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OpenTrials
Completed

NCT Number: NCT00803465

Randomized Study to Compare the Bioequivalence of Two Fluticasone Propionate 0.05% Topical Creams

The purpose of this study was to compare the relative vasoconstrictive effects of test and reference topical Fluticasone Propionate 0.05% Cream in healthy, female subjects.

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Key information

Conditions

Age range

18 year–50 year

Sex eligibility

Female

Study type

Observational

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Non-tobacco using female subjects, 18 to 50 years of age
  • Demonstrated blanching response to Reference Drug
  • Weight within +/- 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 tobacco products in the 30 days prior to study dosing
  • Use of any dermatological drug therapy on the flexor surface of the forearms within 30 days of dosing
  • Receipt of any drugs as part of a research study within 30 days prior to study dosing
  • Pregnant or lactating

Treatment and study plan

Fluticasone Propionate 0.05% Cream-Reference Product

Drug

Small amount applied and evaluated over the course of two days

Fluticasone Propionate 0.05% Cream-Test product

Drug

Small amount applied and evaluated over the course of two days

Primary outcomes

  1. Vasoconstriction will be measured by the degree of skin blanching observed after treatment removal using a ChromaMeter

    Time frame: Over the course of two days

Sponsors and collaborators

Lead sponsor

Padagis LLC

Industry

Registry information

Official study title

Bioequivalence of Two Fluticasone Propionate 0.05% Topical Creams

Important dates

Study start
2003
Primary completion
2003
Study completion
2003
First posted
Dec 5, 2008
Registry last updated
Oct 18, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.