A Study Comparing Clindamycin 1%/Benzoyl Peroxide 5% Topical Gel to Duac® Topical Gel in the Treatment of Acne Vulgaris

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Taro Pharmaceuticals USA
ClinicalTrials.gov Identifier:
NCT01769664
First received: October 11, 2012
Last updated: January 19, 2014
Last verified: January 2014
  Purpose

The objective of this study is to compare the relative efficacy and safety of the test formulation Clindamycin 1%/Benzoyl Peroxide 5% Topical Gel (Taro Pharmaceuticals Inc.) to the marketed formulation Duac® Topical Gel (Clindamycin 1%/Benzoyl Peroxide 5%) (Stiefel) in the treatment of the inflamed lesions of acne vulgaris. Both the test and reference formulations will also be compared to a placebo formulation to test for superiority.


Condition Intervention Phase
Acne Vulgaris
Drug: Clindamycin 1%/Benzoyl Peroxide 5% Topical Gel
Drug: Duac® Topical Gel
Drug: Placebo Topical Gel
Phase 1

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment
Official Title: A Randomized, Double-Blind, Multiple-Site, Placebo-Controlled, Parallel Design Study Comparing Clindamycin 1%/Benzoyl Peroxide 5% Topical Gel (Taro Pharmaceuticals Inc.) to Duac® Topical Gel Clindamycin 1%/Benzoyl Peroxide 5% (Stiefel) in the Treatment of Acne Vulgaris

Resource links provided by NLM:


Further study details as provided by Taro Pharmaceuticals USA:

Primary Outcome Measures:
  • Bioequivalence of test gel to reference gel [ Time Frame: Week 11 (study day 77) ] [ Designated as safety issue: No ]
    Bioequivalence will be determined by evaluating the mean percent change from baseline to week 11 in the number of inflammatory lesions.


Secondary Outcome Measures:
  • Superiority against placebo [ Time Frame: Week 11 (study day 77) ] [ Designated as safety issue: No ]
    The superiority of the test and reference against the placebo will be tested for the mean percent reduction in inflamed lesion count at week 11.


Enrollment: 650
Study Start Date: September 2012
Study Completion Date: August 2013
Primary Completion Date: June 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Clindamycin 1%/Benzoyl Peroxide 5% Topical Gel
Clindamycin 1%/Benzoyl Peroxide 5% Topical Gel (Taro Pharmaceuticals Inc.)
Drug: Clindamycin 1%/Benzoyl Peroxide 5% Topical Gel
Clindamycin 1%/Benzoyl Peroxide 5% Topical Gel (Taro Pharmaceuticals Inc.) applied once a day in the evening for 77 days (11 weeks)
Active Comparator: Duac® Topical Gel
Duac® (Clindamycin 1%/Benzoyl Peroxide 5%) Topical Gel (Stiefel)
Drug: Duac® Topical Gel
Duac® (Clindamycin 1%/Benzoyl Peroxide 5%) Topical Gel (Stiefel) applied once a day in the evening for 77 days (11 weeks)
Placebo Comparator: Placebo Topical Gel
Placebo (Vehicle) Topical Gel (Taro Pharmaceuticals Inc.)
Drug: Placebo Topical Gel
Placebo (Vehicle) Topical Gel (Taro Pharmaceuticals Inc.) applied once a day in the evening for 77 days (11 weeks)

  Eligibility

Ages Eligible for Study:   12 Years to 40 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Male or non-pregnant, non-lactating female, between 12 and 40 years of age with a clinical diagnosis of acne vulgaris.
  • Signed informed consent form. For a minor, the parent or legal guardian will sign the consent form and patient will sign assent to participate form.
  • If female of child-bearing potential, prepare to abstain from sexual intercourse or use a reliable method of contraception during the study. Patients on hormonal contraceptives must have been on the same for three months prior to baseline visit and continue throughout the duration of the study.
  • Have facial acne with 20 or more facial inflammatory lesions and 25 or more non-inflammatory lesions and 2 or less nodulocystic lesions and have an Investigator Global Assessment score of 2, 3 or 4.
  • Willing to comply with the study requirements and restrictions including refraining from the use of all other topical acne medications or antibiotics during the treatment period.

Exclusion Criteria:

  • Patient has more than 2 facial nodular lesions.
  • Patient has active cystic acne.
  • Patient has acne conglobata.
  • Patients with excessive facial hair that would interfere with the diagnosis or assessment of acne.
  • Patients with tatoos or excessive facial scarring that may interfere with the evaluation of the patient's acne.
  • Patients with active facial sunburn, peeling due to sunburn and patients who will be exposed to excessive sunlight during the study.
  • Any skin condition other than acne vulgaris that would interfere with the evaluation of the patient's acne.
  • Females who are pregnant, lactating or likely to become pregnant during the study.
  • Patients with a history of or active colitis other than irritable bowel syndrome.
  • History of allergy or hypersensitivity to Clindamycin, Lincomycin or benzoyl peroxide or history of any drug hypersensitivity or intolerance which would compromise the patient's safety or the study.
  • Significant history or current evidence of chronic infectious disease, system disorder, organ disorder or other medical condition that would place the patient at undue risk by participation.
  • Use on the face within 1 month prior to screening/baseline or during the study of the following: cryodestruction or chemodestruction, dermabrasion, photodynamic therapy, acne surgery, intralesional steroids, x-ray therapy.
  • Use of the following within 1 month prior to screening/baseline: spironolactone, systemic steroids, systemic antibiotics, systemic treatment for acne vulgaris (other than oral retinoids which require a 6 month washout), systemic anti-inflammatory agents.
  • Use of oral isotretinoin (Accutane®) or oral retinoids within 6 months, or therapeutic vitamin A supplements greater than 10,000 units/day.
  • Use within 2 weeks prior to screening/baseline of the following: topical steroids, topical retinoids, topical acne treatments including over-the-counter preparations, topical anti-inflammatory agents, medicated cleansers, topical antibiotics.
  • Receipt of any drug as part of a research study within 30 days.
  • Female patients taking hormonal contraceptives or oral estrogen for less than 3 months and those that plan to change the dosage regimen during the course of the study.
  • Previous participation in this study.
  • Employees of the investigator or research center or their immediate family members.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

No Contacts or Locations Provided
  More Information

No publications provided

Responsible Party: Taro Pharmaceuticals USA
ClinicalTrials.gov Identifier: NCT01769664     History of Changes
Other Study ID Numbers: CLBG 1209
Study First Received: October 11, 2012
Last Updated: January 19, 2014
Health Authority: United States: Food and Drug Administration

Keywords provided by Taro Pharmaceuticals USA:
Acne vulgaris
Clindamycin 1%/Benzoyl Peroxide 5% Topical Gel
Duac® Topical Gel

Additional relevant MeSH terms:
Acne Vulgaris
Acneiform Eruptions
Skin Diseases
Facial Dermatoses
Sebaceous Gland Diseases
Benzoyl Peroxide
Clindamycin
Clindamycin palmitate
Clindamycin phosphate
Dermatologic Agents
Therapeutic Uses
Pharmacologic Actions
Anti-Bacterial Agents
Anti-Infective Agents
Protein Synthesis Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action

ClinicalTrials.gov processed this record on July 31, 2014