Clinical End Point Study of Generic Adapalene and Benzoyl Peroxide Gel Versus Epiduo® Forte Gel in Treatment of Acne Vulgaris

NCT02651220 | Completed Phase 3 Results

• 1 other identifier: 71491705
• Study Type: interventional
• Target: 1,001
• Locations: 2 countries
• Sites: 20

Brief Summary

A Randomized, Double-Blind, Placebo-Controlled, Parallel-Design, Multiple-Site Clinical Study to Evaluate the Therapeutic Equivalence and Safety of adapalene and benzoyl peroxide gel, 0.3%/2.5% (Actavis Laboratories UT, Inc.) to Epiduo® Forte (adapalene and benzoyl peroxide) gel 0.3%/2.5% (Galderma) in the treatment of Acne Vulgaris

Conditions

Acne

Outcome Measures

Primary Outcomes (2)

• Percent Change From Baseline to Week 12 in the Number of Inflamed Lesions.

  12 weeks

• Percent Change From Baseline to Week 12 in the Number of Non-inflamed Lesions.

  12 weeks

Secondary Outcomes (1)

• Percentage of Patients With a Clinical Response of "Clinical Success" Using the Investigator's Global Assessment (IGA) at Week 12

  12 weeks

Study Arms (3)

Adapalene and Benzoyl Peroxide Gel, 0.3%/2.5% w/w

EXPERIMENTAL

Drug: Adapalene and Benzoyl Peroxide Gel

Epiduo® Forte Gel 0.3%/2.5% w/w

ACTIVE COMPARATOR

Drug: Epiduo® Forte Gel

Placebo (vehicle) Topical Gel

PLACEBO COMPARATOR

Drug: placebo gel

Interventions

Epiduo® Forte Gel DRUG

Adapalene and Benzoyl Peroxide Gel, 0.3%/2.5% w/w

Epiduo® Forte Gel 0.3%/2.5% w/w

Adapalene and Benzoyl Peroxide Gel DRUG

Adapalene and Benzoyl Peroxide Gel, 0.3%/2.5% w/w

Adapalene and Benzoyl Peroxide Gel, 0.3%/2.5% w/w

placebo gel DRUG

vehicle used as placebo

Placebo (vehicle) Topical Gel

Eligibility Criteria

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

You may qualify if:

• Male or non-pregnant, non-lactating female, ≥ 12 and ≤ 40 years of age with a clinical diagnosis of acne vulgaris.
• Signed informed consent form that meets all criteria of current FDA regulations. For a patient considered to be a minor in the state he/she lives and is enrolled, the patient parent or legal guardian will be required to sign the consent form and the patient will sign an IRB approved "assent to participate" form.
• Females of child bearing potential must not be pregnant or lactating at Visit 1 (as confirmed by a negative urine pregnancy test with a sensitivity of less than 25 mlU/mL or equivalent units of human chorionic gonadotropin). Women of childbearing potential must agree to the use of a reliable method of contraception (e.g., total abstinence, IUD, a double-barrier method \[such as condom plus diaphragm with spermicide\], oral, transdermal, injected or implanted non- or hormonal contraceptive), throughout the study. If the female is using a hormonal contraceptive, the same product must be taken for 3 months prior to Visit 1 and must agree not to replace with some other hormonal contraceptives during the study. A sterile sexual partner is not considered an adequate form of birth control.
• All females will be considered to be of childbearing potential unless they:
• Are post-menopausal, defined as women who have been amenorrheic for at least 12 consecutive months, without other known or suspected primary cause.
• Have been sterilized surgically or who are otherwise proven sterile (i.e., total hysterectomy, or bilateral oophorectomy) with surgery at least 4 weeks prior to Screening. Tubal ligation will not be considered a surgically sterile method.
• Female patients of childbearing potential are defined as:
• Females without prior hysterectomy, or who have had any evidence of menses in the past 12 months.
• Females who have been amenorrhea for ≥ 12 months, but the amenorrhea is possibly due to other causes, including prior chemotherapy, anti-estrogens, or ovarian suppression.
• Have facial acne vulgaris with: ≥ 20 inflammatory lesions (i.e., papules and pustules) and ≥ 25 non-inflammatory lesions (i.e., open and closed comedones) and ≤ 2 nodulocystic lesions (i.e., nodules and cysts).
• Have an Investigator's Global Assessment (IGA) score of 3 or 4 (see Appendix A).
• Willing to comply with the study requirements and restrictions including refraining from the use of all other topical acne medications or antibiotics during the 12 week treatment period.
• Patients who use make-up must have used the same brands/types for a minimum period of 14 days before study entry and must agree to not change brand/type or frequency of use throughout the study.

You may not qualify if:

• Patient has more than 2 facial nodular lesions; any nodules present will be documented but not included in the inflammatory and non-inflammatory lesion count for analysis.
• Patient has active cystic acne.
• Patient has acne conglobata, acne fulminans, or acne vulgaris requiring systemic treatment.
• Patient has a 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, bacterial folliculitis).
• Patients with excessive facial hair such as beards, sideburns, moustaches, etc. that would interfere with the diagnosis or assessment of acne.
• Patients with tattoos or excessive facial scarring that, in the Investigator's opinion, may interfere with the evaluation of the patient's acne.
• Patients with active facial sunburn, peeling from sunburn, or patients that will be exposed to excessive sunlight during the study.
• Females who are pregnant, lactating or likely to become pregnant during the study.
• History of allergy or hypersensitivity to adapalene, retinoids, benzoyl peroxide or history of any drug hypersensitivity or intolerance that, in the Investigator's opinion, would compromise the safety of the patient or the study.
• Significant history or current evidence of chronic infectious disease, system disorder, organ disorder or other medical condition that, in the Investigator's opinion, would place the study participant at undue risk by participation.
• Use of the following on the face within 1 month before Screening/Baseline:
• Cryodestruction or chemodestruction
• Dermabrasion
• Photodynamic therapy
• Acne surgery

Sponsors & Collaborators

• Actavis Inc.: lead

Study Sites (20)

Site 103

Mesa, Arizona, 85202, United States

Location

Site 109

Tucson, Arizona, 85712, United States

Location

Site 112

Anaheim, California, 92804, United States

Location

Site 110

Long Beach, California, 90813, United States

Location

Site 111

Los Angeles, California, 92210, United States

Location

Site 104

San Diego, California, 92108, United States

Location

Site 113

West Covina, California, 91790, United States

Location

Site 101

Brandon, Florida, 33511, United States

Location

Site 119

Jacksonville, Florida, 32256, United States

Location

Site 114

Miami, Florida, 33015, United States

Location

Site 115

Miami, Florida, 33175, United States

Location

Site 116

Miramar, Florida, 33027, United States

Location

Site 102

Arlington Heights, Illinois, 60005, United States

Location

Site 105

Carmel, Indiana, 46032, United States

Location

Site 120

New Albany, Indiana, 47150, United States

Location

Site 107

Henderson, Nevada, 89052, United States

Location

Site 106

High Point, North Carolina, 27262, United States

Location

Site 108

Rhinelander, Wisconsin, 54501, United States

Location

Site 117

Belize City, Belize

Location

Site 118

Belize City, Belize

Location

MeSH Terms

Conditions

Acne Vulgaris

Interventions

Adapalene

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Naphthalenes; Polycyclic Aromatic Hydrocarbons; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals; Polycyclic Compounds

Results Point of Contact

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

USMedInfo@tevapharm.com

1-888-483-8279

Publication Agreements

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

Study Design

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

Study Record Dates

• First Submitted: January 5, 2016
• First Posted: January 8, 2016
• Study Start: November 1, 2015
• Primary Completion: April 1, 2016
• Study Completion: October 1, 2016
• Last Updated: June 23, 2020
• Results First Posted: June 23, 2020

Record last verified: 2020-06

Data Sharing

• IPD Sharing: Will not share

Locations

US (18); BE (2)