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Clinical Study Between Two 1% Clindamycin/5% Benzoyl Peroxide Topical Gel Formulations

Information source: Perrigo Company
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Acne Vulgaris

Intervention: 1% Clindamycin/5% Benzoyl Peroxide Topical Gel (Drug); Placebo (Drug)

Phase: N/A

Status: Completed

Sponsored by: Perrigo Company

Summary

A randomized, double-blind, multiple-site, placebo-controlled, parallel-group clinical study conducted to evaluate the bioequivalence of two 1% Clindamycin/5% Benzoyl Peroxide Topical Gel formulations.

Clinical Details

Official title: A Randomized, Double-Blind, Multiple-Site, Placebo-Controlled Study Comparing Two 1% Clindamycin/5% Benzoyl Peroxide Topical Gel Formulations in the Treatment of Moderate to Severe Acne Vulgaris

Study design: Allocation: Randomized, Endpoint Classification: Bio-equivalence Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator), Primary Purpose: Treatment

Primary outcome: Reduction of Inflammatory Lesions

Eligibility

Minimum age: 12 Years. Maximum age: N/A. Gender(s): Both.

Criteria:

Inclusion Criteria:

- healthy men or women, 12 years of age and older

- willing to participate and sign a copy of the informed consent form

- moderate to severe facial acne

Exclusion Criteria:

- history of allergy or hypersensitivity to clindamycin or benzoyl peroxide

- pregnant or lactating women

- evidence of a clinically significant disorder

- receipt of any drugs as part of a research study within 30 days prior to study dosing

- use of systemic, topical or facial products which may interfere with study

- significant facial hair, tattoos, excessive facial scarring, active facial sunburn,

or peeling due to sunburn

Locations and Contacts

Additional Information

Starting date: December 2007
Last updated: January 17, 2013

Page last updated: August 23, 2015

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