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
  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:


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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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 benzoate
Betamethasone
Betamethasone Valerate
Betamethasone sodium phosphate
Anti-Inflammatory Agents
Therapeutic Uses
Pharmacologic Actions
Glucocorticoids
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs
Anti-Asthmatic Agents
Respiratory System Agents

ClinicalTrials.gov processed this record on September 22, 2014