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

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ClinicalTrials.gov Identifier: NCT02651220
Recruitment Status : Completed
First Posted : January 8, 2016
Last Update Posted : November 25, 2016
Sponsor:
Information provided by (Responsible Party):
Actavis Inc.

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

Condition or disease Intervention/treatment Phase
Acne Drug: Epiduo® Forte Gel Drug: Adapalene and Benzoyl Peroxide Gel Drug: placebo gel Phase 3

Detailed Description:

Up to 1000 patients 12 to 40 years of age inclusive will be enrolled to have 870 patients in the modified intent-to-treat (mITT) population and 579 patients in the per-protocol (PP) population. The primary inclusion criteria are the presence of ≥ 20 inflammatory lesions (papules and pustules) and ≥ 25 non-inflammatory lesions (opened and closed comedones) and ≤ 2 nodulocystic lesions (i.e., nodules and cysts) on the face and an Investigator's Global Assessment (IGA) score of 3 or 4.

Eligible patients will be randomized in a 1:1:1 ratio to one of the three treatments (Test, Reference or Placebo) on Visit 1. Patients will be instructed to apply the first treatment on the evening of enrollment into the study and then continue to apply once daily for the next 83 days (for a total 84 days). Patients will attend the following scheduled clinic visits:

  • Visit 1 - Screening/Baseline: Day 1
  • Visit 2 - Interim Visit: Day 28 ± 4
  • Visit 3 - Interim Visit: Day 56 ± 4
  • Visit 4 - End of Study: Day 85 ± 4 Efficacy evaluations will be based on dermatological assessments in the clinic. The primary statistical analyses of interest are (1) the percent change from baseline to Week 12 in the number of inflamed (papules/pustules) lesions and non-inflamed (open and closed comedones) lesions. In addition, patients will also be evaluated by the Investigator to determine "Clinical Success" or "Clinical Failure" at Week 12

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 1000 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Study Start Date : November 2015
Actual Primary Completion Date : April 2016
Actual Study Completion Date : October 2016

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Acne

Arm Intervention/treatment
Experimental: Adapalene and Benzoyl Peroxide Gel, 0.3%/2.5% w/w Drug: Adapalene and Benzoyl Peroxide Gel
Adapalene and Benzoyl Peroxide Gel, 0.3%/2.5% w/w

Active Comparator: Epiduo® Forte Gel 0.3%/2.5% w/w Drug: Epiduo® Forte Gel
Adapalene and Benzoyl Peroxide Gel, 0.3%/2.5% w/w

Placebo Comparator: Placebo (vehicle) Topical Gel Drug: placebo gel
vehicle used as placebo




Primary Outcome Measures :
  1. mean percent change from baseline to Week 12 in the number of inflamed and non-inflamed lesions. [ Time Frame: baseline and 3 months ]

Secondary Outcome Measures :
  1. proportion of patients with a clinical response of "Clinical Success" using the Investigator's Global Assessment (IGA) at Week 12 [ Time Frame: 3 months ]


Information from the National Library of Medicine

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Ages Eligible for Study:   12 Years to 40 Years   (Child, Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  1. Male or non-pregnant, non-lactating female, ≥ 12 and ≤ 40 years of age with a clinical diagnosis of acne vulgaris.
  2. 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.
  3. 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.
  4. 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).
  5. Have an Investigator's Global Assessment (IGA) score of 3 or 4 (see Appendix A).
  6. 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.
  7. 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.

Exclusion Criteria:

  1. 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.
  2. Patient has active cystic acne.
  3. Patient has acne conglobata, acne fulminans, or acne vulgaris requiring systemic treatment.
  4. 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).
  5. Patients with excessive facial hair such as beards, sideburns, moustaches, etc. that would interfere with the diagnosis or assessment of acne.
  6. Patients with tattoos or excessive facial scarring that, in the Investigator's opinion, may interfere with the evaluation of the patient's acne.
  7. Patients with active facial sunburn, peeling from sunburn, or patients that will be exposed to excessive sunlight during the study.
  8. Females who are pregnant, lactating or likely to become pregnant during the study.
  9. 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.
  10. 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.
  11. Use of the following on the face within 1 month before Screening/Baseline:

    • Cryodestruction or chemodestruction
    • Dermabrasion
    • Photodynamic therapy
    • Acne surgery
    • Intralesional steroids
    • X-ray therapy
  12. Use of the following within 1 month before Screening/Baseline:

    • Spironolactone
    • Systemic steroids
    • Systemic antibiotics
    • Systemic anti-inflammatory agents (the use of acetylsalicylic acid for prophylactic use up to 325 mg/day is allowed, provided that the patient is on a stable dose and the regimen will remain constant throughout the study). Acetaminophen will be allowed during the study with a maximum dose of 1g (i.e., 1000 mg) twice daily and for a maximum of 3 consecutive days (its use is not allowed within 1 week of each visit).
    • Systemic treatment for acne vulgaris (other than oral retinoids that require a 6 month washout), including anti-androgens.
  13. Use of oral isotretinoin (Accutane®) or oral retinoids within 6 months, or therapeutic vitamin A supplements greater than 10,000 units/day (multivitamins are allowed).
  14. Use of the following on the face within 2 weeks before Screening/Baseline:

    • Topical steroids
    • Topical retinoids
    • Topical zinc
    • Topical anti-inflammatory agents (including salicylic acid)
    • Topical antibiotics (including antibacterials)
    • Benzoyl peroxide
    • Any other topical over-the-counter preparations for acne treatment
  15. Use of the following on the face within 1 week before Screening/Baseline:

    • Phototherapy devices for acne (e.g., ClearLightTM)
    • Medicated cleansers including adhesive cleansing strips
    • Cosmetic procedures (i.e., facials, peeling, comedone extraction) and alpha-hydroxy/glycolic acid
  16. Receipt of any drug as part of a research study within 30 days.
  17. Female patients taking hormonal contraceptives or oral estrogen for less than three months and those that plan to change the dosage regimen during the course of the study.
  18. Previous participation in this study.
  19. Employees of the Investigator or research center or their immediate family members.
  20. Patients who are illiterate.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02651220


Locations
United States, Arizona
Site 103
Mesa, Arizona, United States, 85202
Site 109
Tucson, Arizona, United States, 85712
United States, California
Site 112
Anaheim, California, United States, 92804
Site 110
Long Beach, California, United States, 90813
Site 111
Los Angeles, California, United States, 92210
Site 104
San Diego, California, United States, 92108
Site 113
West Covina, California, United States, 91790
United States, Florida
Site 101
Brandon, Florida, United States, 33511
Site 119
Jacksonville, Florida, United States, 32256
Site 114
Miami, Florida, United States, 33015
Site 115
Miami, Florida, United States, 33175
Site 116
Miramar, Florida, United States, 33027
United States, Illinois
Site 102
Arlington Heights, Illinois, United States, 60005
United States, Indiana
Site 105
Carmel, Indiana, United States, 46032
Site 120
New Albany, Indiana, United States, 47150
United States, Nevada
Site 107
Henderson, Nevada, United States, 89052
United States, North Carolina
Site 106
High Point, North Carolina, United States, 27262
United States, Wisconsin
Site 108
Rhinelander, Wisconsin, United States, 54501
Belize
Site 117
Belize City, Belize
Site 118
Belize City, Belize
Sponsors and Collaborators
Actavis Inc.

Responsible Party: Actavis Inc.
ClinicalTrials.gov Identifier: NCT02651220     History of Changes
Other Study ID Numbers: 71491705
First Posted: January 8, 2016    Key Record Dates
Last Update Posted: November 25, 2016
Last Verified: November 2016
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Additional relevant MeSH terms:
Benzoyl Peroxide
Adapalene
Adapalene, Benzoyl Peroxide Drug Combination
Dermatologic Agents
Anti-Inflammatory Agents, Non-Steroidal
Analgesics, Non-Narcotic
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Anti-Inflammatory Agents
Antirheumatic Agents