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Randomized Study to Compare the Bioavailability of Two Augmented Betamethasone Dipropionate 0.05% Topical Creams

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Perrigo Company
ClinicalTrials.gov Identifier:
NCT00800293
First received: November 26, 2008
Last updated: March 15, 2012
Last verified: March 2012
History of Changes
  Purpose

The purpose of this study was to compare the relative vasoconstrictive effects of test and reference topical augmented betamethasone dipropionate augmented 0.05% cream in healthy, female subjects.


Condition Intervention Phase
Healthy
 Drug: Betamethasone Dipropionate 0.05% Cream
 Phase 1

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: Bioequivalence of Two Augmented Betamethasone Dipropionate 0.05% Topical Creams

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Perrigo Company:

Primary Outcome Measures:
  • Vasoconstriction will be measured by the degree of skin blanching observed after treatment removal using a ChromaMeter. [ Time Frame: Over the course of one day ] [ Designated as safety issue: No ]

Enrollment: 116
Study Start Date: December 2002
Study Completion Date: January 2003
Primary Completion Date: January 2003 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
Cohort Group 1
Subject Numbers 1 to 29
 Drug: Betamethasone Dipropionate 0.05% Cream
Small amount applied and evaluated over the course of several hours
Cohort Group 2
Subject Numbers 20 to 59
 Drug: Betamethasone Dipropionate 0.05% Cream
Small amount applied and evaluated over the course of several hours
Cohort Group 3
Subject Numbers 60 to 89
 Drug: Betamethasone Dipropionate 0.05% Cream
Small amount applied and evaluated over the course of several hours
Cohort Group 4
Subject Numbers 90 to 116
 Drug: Betamethasone Dipropionate 0.05% Cream
Small amount applied and evaluated over the course of several hours

  Eligibility

Ages Eligible for Study:   18 Years to 50 Years
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population

Healthy Community Volunteers

Criteria

Inclusion Criteria:

  • Non-tobacco-using female subjects, 18 to 50 years of age
  • Demonstrated blanching response to Reference Drug (augmented betamethasone dipropionate) Cream 0.05%
  • Weight within + or - 20% from normal for height and weight for body frame
  • 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 systemic or topical corticosteroids
  • Presence of any skin condition or coloration that would interfere with the placement of test sites or the response or assessment of skin blanching
  • Presence of medical condition requiring regular treatment with prescription drugs
  • Drug or alcohol addiction requiring treatment in the past 12 months prior to dosing
  • Use of any dermatological drug therapy on the flexor surface of the forearms within 30 days of dosing
  • Use of any tobacco products in the 30 days prior to study dosing
  • Receipt of any drugs as part of a research study within 30 days prior to study dosing
  • Pregnant or lactating
  Contacts and Locations
No Contacts or Locations Provided
  More Information

No publications provided

Responsible Party: Perrigo Company
ClinicalTrials.gov Identifier: NCT00800293     History of Changes
Other Study ID Numbers: 10216925
Study First Received: November 26, 2008
Last Updated: March 15, 2012
Health Authority: United States: Institutional Review Board

Keywords provided by Perrigo Company:
bioequivalence
betamethasone dipropionate
Bioequivalency

Additional relevant MeSH terms:
Betamethasone-17,21-dipropionate
Betamethasone
Betamethasone sodium phosphate
Anti-Inflammatory Agents
Therapeutic Uses
Pharmacologic Actions
 Anti-Asthmatic Agents
Respiratory System Agents
Glucocorticoids
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs

ClinicalTrials.gov processed this record on June 17, 2013