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

NCT ID: NCT01044264

Last Updated: 2023-07-12

Study Results

Results available

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

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

602 participants

Study Classification

INTERVENTIONAL

Study Start Date

2007-12-31

Study Completion Date

2008-09-30

Brief Summary

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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.

Detailed Description

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Conditions

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Acne Vulgaris

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

TRIPLE

Participants Caregivers Investigators

Study Groups

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1% Clindamycin/5% Benzoyl Peroxide Topical Gel

Test product

Group Type ACTIVE_COMPARATOR

1% Clindamycin/5% Benzoyl Peroxide Topical Gel

Intervention Type DRUG

Topical Gel

DUAC® 1% Clindamycin/5% Benzoyl Peroxide Topical Gel

Reference product

Group Type ACTIVE_COMPARATOR

1% Clindamycin/5% Benzoyl Peroxide Topical Gel

Intervention Type DRUG

Topical Gel

Placebo

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type DRUG

Placebo

Interventions

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1% Clindamycin/5% Benzoyl Peroxide Topical Gel

Topical Gel

Intervention Type DRUG

Placebo

Placebo

Intervention Type DRUG

Other Intervention Names

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DUAC® 1% Clindamycin/5% Benzoyl Peroxide Topical Gel

Eligibility Criteria

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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
Minimum Eligible Age

12 Years

Maximum Eligible Age

40 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Padagis LLC

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Other Identifiers

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DAC-501-601-727998

Identifier Type: -

Identifier Source: org_study_id

NCT00807638

Identifier Type: -

Identifier Source: nct_alias

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