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

NCT01769664 | Completed Phase 1

• 1 other identifier: CLBG 1209
• Study Type: interventional
• Target: 650
• Locations: 0 countries
• Sites: N/A

Brief Summary

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.

Conditions

Acne Vulgaris

Keywords

Acne vulgaris; Clindamycin 1%/Benzoyl Peroxide 5% Topical Gel; Duac® Topical Gel

Outcome Measures

Primary Outcomes (1)

• Bioequivalence of test gel to reference gel

  Bioequivalence will be determined by evaluating the mean percent change from baseline to week 11 in the number of inflammatory lesions.

  Week 11 (study day 77)

Secondary Outcomes (1)

• Superiority against placebo

  Week 11 (study day 77)

Study Arms (3)

Clindamycin 1%/Benzoyl Peroxide 5% Topical Gel

EXPERIMENTAL

Clindamycin 1%/Benzoyl Peroxide 5% Topical Gel (Taro Pharmaceuticals Inc.)

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

Duac® Topical Gel

ACTIVE COMPARATOR

Duac® (Clindamycin 1%/Benzoyl Peroxide 5%) Topical Gel (Stiefel)

Drug: Duac® Topical Gel

Placebo Topical Gel

PLACEBO COMPARATOR

Placebo (Vehicle) Topical Gel (Taro Pharmaceuticals Inc.)

Drug: Placebo Topical Gel

Interventions

Clindamycin 1%/Benzoyl Peroxide 5% Topical Gel DRUG

Clindamycin 1%/Benzoyl Peroxide 5% Topical Gel (Taro Pharmaceuticals Inc.) applied once a day in the evening for 77 days (11 weeks)

Clindamycin 1%/Benzoyl Peroxide 5% Topical Gel

Duac® Topical Gel DRUG

Duac® (Clindamycin 1%/Benzoyl Peroxide 5%) Topical Gel (Stiefel) applied once a day in the evening for 77 days (11 weeks)

Duac® Topical Gel

Placebo Topical Gel DRUG

Placebo (Vehicle) Topical Gel (Taro Pharmaceuticals Inc.) applied once a day in the evening for 77 days (11 weeks)

Placebo Topical Gel

Eligibility Criteria

• Age: 12 Years - 40 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Sun Pharmaceutical Industries, Inc.: lead

MeSH Terms

Conditions

Acne Vulgaris

Interventions

Clindamycin; Benzoyl Peroxide; Gels

Condition Hierarchy (Ancestors)

Acneiform Eruptions; Skin Diseases; Skin and Connective Tissue Diseases; Sebaceous Gland Diseases

Intervention Hierarchy (Ancestors)

Lincomycin; Lincosamides; Pyrrolidines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Glycosides; Carbohydrates; Benzoates; Acids, Carbocyclic; Carboxylic Acids; Organic Chemicals; Benzene Derivatives; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Colloids; Complex Mixtures; Dosage Forms; Pharmaceutical Preparations

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 11, 2012
• First Posted: January 17, 2013
• Study Start: September 1, 2012
• Primary Completion: June 1, 2013
• Study Completion: August 1, 2013
• Last Updated: January 22, 2014

Record last verified: 2014-01