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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

November 26, 2008
March 15, 2012
December 2002
January 2003   (final data collection date for primary outcome measure)
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 ]
Same as current
Complete list of historical versions of study NCT00800293 on ClinicalTrials.gov Archive Site
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Randomized Study to Compare the Bioavailability of Two Augmented Betamethasone Dipropionate 0.05% Topical Creams
Bioequivalence of Two Augmented Betamethasone Dipropionate 0.05% Topical Creams

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.

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Observational
Observational Model: Cohort
Time Perspective: Prospective
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Non-Probability Sample

Healthy Community Volunteers

Healthy
Drug: Betamethasone Dipropionate 0.05% Cream
Small amount applied and evaluated over the course of several hours
  • Cohort Group 1
    Subject Numbers 1 to 29
    Intervention: Drug: Betamethasone Dipropionate 0.05% Cream
  • Cohort Group 2
    Subject Numbers 20 to 59
    Intervention: Drug: Betamethasone Dipropionate 0.05% Cream
  • Cohort Group 3
    Subject Numbers 60 to 89
    Intervention: Drug: Betamethasone Dipropionate 0.05% Cream
  • Cohort Group 4
    Subject Numbers 90 to 116
    Intervention: Drug: Betamethasone Dipropionate 0.05% Cream
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*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
116
January 2003
January 2003   (final data collection date for primary outcome measure)

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
Female
18 Years to 50 Years
Yes
Contact information is only displayed when the study is recruiting subjects
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NCT00800293
10216925
No
Perrigo Company
Perrigo Company
Not Provided
Not Provided
Perrigo Company
March 2012

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP