Double-blind Placebo-controlled Trial of Generic Clindamycin/Benzoyl Peroxide Gel Versus Onexton Gel in Acne Vulgaris

NCT02616614 | Completed Phase 3 Results

• 1 other identifier: WAT/CMBP/2015
• Study Type: interventional
• Target: 862
• Locations: 1 country
• Sites: 17

Brief Summary

Actavis has developed a generic formulation of clindamycin 1.2% and benzoyl peroxide 3.75% gel. This study is designed to evaluate the safety and efficacy of this formulation in subjects with Acne Vulgaris

Conditions

Acne Vulgaris

Outcome Measures

Primary Outcomes (2)

• Percent Change in the Inflammatory (Papules and Pustules) Lesion Counts

  Percent change from baseline to Week 12 (Day 84) in the inflammatory (papules and pustules) lesion count in PP Population.

  12 weeks

• Percent Change in the Non-Inflammatory (Open and Closed Comedomes) Lesion Counts

  One of the co-primary endpoints was the percent change from baseline to Week 12 (Day 84) in the non-inflammatory (open and closed comedones) lesion counts in PP Population.

  12 weeks

Secondary Outcomes (1)

• Number of Subjects With Treatment Success at Week 12

  12 weeks

Study Arms (3)

Onexton gel

ACTIVE COMPARATOR

Clindamycin 1.2% and benzoyl peroxide 3.75% topical gel Applied a thin film of medication onto 6 areas of the face (chin, left cheek, right cheek, nose, left forehead, and right forehead) once daily

Drug: Onexton

Clindamycin/benzoyl peroxide gel

EXPERIMENTAL

Generic clindamycin 1.2% and benzoyl peroxide 3.75% topical gel. Applied a thin film of medication onto 6 areas of the face (chin, left cheek, right cheek, nose, left forehead, and right forehead) once daily

Drug: Clindamycin/benzoyl peroxide gel

Placebo

PLACEBO COMPARATOR

A vehicle gel. Applied a thin film of medication onto 6 areas of the face (chin, left cheek, right cheek, nose, left forehead, and right forehead) once daily

Drug: Placebo

Interventions

Onexton DRUG

Topical gel for treating acne

Also known as: Clindamycin/benzoyl peroxide gel

Onexton gel

Clindamycin/benzoyl peroxide gel DRUG

Generic Clindamycin/benzoyl peroxide gel for treating acne

Also known as: Clindamcyin Phosphate, BPO

Clindamycin/benzoyl peroxide gel

Placebo DRUG

Vehicle gel used as a placebo

Also known as: Vehicle

Placebo

Eligibility Criteria

• Age: 12 Years - 40 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• Healthy male or non-pregnant female aged ≥ 12 and ≤ 40 years with a clinical diagnosis of acne vulgaris
• On the face, ≥25 non-inflammatory lesions (i.e., open and closed comedones) and ≥ 20 inflammatory lesions (i.e., papules and pustules) and ≤ 2 nodulocystic lesions (i.e., nodules and cysts). For the purposes of study treatment and evaluation, these lesions should be limited to the facial treatment area. Counts of nodules and cysts should be reported separately and not included in the inflammatory or non-inflammatory lesion counts. Lesions involving the eyes and scalp should be excluded from the count. (Subjects may have acne lesions on other areas of the body (e.g., on the back)).
• Subjects must have Investigator's Global Assessment (IGA) of acne severity grade 2, 3, or 4.
• Willing to refrain from use of all other topical acne medications or antibiotics during the 12 week treatment period. Subjects may use other topical acne treatments that do not have significant or measurable systemic absorption for treatment of acne of the back, shoulders and chest (e.g. benzoyl peroxide, salicylic acid).
• Subjects who are 18 years of age or older must have provided Institutional Review Board (IRB) approved written informed consent. Subjects who are at least 12 years of age and less than 18 years of age must have provided IRB approved written assent; this written assent must be accompanied by an IRB approved written informed consent from the subject's legally acceptable representative (i.e., parent or guardian). In addition, all subjects or their legally acceptable representatives (i.e., parent or guardian) must sign a Health Insurance Portability and Accountability Act (HIPAA) authorization, if applicable.
• Male subjects and Female subjects of childbearing potential must use accepted methods of birth control or must agree to practice abstinence, from study start to 30 days after the last administration of study drug. All female subjects are considered to be of childbearing potential unless they have been surgically sterilized or have been postmenopausal for at least 1 year. Any of the following methods of birth control are acceptable: oral contraceptives, contraceptive patches/implants (e.g., Norplant®), vaginal ring (NuvaRing®), Depo-Provera® (Medroxy progesterone acetate), double barrier methods (e.g., condom and spermicide) or intrauterine device (IUD).
• Female subjects of child bearing potential must have a negative urine pregnancy test at baseline.
• Subjects who use make-up must have used the same brands/types of make-up for a minimum period of 14 days prior to study entry and must agree to not change make-up brand/type or frequency of use throughout the study.

You may not qualify if:

• History of hypersensitivity or allergy to clindamycin or benzoyl peroxide and/or any of the study medication ingredients or lincomycin or any other allowed product used during the study.
• Presence of any skin condition that would interfere with the diagnosis or assessment of acne vulgaris (e.g., on the face: rosacea, dermatitis, psoriasis, squamous cell carcinoma, eczema, acneform eruptions caused by medications, steroid acne, steroid folliculitis, or bacterial folliculitis).
• Excessive facial hair (beards, sideburns, moustaches, etc.) that would interfere with diagnosis or assessment of acne vulgaris. Patient is allowed to shave the excessive facial hair at least a day before visiting the site for study assessments.
• Use within 6 months prior to baseline of oral retinoids (e.g. Accutane®) or therapeutic vitamin A supplements of greater than 10,000 units/day.
• Use for less than 3 months prior to baseline of estrogens or oral contraceptives; use of such therapy must remain constant throughout the study.
• Use on the face within 1 month prior to baseline or during the study of: 1) cryodestruction, 2) dermabrasion, 3) photodynamic therapy, 4) acne surgery, 5) intralesional steroids, or 6) x-ray therapy.
• Use within 1 month prior to baseline of: 1) spironolactone, 2) systemic steroids, 3) systemic antibiotics, 4) systemic treatment for acne vulgaris or 5) systemic anti-inflammatory agents.
• Use within 2 weeks prior to baseline of: 1) topical steroids, 2) topical retinoids, 3) topical acne treatments including over-the-counter preparations, 4) topical anti- inflammatory agents, 5) medicated cleansers or 6) topical antibiotics.
• Subjects who have acne fulminans, and secondary acne (e.g., chloracne and drug induced acne) will be excluded from participation.
• Female subjects who are pregnant, nursing or planning to become pregnant during study participation (Visit 1 through Visit 4 and 30 days post visit 4) will be excluded from study participation.
• Subjects who have received radiation therapy and/or anti-neoplastic agents within 90 days prior to baseline will be excluded from study participation.
• Subjects who have unstable medical disorders that are clinically significant or life-threatening diseases will be excluded from study participation.
• Subjects who have on-going malignancies requiring systemic treatment will be excluded from study participation. In addition, subjects who have any malignancy of the skin of the facial area will be excluded from study participation.
• Subjects who engage in activities that involve excessive or prolonged exposure to sunlight or weather extremes, such as wind or cold, will be excluded from study participation.
• Subjects who have facial sunburn will be excluded from study participation

Sponsors & Collaborators

• Actavis Inc.: lead

Study Sites (17)

Alliance Dermatology

Phoenix, Arizona, 85032, United States

Location

Estudy

Chula Vista, California, 91911, United States

Location

Estudy

La Mesa, California, 91942, United States

Location

Tampa Bay Medical Research

Clearwater, Florida, 33761, United States

Location

AMB Research Center

Miami, Florida, 33144, United States

Location

Meridian Clinical Research

Savannah, Georgia, 31406, United States

Location

Heartland Research Assoc

Augusta, Kansas, 67010, United States

Location

Heartland Research Assoc

Wichita, Kansas, 67207, United States

Location

Sundance Clinical Research

St Louis, Missouri, 63141, United States

Location

Meridian Clinical Research

Norfolk, Nebraska, 68701, United States

Location

Meridian Clinical Research

Omaha, Nebraska, 68134, United States

Location

Dermatology Consulting Services

High Point, North Carolina, 27262, United States

Location

Sterling Research Group

Cincinnati, Ohio, 45246, United States

Location

Discover Research

Beaumont, Texas, 77701, United States

Location

DiscoverResearch Inc

Bryan, Texas, 77802, United States

Location

Reseacr Across America

Dallas, Texas, 75234, United States

Location

Clinical Research Assoc. of Tidewater

Norfolk, Virginia, 23507, United States

Location

MeSH Terms

Conditions

Acne Vulgaris

Interventions

clindamycin phosphate benzoyl peroxide combination; Clindamycin

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

Results Point of Contact

• Title: Senior Director, CE Studies
• Organization: Teva Pharmaceuticals USA, Inc.

USMedInfo@tevapharm.com

1-888-483-8279

Study Officials

• Henry lau, PhD

  Actavis Inc.

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

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: November 25, 2015
• First Posted: November 30, 2015
• Study Start: May 1, 2015
• Primary Completion: October 1, 2015
• Study Completion: November 1, 2015
• Last Updated: May 27, 2020
• Results First Posted: May 27, 2020

Record last verified: 2020-05

Locations

US (17)