Clinical trial NCT00864240: The Dose-response "Pilot" Study of Topically Delivered Clobetasol Propionate Lotion in Healthy Adult Subjects
Official title: Dose Response of Clobex 0.05% Lotion
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Healthy
Keywords: Vasoconstriction
Clobetasol
Healthy adult females
Lead sponsor: Actavis Inc.
Sponsor class: INDUSTRY
First posted: 2009-03-18
Enrollment: 15
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 50
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: OTHER

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.

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

Eligibility 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.

Primary outcomes:
measure: Vasoconstriction response
timeFrame: 24 hours
Secondary outcomes:
Other outcomes:
Locations:
city: Houston
country: United States
facility: Novum Pharmaceutical Research Services
state: Texas
Study officials:
affiliation: Novum Pharmaceutical Research Services
name: Soran Hong,, M.D.
role: PRINCIPAL_INVESTIGATOR
References: