A clinical trial to study the effect of three drugs Adapalene Gel USP, 0.1 %, Differin® (Adapalene) Gel, 0.1% and Placebo topical gel in healthy males and nonpregnant female subjects with acne vulgaris
- Conditions
- Acne vulgaris,
- Registration Number
- CTRI/2020/02/023490
- Lead Sponsor
- Aurobindo Pharma
- Brief Summary
This is a randomized, double blind, placebo-controlled,three-arm, parallel group, multi-centric study to evaluate the efficacy and safety of Adapalene Gel USP, 0.1 % in subjects with acne vu-lgaris [GroupI (Test): Adapalene Gel USP, 0.1 %;Group II (Reference): Differin® (Adapalene) Gel, 0.1%; and GroupIII: Placebo].
A total offive visits will be scheduled to the investigator site [i.e., Screening/Randomization Visit-1 (Day 0), On-treatment visits (Visit -2-Day 14, Visit-3-Day 28 and Visit 4- Day 56) and the End of Study (EOS) Visit-5 (Day 85)]. Therewill be window period of ± 4 days for each visit. Two subjects from same household will not be enrolled inthe study.
Allsubjects will be reported to the study site for screening. After completion ofthe required screening tests and procedures, subjects meeting all the inclusioncriteria and none of the exclusion criteria will be randomized and the day willbe considered as Day 0. Subjects will be provided with study medication (eitherTest or Reference or Placebo in 2:2:1 ratio as per the randomization schedule).He/ she needs to applya thin film of either Test or Reference or Placebo gel once daily to the entireface once daily in evening for 12 weeks after cleaning the face with amild or soapless, non-medicated cleanser, pat dry.
Subjects need to report to the Investigator site on day 14, day 28and day 56 with windowperiod of ± 4 days for each visit. At these visits,efficacy and safety evaluation will be done. Subjects will go through all theend of study evaluation procedures on end of study visit (Day 85).
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Not Yet Recruiting
- Sex
- All
- Target Recruitment
- 980
Healthy male or non-pregnant female aged between ≥ 12 and ≤ 40 years with a clinical diagnosis of acne vulgaris Subject having ≥ 25 non-inflammatory lesions (i.e., open and closed comedones) and ≥ 20 inflammatory lesions (i.e., papules and pustules) and ≤ 2 nodulocystic lesions (i.e., nodules and cysts) on the face Subject having clinical diagnosis of acne vulgaris severity grade 2, 3, or 4 as per IGA scale in Appendix-3 Subject willing to refrain from use of all other topical acne medications or antibiotics during the 12 week treatment period Subject/ LAR willing to give their written informed consent (incase of subject with age ≥ 18 years) and written informed assent (incase of subject < 18 years) to participate in the study Female of childbearing potential, willing to use an acceptable form of birth control during the study.
Subject having presence of any 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, acne form eruptions caused by medications, steroid acne, steroid folliculitis or bacterial folliculitis) Subject having excessive facial hair (e.g. beards, sideburns, moustaches etc.) that would interfere with diagnosis or assessment of acne vulgaris Subject with history of hypersensitivity or allergy to Adapalene, retinoids and/or any of study medication ingredients or anaphylactoid/anaphylactic reactions (e.g., skin rash, pruritus, hives, chest pain, edema, and shortness of breath) Subject used oral retinoids (e.g. Accutane®) or therapeutic vitamin A supplements of greater than 10,000 units/day (multivitamins are allowed) within 6 months prior to baseline Subject used estrogens or oral contraceptives for less than 3 months prior to baseline; use of such therapy must remain constant throughout the study Subject used cryodestruction or chemodestruction, dermabrasion, photodynamic therapy, acne surgery, intralesional steroids, or x-ray therapy on face within 1 month prior to baseline or planning to use during the study Subject used systemic steroids, systemic antibiotics, systemic treatment for acne vulgaris (other than oral retinoids, which require a 6 month washout), or systemic anti-inflammatory agents within 1 month prior to baseline or planning to use during the study Subject used topical steroids, topical retinoids, topical acne treatments including over-the-counter preparations, topical anti-inflammatory agents, or topical antibiotics within 2 weeks prior to baseline or planning to use during the study Subject who is planning to use spironolactone during the study Subject who had participated in another investigational drug or device research study within 30 days of enrolment Subject who used any medication or has any disease which in the judgment of the Investigator will interfere with the conduct or interpretation of the study Female subject who is pregnant, nursing or planning a pregnancy during the study Subject who is using preparations containing sulfur, resorcinol, or salicylic acid Subject with known history of HIV, HBsAg and HCV.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method •Mean percent change from baseline to week 12 in the non-inflammatory (open and closed comedones) lesion count. Visit 2, 3, 4 and 5 Mean percent change from baseline to week 12 in the inflammatory (papules and pustules) lesion count. Visit 2, 3, 4 and 5
- Secondary Outcome Measures
Name Time Method Proportion of subjects with a clinical response of success at week 12. Percentage of subjects who achieved at least 50 % reduction in lesion counts (inflammatory, non-inflammatory and total lesion count) at week 12.
Trial Locations
- Locations (24)
Amena Khatun General Hospital
🇮🇳Ahmadabad, GUJARAT, India
Apollo Hospital,
🇮🇳Hyderabad, TELANGANA, India
College of Medicine & Sagore Dutta Hospital
🇮🇳Kolkata, WEST BENGAL, India
Cresent Hospital and Heart Center
🇮🇳Nagpur, MAHARASHTRA, India
Department of Skin & VD Institute of Medical Sciences
🇮🇳Khordha, ORISSA, India
DR. D.Y Patil Hospital
🇮🇳Mumbai, MAHARASHTRA, India
Gadag institute of medical Sciences
🇮🇳Gadag, KARNATAKA, India
Gokuldas Tejpal Hospital, Grant Govt Medical College and JJ Group Hospital
🇮🇳Mumbai, MAHARASHTRA, India
Govt of medical college & hospital
🇮🇳Nagpur, MAHARASHTRA, India
Gurushree Hi-Tech Multi-Specialty Hospital
🇮🇳Bangalore, KARNATAKA, India
Scroll for more (14 remaining)Amena Khatun General Hospital🇮🇳Ahmadabad, GUJARAT, IndiaDr Ipsa PandyaPrincipal investigator9904704445niip257@yahoo.in