- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00864500
Pivotal Bioequivalence Study of Topically Delivered Clobetasol Propionate Lotion in Healthy Adult Subjects
July 8, 2019 updated by: Actavis Inc.
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 Overview
Status
Completed
Conditions
Intervention / Treatment
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
Interventional
Enrollment (Actual)
224
Phase
- Phase 1
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
Texas
-
Houston, Texas, United States, 77042-4712
- Novum Pharmaceutical Research Services
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
16 years to 48 years (Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
Female
Description
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.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Other
- Allocation: Randomized
- Interventional Model: Crossover Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: A
Clobetasol Propionate 0.05% lotion, single exposure
|
A: Experimental Subjects received Alpharma USPD, Inc formulated products
Other Names:
|
Active Comparator: B
Clobex TM 0.05% Lotion, single exposure
|
B:Active Comparator Subjects received Galderma Laboratories, L.P. formulated products
Other Names:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Vasoconstrictor Response
Time Frame: 24 hours
|
24 hours
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Principal Investigator: Soran Hong,, M.D., Novum Pharmaceutical Research Services
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
November 1, 2005
Primary Completion (Actual)
February 1, 2006
Study Completion (Actual)
February 1, 2006
Study Registration Dates
First Submitted
March 17, 2009
First Submitted That Met QC Criteria
March 17, 2009
First Posted (Estimate)
March 18, 2009
Study Record Updates
Last Update Posted (Actual)
July 9, 2019
Last Update Submitted That Met QC Criteria
July 8, 2019
Last Verified
July 1, 2019
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 10504910
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Healthy
-
Prevent Age Resort "Pervaya Liniya"RecruitingHealthy Aging | Healthy Diet | Healthy LifestyleRussian Federation
-
Maastricht University Medical CenterCompletedHealthy Volunteers | Healthy Subjects | Healthy AdultsNetherlands
-
Yale UniversityNot yet recruitingHealth-related Benefits of Introducing Table Olives Into the Diet of Young Adults: Olives For HealthHealthy Diet | Healthy Lifestyle | Healthy Nutrition | CholesterolUnited States
-
Hasselt UniversityRecruitingHealthy | Healthy AgingBelgium
-
Galera Therapeutics, Inc.Syneos HealthCompleted
-
Galera Therapeutics, Inc.Syneos HealthCompletedHealthy | Healthy VolunteersAustralia
-
University of PennsylvaniaActive, not recruitingHealthy | Healthy AgingUnited States
-
Chalmers University of TechnologyGöteborg UniversityCompletedHealthy | Nutrition, HealthySweden
-
University of ManitobaNot yet recruitingHealthy | Healthy Diet
Clinical Trials on Clobetasol Propionate 0.05% lotion, single exposure
-
Actavis Inc.Completed
-
Actavis Inc.Completed
-
Galderma R&DCompleted
-
Padagis LLCCompleted
-
Galderma R&DCompleted
-
Galderma R&DCompletedScalp PsoriasisCanada
-
SalvatCompleted
-
SalvatCompleted
-
Hill Dermaceuticals, Inc.Covance; Synteract, Inc.TerminatedAtopic DermatitisUnited States
-
Galderma R&DCompletedScalp PsoriasisUnited States