The objective of this study is to evaluate the therapeutic equivalence and safety of
Adapalene and Benzoyl Peroxide 0. 1%/2. 5% Gel (Taro Pharmaceuticals Inc.) and Epiduo®
(Adapalene and Benzoyl Peroxide 0. 1%/2. 5% Gel) (Galderma Laboratories, L. P.) in the
treatment of acne vulgaris, and to demonstrate the superiority of the efficacy of the test
and reference products over the vehicle (placebo) control in the treatment of acne vulgaris.
Inclusion Criteria:
- Healthy male or non pregnant female aged ≥ 12 and ≤ 40 years with a clinical
diagnosis of acne vulgaris.
- Subjects who are 18 years of age or older must have provided written informed
consent. Subjects 12 to 17 years of age must have provided written assent, which must
be accompanied by written informed consent from the subject's legally acceptable
representative. All subjects or their legally acceptable representatives must sign a
Health Insurance Portability and Accountability Act authorization.
- Subjects must have a minimum of ≥ 25 non-inflammatory lesions and ≥ 20 inflammatory
lesions and ≤ 2 nodulocystic lesions, at baseline on the face.
- Subjects must have a definite clinical diagnosis of acne vulgaris severity grade 2,
3, or 4 as per the Investigator's Global Assessment (IGA).
- Subjects must be willing to refrain from using all other topical acne medications or
antibiotics for acne vulgaris during the 12-week treatment period, other than the
investigational product.
- Female subjects of childbearing potential (excluding those who are surgically
sterilized or postmenopausal for at least 1 year), in addition to having a negative
urine pregnancy test, must be willing to use an acceptable form of birth control
during the study from the day of the first dose administration to 30 days after the
last administration of study drug.
- All male subjects must agree to use accepted methods of birth control with their
partners, from the day of the first dose administration to 30 days after the last
administration of study drug.
- Subjects must be willing and able to understand and comply with the requirements of
the protocol.
- Subjects must be in good health and free from any clinically significant disease,
including but not limited to, conditions that may interfere with the evaluation of
acne vulgaris.
- Subjects who use make-up must have used the same brands/types for a minimum period of
14 days prior to study entry and must agree to not change brand/type or frequency of
use throughout the study.
Exclusion Criteria:
- Female subjects who are pregnant, nursing or planning to become pregnant during study
participation.
- Subjects with a history of hypersensitivity or allergy to adapalene, retinoids and/or
any of the study medication ingredients, have a known hypersensitivity to adapalene
and benzoyl peroxide and its excipients.
- Subjects with the presence of any skin condition that would interfere with the
diagnosis or assessment of acne vulgaris.
- Subjects with excessive facial hair that would interfere with diagnosis or assessment
of acne vulgaris.
- Subjects who have performed wax depilation of the face within 14 days prior to
baseline.
- Subjects who have used within 6 months prior to baseline or use during the study of
oral retinoids or therapeutic Vitamin A supplements of greater than 10,000 units/day.
- Subjects who have used estrogens or oral contraceptives for less than 3 months prior
to baseline.
- Subjects who have used any of the following procedures on the face within 1 month
prior to baseline or use during the study: cryodestruction or chemodestruction,
dermabrasion, photodynamic therapy, acne surgery, intralesional steroids, x-ray
therapy.
- Subjects who have used any of the following treatments within 1 month prior to
baseline or use during the study: systemic steroids, systemic antibiotics, systemic
treatment for acne vulgaris, systemic anti-inflammatory agents.
- Subjects who have used any of the following treatments within 2 weeks prior to
baseline or during the study: topical steroids, topical retinoids, α-hydroxy/glycolic
acid, benzoyl peroxide, topical anti-inflammatory agents, topical antibiotics.
- Use of spironolactone is prohibited during the study.
- Use of tanning booths, sunbathing, or excessive exposure to the sun are prohibited
during the study.
- Subjects who have received radiation therapy and/or anti-neoplastic agents within 90
days prior to baseline.
- Subjects who have unstable medical disorders that are clinically significant or have
life-threatening diseases.
- Subjects who have on-going malignancies requiring systemic treatment, and subjects
who have any malignancy of the skin of the facial area.
- Subjects who engage in activities that involve excessive or prolonged exposure to
sunlight or weather extremes, such as wind or cold.
- Subjects who consume excessive amounts of alcohol or use drugs of abuse.
- Subjects who have participated in an investigational drug study within 30 days prior
to baseline.
- Subjects who have been previously enrolled in this study.
- Subjects who have had laser therapy, electrodesiccation and phototherapy to the
facial area within 180 days prior to study entry.
- Subjects who have had cosmetic procedures which may affect the efficacy and safety
profile of the investigational product within 14 days prior to study entry. Cosmetic
procedures and facials are prohibited throughout the study.
- Subjects who currently have or have recently had bacterial folliculitis on the face.
