Pivotal Bioequivalence Study of Topically Delivered Clobetasol Propionate Lotion in Healthy Adult Subjects
Information source: Actavis Inc.
ClinicalTrials.gov processed this data on August 23, 2015 Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Healthy
Intervention: Clobetasol Propionate 0.05% lotion, single exposure (Drug); Clobex TM 0.05% Lotion, single exposure (Drug)
Phase: Phase 1
Status: Completed
Sponsored by: Actavis Inc. Official(s) and/or principal investigator(s): Soran Hong,, M.D., Principal Investigator, Affiliation: Novum Pharmaceutical Research Services
Summary
To compare the relative vasoconstrictive effects of two topical clobetasol propionate 0. 05%
lotions in asymptomatic subjects.
Clinical Details
Official title: Bioequivalence of Two Clobetasol Propionate 0.05% Topical Lotions
Study design: Allocation: Randomized, Intervention Model: Crossover Assignment, Masking: Open Label
Primary outcome: Vasoconstrictor Response
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
Minimum age: 18 Years.
Maximum age: 50 Years.
Gender(s): Female.
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.
Locations and Contacts
Novum Pharmaceutical Research Services, Houston, Texas 77042-4712, United States
Additional Information
CLOBETASOL
Starting date: November 2005
Last updated: August 13, 2010
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