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

Tracking Information
First Submitted Date ICMJE	March 17, 2009
First Posted Date ICMJE	March 18, 2009
Last Update Posted Date	August 16, 2010
Study Start Date ICMJE	November 2005
Actual Primary Completion Date	February 2006 (Final data collection date for primary outcome measure)
Current Primary Outcome Measures ICMJE; (submitted: March 17, 2009)	Vasoconstrictor Response [ Time Frame: 24 hours ]
Original Primary Outcome Measures ICMJE	Same as current
Change History	Complete list of historical versions of study NCT00864500 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures ICMJE	Not Provided
Original Secondary Outcome Measures ICMJE	Not Provided
Current Other Outcome Measures ICMJE	Not Provided
Original Other Outcome Measures ICMJE	Not Provided
Descriptive Information
Brief Title ICMJE	Pivotal Bioequivalence Study of Topically Delivered Clobetasol Propionate Lotion in Healthy Adult Subjects
Official Title ICMJE	Bioequivalence of Two Clobetasol Propionate 0.05% Topical Lotions
Brief Summary	To compare the relative vasoconstrictive effects of two topical clobetasol propionate 0.05% lotions in asymptomatic subjects.
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
Study Type ICMJE	Interventional
Study Phase	Phase 1
Study Design ICMJE	Allocation: Randomized; Intervention Model: Crossover Assignment; Masking: None (Open Label)
Condition ICMJE	Healthy
Intervention ICMJE	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
Study Arms	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
Publications *	Not Provided
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
Recruitment Information
Recruitment Status ICMJE	Completed
Actual Enrollment ICMJE; (submitted: March 17, 2009)	224
Original Actual Enrollment ICMJE	Same as current
Actual Study Completion Date	February 2006
Actual Primary Completion Date	February 2006 (Final data collection date for primary outcome measure)
Eligibility Criteria ICMJE	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.
Sex/Gender	Sexes Eligible for Study: Female
Ages	18 Years to 50 Years (Adult)
Accepts Healthy Volunteers	Yes
Contacts ICMJE	Contact information is only displayed when the study is recruiting subjects
Listed Location Countries ICMJE	United States
Removed Location Countries
Administrative Information
NCT Number ICMJE	NCT00864500
Other Study ID Numbers ICMJE	10504910
Has Data Monitoring Committee	No
U.S. FDA-regulated Product	Not Provided
IPD Sharing Statement	Not Provided
Responsible Party	Christine Winslow, Director of Clinical Development, Actavis Inc
Study Sponsor ICMJE	Actavis Inc.
Collaborators ICMJE	Not Provided
Investigators ICMJE	Principal Investigator: Soran Hong,, M.D. Novum Pharmaceutical Research Services
PRS Account	Actavis Inc.
Verification Date	August 2010
ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP