Status and phase
Conditions
Treatments
About
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
Full 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:
Enrollment
Sex
Ages
Volunteers
Inclusion criteria
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:
Female patients of childbearing potential are defined as:
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.
Exclusion criteria
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:
Use of the following within 1 month before Screening/Baseline:
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).
Use of the following on the face within 2 weeks before Screening/Baseline:
Use of the following on the face within 1 week before Screening/Baseline:
Receipt of any drug as part of a research study within 30 days.
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.
Previous participation in this study.
Employees of the Investigator or research center or their immediate family members.
Patients who are illiterate.
Primary purpose
Allocation
Interventional model
Masking
1,001 participants in 3 patient groups, including a placebo group
Loading...
Data sourced from clinicaltrials.gov
Clinical trials
Research sites
Resources
Legal