MedDataX Logo

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

NCT ID: NCT01138514

Last Updated: 2021-10-13

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

View full results

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Clinical Phase

PHASE3

Total Enrollment

1555 participants

Study Classification

INTERVENTIONAL

Study Start Date

2009-10-31

Study Completion Date

2010-10-31

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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).

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Acne Vulgaris

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Investigators

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Clindamycin 1%/Benzoyl Peroxide 5%

Group Type ACTIVE_COMPARATOR

Clindamycin 1% / Benzoyl Peroxide 5% (Perrigo)

Intervention Type DRUG

Applied to the entire face twice daily for 10 weeks

Reference Product

Group Type ACTIVE_COMPARATOR

Clindamycin 1% / Benzoyl Peroxide 5% (Benzaclin)

Intervention Type DRUG

Applied to the entire face twice daily for 10 weeks

Vehicle

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type DRUG

Placebo

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

Clindamycin 1% / Benzoyl Peroxide 5% (Perrigo)

Applied to the entire face twice daily for 10 weeks

Intervention Type DRUG

Clindamycin 1% / Benzoyl Peroxide 5% (Benzaclin)

Applied to the entire face twice daily for 10 weeks

Intervention Type DRUG

Placebo

Placebo

Intervention Type DRUG

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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
Minimum Eligible Age

12 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

Padagis LLC

INDUSTRY

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Responsibility Role SPONSOR

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

PRG-716

Identifier Type: -

Identifier Source: org_study_id