental: A
    Clobetasol Propionate 0.05% lotion, single exposure
    Intervention: Drug: Clobetasol Propionate 0.05% lotion, single exposure
  • Active Comparator: B
    Clobex TM 0.05% Lotion, single exposure
    Intervention: Drug: Clobex TM 0.05% Lotion, single exposure
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
224
February 2006
February 2006   (final data collection date for primary outcome measure)

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.
Female
18 Years to 50 Years
Yes
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00864500
10504910
No
Christine Winslow, Director of Clinical Development, Actavis Inc
Actavis Inc.
Not Provided
Principal Investigator: Soran Hong,, M.D. Novum Pharmaceutical Research Services
Actavis Inc.
August 2010

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP