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

Acne Clinical Trial

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02651220
• Other study ID #: 71491705
• Status: Completed
• Phase: Phase 3
• Start date: November 2015
• Est. completion date: October 2016

Study information

• Verified date: June 2020
• Source: Actavis Inc.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 1001
• Est. completion date: October 2016
• Est. primary completion date: April 2016
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 12 Years to 40 Years

Eligibility

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.

Related Conditions & MeSH terms

• Acne

Intervention

Drug:
• Epiduo® Forte Gel
Adapalene and Benzoyl Peroxide Gel, 0.3%/2.5% w/w
• Adapalene and Benzoyl Peroxide Gel
Adapalene and Benzoyl Peroxide Gel, 0.3%/2.5% w/w
• placebo gel
vehicle used as placebo

Locations

Country	Name	City	State
Belize	Site 117	Belize City
Belize	Site 118	Belize City
United States	Site 112	Anaheim	California
United States	Site 102	Arlington Heights	Illinois
United States	Site 101	Brandon	Florida
United States	Site 105	Carmel	Indiana
United States	Site 107	Henderson	Nevada
United States	Site 106	High Point	North Carolina
United States	Site 119	Jacksonville	Florida
United States	Site 110	Long Beach	California
United States	Site 111	Los Angeles	California
United States	Site 103	Mesa	Arizona
United States	Site 114	Miami	Florida
United States	Site 115	Miami	Florida
United States	Site 116	Miramar	Florida
United States	Site 120	New Albany	Indiana
United States	Site 108	Rhinelander	Wisconsin
United States	Site 104	San Diego	California
United States	Site 109	Tucson	Arizona
United States	Site 113	West Covina	California

Sponsors (1)

Lead Sponsor	Collaborator
Actavis Inc.

Countries where clinical trial is conducted

United States,  Belize, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Percent Change From Baseline to Week 12 in the Number of Inflamed Lesions.		12 weeks
Primary	Percent Change From Baseline to Week 12 in the Number of Non-inflamed Lesions.		12 weeks
Secondary	Percentage of Patients With a Clinical Response of "Clinical Success" Using the Investigator's Global Assessment (IGA) at Week 12	The Investigator's Global Assessment had to show a score of 0 (clear) or 1 (almost clear) to be considered a "Clinical Success".; 0= Clear skin with no inflammatory or non inflammatory lesions.; Almost clear, rare non-inflammatory lesions with no more than one small inflammatory lesion.; Mild severity; greater than Grade 1; some non inflammatory lesions with no more than a few inflammatory lesions (papules/pustules only, no nodular lesions).; Moderate severity; greater than Grade 2; up to many non inflammatory lesions and may have some inflammatory lesions, but no more than one small nodular lesion.; Severe; greater than Grade 3, up to many non inflammatory lesions and may have some inflammatory lesions, but no more than a few nodular lesions.; Very severe, greater than Grade 4	12 weeks