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

Acne Vulgaris Clinical Trial

Official title:

A Multi-Center, Double-Blind, Randomized, Vehicle-Controlled, Parallel-Group Study to Compare Perrigo Israel Pharmaceuticals, Ltd., Clindamycin 1%/Benzoyl Peroxide 5% Topical Gel to a Comparator Clindamycin / Benzoyl Peroxide Topical Gel, and Both Active Treatments to a Vehicle Control in the Treatment of Acne Vulgaris

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01138514
• Other study ID #: PRG-716
• Status: Completed
• Phase: Phase 3
• Start date: October 2009
• Est. completion date: October 2010

Study information

• Verified date: October 2021
• Source: Padagis LLC
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

The purpose of this study is to compare the efficacy and safety profiles of Perrigo Israel Pharmaceuticals, Ltd. Clindamycin 1%/Benzoyl Peroxide 5% Topical Gel and Benzaclin® Topical Gel (Clindamycin- Benzoyl Peroxide Gel).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 1555
• Est. completion date: October 2010
• Est. primary completion date: October 2010
• Accepts healthy volunteers: No
• Gender: All
• Age group: 12 Years to 65 Years

Eligibility

Inclusion Criteria:

• Healthy men or women, 12 to 65 years of age

• Willing to participate and sign provide written consent

• Moderate to severe acne

Exclusion Criteria:

• Pregnant or lactating women

• History of unresponsiveness or hypersensitivity to clindamycin, benzoyl peroxide or lincomycin

• Use of systemic, topical or facial products which may interfere with the study

• Participation in any clinical study in the 30 days prior to study entry

• Prolonged exposure to sunlight or excessive exposure to UV lights

• Chronic use of NSAIDS

Related Conditions & MeSH terms

• Acne Vulgaris

Intervention

Drug:
• Clindamycin 1% / Benzoyl Peroxide 5% (Perrigo)
Applied to the entire face twice daily for 10 weeks
• Clindamycin 1% / Benzoyl Peroxide 5% (Benzaclin)
Applied to the entire face twice daily for 10 weeks
• Placebo
Placebo

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Padagis LLC

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Percent Change From Baseline in Inflammatory Lesions		10 weeks
Primary	Percent Change From Baseline in Non-inflammatory Lesions		10 weeks
Secondary	Number of Participant With Clinical Success on the Investigator's Global Assessment (IGA)	Clinical success was defined as a score of clear (0) or almost clear (1) at Week 10.	10 weeks