A Bioequivalence Study With Clinical Endpoints Comparing Adapalene and Benzoyl Peroxide Topical Gel 0.1%/2.5% (Actavis Mid-Atlantic LLC) To Epiduo™ (Adapalene and Benzoyl Peroxide) Gel 0.1%/2.5% (Galderma Laboratories, L.P.) in the Treatment of Mild to Severe Acne Vulgaris
NCT ID: NCT01501799
Last Updated: 2011-12-29
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
NA
885 participants
INTERVENTIONAL
2011-07-31
2011-12-31
Brief Summary
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Detailed Description
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Conditions
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Keywords
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
TRIPLE
Study Groups
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Adapalene 0.1% and benzoyl peroxide 2.5% topical gel
adapalene 0.1% and benzoyl peroxide 2.5% topical gel
Dosage form: topical gel Dosage: A pea-sized amount was applied to each affected area of the face Frequency: once daily in the evening Duration: 12 weeks
EPIDUO™ (adapalene 0.1% and benzoyl peroxide 2.5%) Gel
EPIDUO
EPIDUO (adapalene 0.1% and benzoyl peroxide 2.5%) Gel
Vehicle Gel
Placebo (Vehicle Gel)
Vehicle Gel
Interventions
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adapalene 0.1% and benzoyl peroxide 2.5% topical gel
Dosage form: topical gel Dosage: A pea-sized amount was applied to each affected area of the face Frequency: once daily in the evening Duration: 12 weeks
EPIDUO
EPIDUO (adapalene 0.1% and benzoyl peroxide 2.5%) Gel
Placebo (Vehicle Gel)
Vehicle Gel
Eligibility Criteria
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Inclusion Criteria
2. Patients who are 18 years of age or older must have provided IEC/IRB approved written informed consent. Patients between the ages of 12 to 17 years of age must have provided IEC/IRB approved written assent; this written assent must be accompanied by an IEC/IRB approved written informed consent from the patient's legally acceptable representative (i.e., parent or guardian). In addition, all patients or their legally acceptable representatives (i.e., parent or guardian) must sign a HIPAA authorization, if applicable.
3. Patients must have a definite clinical diagnosis of mild to severe acne vulgaris (Grade 2, Grade 3 or Grade 4 on the IGE).
4. Patients must have a minimum of 20 inflammatory lesions and a maximum of 100 and a minimum of 25 and a maximum of 100 non-inflammatory lesions (i.e., open and closed comedones) and no more than 2 nodulocystic lesions (i.e., nodules and cysts) at baseline. For the purposes of study treatment and evaluation, these lesions should be limited to the facial treatment area. Lesions involving the eyes, angles of the nose (i.e., the lines around your nostrils and under the nostrils) and scalp should be excluded from the count. Patients may have acne lesions on other areas of the body (e.g., on the back).
5. Female patients of childbearing potential must have been using accepted methods of birth control or must agree to continue to practice abstinence, from 30 days prior to study entry to 30 days after the last administration of study drug. All female patients are considered to be of childbearing potential unless they have been surgically sterilized or have been postmenopausal for at least 1 year. Abstinence is an acceptable method of birth control. Any of the following methods of birth control are acceptable: oral contraceptives, contraceptive patches/implants (e.g., Norplant®) Depo-Provera®, double barrier methods (e.g., condom and spermicide) or IUD. Female patients must have a negative urine pregnancy test at baseline. A negative result of a pregnancy test having a minimum sensitivity of at least 50 mIU/ml for hCG should be obtained.
6. All male patients 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. Abstinence is an acceptable method of birth control. Any of the following methods of birth control are acceptable: oral contraceptives, contraceptive patches/implants (e.g., Norplant®), Depo-Provera®, double barrier methods (e.g., condom and spermicide) or IUD.
7. Patients must be willing and able to understand and comply with the requirements of the protocol, including attendance at the required study visits.
8. Patients must be willing to refrain from using any other treatments for acne vulgaris, including antibiotics, other than the investigational product, for acne present on the face. Patients may use other topical acne treatments that do not have significant or measurable systemic absorption for treatment of acne of the back, shoulders and chest (e.g., benzoyl peroxide, salicylic acid).
9. Patients must be in good health and free from any clinically significant disease.
10. Patients who use make-up must have used the same brands/types of make-up for a minimum period of 14 days prior to study entry and must agree to not change make-up brand/type or frequency of use throughout the study.
Exclusion Criteria
2. Patients who have a known hypersensitivity to benzoyl peroxide, adapalene, and other retinoids, or their excipients will be excluded from study participation.
3. Patients who have conditions that may interfere with the evaluation of acne vulgaris. Such conditions include, but are not limited to the following lesions on the face: rosacea; seborrheic dermatitis; perioral dermatitis; corticosteroid-induced acne or folliculitis; carcinoid syndrome; squamous cell carcinoma; mastocytosis; acneiform eruptions caused by make-up or medication; bacterial folliculitis; facial psoriasis; and facial eczema.
4. Patients who have acne congoblata, acne fulminans, and secondary acne (e.g., chloracne and drug induced acne) will be excluded from participation.
5. Patients who have been treated with systemic antibiotics or systemic anti-acne drugs or systemic anti-inflammatory drugs within 30 days prior to baseline will be excluded from study participation.
6. Patients who have been treated with prescription and/or over-the-counter topical medications for the treatment of acne vulgaris including antibiotics, topical corticosteroids, α-hydroxy/glycolic acid, benzoyl peroxide, or topical anti-inflammatory medications on the face within 14 days prior to baseline will be excluded from study participation.
7. Patients who are currently taking or have been treated with systemic corticosteroids (including intranasal and inhaled corticosteroids) within 30 days prior to baseline will be excluded from study participation.
8. Patients who have started hormonal therapy or changed the dosage of their hormonal therapy within 3 months prior to baseline will be excluded from study participation. The dosage and frequency of use of any hormonal therapy started greater than 3 months prior to baseline must remain unchanged throughout the study (Visit 1 through Visit 5). Hormonal treatments include, but are not limited to, estrogenic and progestational agents such as birth control pills.
9. Patients who use androgen receptor blockers (such as spironolactone or flutamide) will be excluded from study participation.
10. Patients who have received oral retinoids (e.g., isotretinoin) within 180 days prior to study entry,or have used therapeutic vitamin A supplements of greater than 10,000 units/day (multivitamins are allowed) within 180 days prior to study entry, or have applied topical retinoids (e.g., tretinoin, tazarotene, adapalene) to the face within the 2 weeks prior to baseline will be excluded from study participation.
11. Patients who have received radiation therapy and/or anti-neoplastic agents within 90 days prior to baseline will be excluded from study participation.
12. Patients who have unstable medical disorders that are clinically significant or life-threatening diseases will be excluded from study participation.
13. Patients who have on-going malignancies requiring systemic treatment will be excluded from study participation. In addition, patients who have any malignancy of the skin of the facial area will be excluded from study participation.
14. Patients who have facial hair will be excluded from study participation. Unacceptable facial hair includes, but is not limited to, beards, and long side-burns. A well-trimmed mustache is acceptable. Patients who have performed wax epilation of the face within 14 days prior to baseline will also be excluded from study participation.
15. Patients who engage in activities that involve excessive or prolonged exposure to sunlight or weather extremes, such as wind or cold, will be excluded from study participation.
16. Patients who consume excessive amounts of alcohol (greater than two drinks per day) or use drugs of abuse (including, but not limited to, cannabinoids and cocaine) as judged by history will be excluded from study participation.
17. Patients who have participated in an investigational drug study (i.e., patients have been treated with an investigational drug) within 30 days prior to baseline will be excluded from study participation. Patients who are participating in non-treatment studies such as observational studies or registry studies can be considered for inclusion.
18. Patients who have been previously enrolled in this study will be excluded from study participation.
19. Patients who have had within 30 days prior to baseline or during the study cryodestruction or chemodestruction, dermabrasion, photodynamic therapy, acne surgery, intralesional steroids, or x-ray therapy will be excluded from study participation.
20. Patients who have had laser therapy, and electrodessication to the facial area within 180 days prior to study entry will be excluded from participation.
21. Patients who have had cosmetic procedures (e.g., facials) which may affect the efficacy and safety profile of the investigational product within 14 days prior to study entry will be excluded from participation.
22. Patients who have had general anesthesia for any reason and patients who have received neuromuscular blocking agents within 14 days prior to study entry will be excluded from study participation.
23. Patients who have a baseline local irritation score of 3 (severe, marked/intense) as scored using the Application Site Reaction Scale (Section 5.2) will be excluded from participation.
12 Years
40 Years
ALL
No
Sponsors
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Actavis Mid-Atlantic LLC
INDUSTRY
Responsible Party
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Principal Investigators
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Nagashayana G., M.D.
Role: STUDY_DIRECTOR
Lotus Labs Pvt Ltd
Nermina Nakas, M.D., M.P.H.
Role: STUDY_DIRECTOR
Jubilant Clinsys, Inc
Locations
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Center for Dermatology Clinical Research Inc.
Fremont, California, United States
FXM Research Corp.
Miami, Florida, United States
FXM Research Miramar
Miramar, Florida, United States
The Indiana Clinical Trials Center
Plainfield, Indiana, United States
Adult & Pediatric Dermatology
Overland Park, Kansas, United States
Skin Search of Rochester Inc.
Rochester, New York, United States
Dermatology Consulting Services
High Point, North Carolina, United States
Haber Dermatology and Cosmetic Surgery Inc.
South Euclid, Ohio, United States
FXM Research International - Belize
Belize City, Belize District, Belize
Raga's Skin Care
Bangalore, Bangalore, India
MS Clinical Research Pvt. Ltd.
Bangalore, Bangalore, India
Chamarajpet Skin and Laser Centre
Chamarajpet, Bangalore, India
Rajbal Polyclinic & Research Center
Kalyan Nagar, Bangalore, India
Department of Skin & STD, Kempegowda Institute of Medical Sciences,
V.V. Puram, Bangalore, India
Bhagwan Mahaveer Jain Hospital
Vasanthnagar, Bangalore, India
Skin & Cosmetology Clinic
Banjara Hills, Hyderabad, India
Department of Dermatology, Durga Bai Deshmukh Hospital
Vidyānagar, Hyderabad, India
Bhatia Skin, Laser & Cosmetic Center
Anand Bazar, Indore, India
Swarnakar Super Specialty Centre
Anand Bazar, Indore, India
Skin Clinic
RNT Marg, Indore, India
Agrawal Skin & Laser Centre
Vijayanagar, Indore, India
Sri Gayathri Skin Care & Hair Transplant Centre
Dwarakanagar, Visakhapatnam, India
Dayal Clinic
Visakhapatnam, Visakhapatnam, India
B.V. Department of Dermatology King George Hospital
Visakhapatnam, Visakhapatnam, India
Skin & Cosmetology
Visakhapatnam, Visakhapatnam, India
Countries
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Other Identifiers
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ACTA/ADAP/BP/2010
Identifier Type: -
Identifier Source: org_study_id