Randomized Study to Compare the Bioavailability of Three Mometasone Furoate 0.1% Topical Lotions

Padagis

Status: Completed

Conditions: Healthy

Treatments: Drug: Mometasone Furoate 0.1% Topical Lotion-Test product 1; Drug: Mometasone Furoate 0.1% Topical Lotion-Test Product 2; Drug: Mometasone Furoate 0.1% Topical Lotion-Reference Product

Study type: Observational

Funder types: Industry

Identifiers

NCT00805155

10316908

Details and patient eligibility

About

The purpose of this study was to compare the relative vasoconstrictive effects of two test and one reference Mometasone Furoate 0.1% Topical Lotions in healthy, female subjects.

Enrollment: 80 patients

Sex: Female

Ages: 18 to 50 years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

• Non-tobacco using female subjects, 18 to 50 years of age
• Demonstrated blanching response to Reference Drug
• Body Mass Index (BMI) of 30 or less
• 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

Trial design

80 participants in 3 patient groups

Cohort Group 1

Description:

Subjects number 1 to 20

Treatment:

Drug: Mometasone Furoate 0.1% Topical Lotion-Test product 1

Drug: Mometasone Furoate 0.1% Topical Lotion-Reference Product

Drug: Mometasone Furoate 0.1% Topical Lotion-Test Product 2

Cohort Group 2

Description:

Subjects number 21 to 50

Treatment:

Drug: Mometasone Furoate 0.1% Topical Lotion-Test product 1

Drug: Mometasone Furoate 0.1% Topical Lotion-Reference Product

Drug: Mometasone Furoate 0.1% Topical Lotion-Test Product 2

Cohort Group 3

Description:

Subject Numbers 51 to 80

Treatment:

Drug: Mometasone Furoate 0.1% Topical Lotion-Test product 1

Drug: Mometasone Furoate 0.1% Topical Lotion-Reference Product

Drug: Mometasone Furoate 0.1% Topical Lotion-Test Product 2