ClinicalTrials.Veeva

Menu

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

P

Padagis

Status

Completed

Conditions

Acne Vulgaris

Treatments

Drug: 1% Clindamycin/5% Benzoyl Peroxide Topical Gel
Drug: Placebo

Study type

Interventional

Funder types

Industry

Identifiers

NCT01044264
DAC-501-601-727998

Details and patient eligibility

About

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.

Enrollment

602 patients

Sex

All

Ages

12 to 40 years old

Volunteers

Accepts Healthy Volunteers

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

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Triple Blind

602 participants in 3 patient groups, including a placebo group

1% Clindamycin/5% Benzoyl Peroxide Topical Gel
Active Comparator group
Description:
Test product
Treatment:
Drug: 1% Clindamycin/5% Benzoyl Peroxide Topical Gel
DUAC® 1% Clindamycin/5% Benzoyl Peroxide Topical Gel
Active Comparator group
Description:
Reference product
Treatment:
Drug: 1% Clindamycin/5% Benzoyl Peroxide Topical Gel
Placebo
Placebo Comparator group
Treatment:
Drug: Placebo

Trial contacts and locations

0

Loading...

Data sourced from clinicaltrials.gov

Clinical trials

Find clinical trialsTrials by location
© Copyright 2025 Veeva Systems