Evaluate Therapeutic Equivalence and Safety of Two Clindamycin Phosphate and Benzoyl Peroxide Gels in Acne Vulgaris

NCT01788384 | Completed Phase 3

• 1 other identifier: 12-1001
• Study Type: interventional
• Target: 708
• Locations: 0 countries
• Sites: N/A

Brief Summary

Acanya (Clindamycin Phosphate and Benzoyl Peroxide) Gel, 1.2%/2.5% gel marketed by Valeant Pharmaceuticals, North America, is a safe and effective topical therapy used for the treatment of acne vulgaris.

Conditions

Acne Vulgaris

Keywords

acne; Clindamycin Phosphate/Benzoyl Peroxide; Acanya; Mild to severe acne vulgaris

Outcome Measures

Primary Outcomes (1)

• The evaluation of the primary endpoint will be based on the mean percent changes from baseline to week 12 in the inflammatory (papules and pustules) lesion counts and in the non-inflammatory (comedones) lesion counts.

  Week 12

Secondary Outcomes (1)

• The proportion of subjects with a clinical response of "success" at Week 12 using IGA.

  12 Weeks

Other Outcomes (2)

• Analysis of Application Site Reactions

  12 Weeks

• Safety analyses were conducted on the Safety population.

  12 Weeks

Study Arms (3)

Acanya

ACTIVE COMPARATOR

Acanya® (Clindamycin Phosphate and Benzoyl Peroxide) Gel, 1.2%/2.5% gel (Valeant Pharmaceuticals, North America)

Drug: Clindamycin Phosphate and Benzoyl Peroxide Gel, 1.2%/2.5%

Clindamycin Phosphate / Benzoyl Peroxide

EXPERIMENTAL

Clindamycin Phosphate / Benzoyl Peroxide Gel, 1.2%/2.5%

Drug: Clindamycin Phosphate / Benzoyl Peroxide Gel

Vehicle Gel

PLACEBO COMPARATOR

Placebo (Vehicle Gel)of the test product (Watson Laboratories, Inc.)

Drug: Placebo (Vehicle Gel)

Interventions

Clindamycin Phosphate / Benzoyl Peroxide Gel DRUG

Dosage form: topical gel Dosage: One pea-sized amount will be applied onto six areas of the face (chin, left cheek, right cheek, nose, left forehead, right forehead), avoiding the eyes, lips and mucous membranes.

Also known as: Generic

Clindamycin Phosphate / Benzoyl Peroxide

Clindamycin Phosphate and Benzoyl Peroxide Gel, 1.2%/2.5% DRUG

Dosage form: topical gel Dosage: One pea-sized amount will be applied onto six areas of the face (chin, left cheek, right cheek, nose, left forehead, right forehead), avoiding the eyes, lips and mucous membranes.

Also known as: Acanya

Acanya

Placebo (Vehicle Gel) DRUG

Dosage form: topical gel Dosage: One pea-sized amount will be applied onto six areas of the face (chin, left cheek, right cheek, nose, left forehead, right forehead), avoiding the eyes, lips and mucous membranes.

Also known as: Vehicle Gel

Vehicle 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:

• Healthy male or non pregnant female
• ≥ 12 and ≤ 40 years
• Diagnosis of acne vulgaris (acne)
• \>18 years and provide written informed consent
• Ages 12 to 17 and provide written assent and written informed consent from patient's legal representative
• Must sign a HIPAA authorization
• Minimum ≥ 25 non-inflammatory lesions
• ≥ 20 inflammatory lesions
• ≤ 2 nodulocystic lesions on the face
• Acne of severity grade 2, 3, or 4 -Investigator's Global Assessment (IGA)
• Refrain from all other topical acne medications or antibiotics during the 12-week treatment period except Investigational Product
• All Female patients with a negative urine pregnancy test who use birth control from the study start to 30 days after the last administration of study drug
• All male patients who use birth control with their partners, from the study start to 30 days after the last administration of study drug. Abstinence is acceptable. Female partners should use birth control
• Must be willing and able to understand and comply with the protocol requirements and required study visits
• In good health

You may not qualify if:

• Female patients who are pregnant, nursing or planning to become pregnant during study
• History or presence of Crohn's disease, ulcerative colitis, regional enteritis, or antibiotic-associated colitis
• Hypersensitivity or allergy to benzoyl peroxide, clindamycin and/or any of the study medication ingredients
• Presence of any skin condition that would interfere with the diagnosis or assessment
• Excessive facial hair
• Wax epilation of the face within 14 days prior
• Used oral retinoids or therapeutic vitamin A supplements of \>10,000 units/day (multivitamins are allowed) within 6 months prior to or during the study
• Estrogens or oral contraceptives for \<3 months prior to baseline; Use of such therapy must remain constant throughout the study
• Cryodestruction, chemodestruction, dermabrasion, photodynamic therapy, acne surgery, intralesional steroids, X-ray therapy procedures performed on the face within 1 month prior to or during the study
• Any systemic (steroids, antibiotics treatment for acne, anti-inflammatory agents) treatments within 1 month prior to baseline or during the study
• Any (topical steroids, topical retinoids, α-hydroxy/glycolic acid, benzoyl peroxide, topical anti-inflammatory agents, topical antibiotics) treatments within 2 weeks prior to baseline or during the study:
• Intend to use Spironolactone
• Intend to use tanning booths, sunbathing, or excessive exposure to the sun
• Radiation therapy and/or anti-neoplastic agents within 90 days prior to baseline
• Unstable clinically significant medical disorders or life-threatening diseases

Sponsors & Collaborators

• Watson Laboratories, Inc.: lead

MeSH Terms

Conditions

Acne Vulgaris

Interventions

clindamycin phosphate; Drugs, Generic; clindamycin phosphate benzoyl peroxide combination

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Pharmaceutical Preparations

Study Officials

• John L Capicchioni

  Akesis, LLC

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 7, 2013
• First Posted: February 11, 2013
• Study Start: July 1, 2012
• Primary Completion: December 1, 2012
• Study Completion: December 1, 2012
• Last Updated: February 11, 2013

Record last verified: 2013-02