A clinical trial to study the effects of two drugs Adapalene and Benzyl peroxide topical gen in patients with mild to moderate with facial acne vulgaris.
- Conditions
- Other disorders of skin and subcutaneous tissue in diseases classified elsewhere,
- Registration Number
- CTRI/2019/12/022244
- Lead Sponsor
- BELUPO Pharmaceuticals and Cosmetics Incorporated
- Brief Summary
Subjects who were given the consent to participate in the study and qualified in inclusion exclusion criteria as per requirement of the protocol are included in the study. Subjects will be randomized according to the randomization scheme (either Test or Reference or Placebo in 2:2:1 ratio as per the randomization schedule) of this study. Subjects will be required to come to site for 5 visits. Visit 01 is Day 0 (Screening and randomization), visit 2 (Day 14), visit 3 (Day 28), Visit 4 (Day 56), Visit 5 (Day 84- End of study) each visit have a window period of ± 4 days in each visit subject will undergo Efficacy evaluation by assessing lesion count and severity by using the IGA for acne vulgaris and facial photography also taken.
During visit 1 and visit 3 Investigational products will be provided to the subject by unblinded site personal as per randomization scheme along with IP subjects are provided with instructions regarding application and subject diary to document daily application.
Subjects will be advised to apply thin film of Adapalene 0.1% and Benzoyl Peroxide 2.5% Topical Gel once daily at evening over the acne affected area for 84 days, after completing 84 the day treatment subjects will be visiting the site (Visit 5) for end of study procedure.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- All
- Target Recruitment
- 650
- 1.Healthy male or non-pregnant female aged between ≥ 12 and ≤ 40 years with a clinical diagnosis of facial acne vulgaris 2.Subject having ≥ 30 to ≤ 100 non-inflammatory lesions (i.e., open and closed comedones) and ≥ 20 to ≤ 50 inflammatory lesions (i.e. papules and pustules) and or ≤ 1 nodulocystic lesions (i.e., nodules and cysts) on the face which will be evaluated as per the Format of Appendix 4 by Principal investigator/Co-Investigator 3.Subject having clinical diagnosis of facial acne vulgaris severity grade 2 or 3 as per IGA(Appendix7) 4.Subject willing to refrain from use of all other topical acne medications or antibiotics during the 84 days treatment period 5.Subject/ LAR/ parent/ guardian/ Impartial Witness willing to give their written informed consent and written informed assent (in case of subject < 18 years) to participate in the study 6.Subject used the same brand of make-up for a minimum period of 2 weeks prior to randomization and willing to agree to not change the make-up brands or types during the study 7.Females must use acceptable and effective methods of contraception such as the following: A)Sexual abstinence B)Double barrier method C)Intrauterine Device (IUD) D)Progestin Implant (i.e. Implanon or its equivalent) E)Oral contraceptives 8.Medical history and physical examination without clinically relevant abnormalities 9.All vital signs (i.e. blood pressure, body temperature, heart and respiration rate) within the normal range: systolic blood pressure: 100.
- 140 mmHg diastolic blood pressure: 60.
- 90 mmHg body temperature: for axillary readings [97°F (36.1°C).
- 99°F (37.2°C)], or for oral readings [98°F (36.7°C).
- 100°F (37.8°C)] heart rate (pulse): 60.
- 100 bpm respiration rate: 12.
- 20 breaths/min Blood pressure will be measured after the subject has rested for at least 5 minutes in supine position.
- 1.Subject having presence of any skin condition that would interfere with the diagnosis or assessment of facial 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) 2.
- Subject having excessive facial hair (e.g. beards, sideburns, moustaches etc.) that would interfere with diagnosis or assessment of acne vulgaris as per the discretion of Principal investigator (PI) 3.
- Subject with history of hypersensitivity or allergy to any medication (regardless the method of administration) and/or cosmetic product.
- Subject used oral retinoids (e.g. Isotretinoin) or therapeutic vitamin A supplements of greater than 10,000 units/day (multivitamins are allowed) within 6 months prior to baseline 5.
- Subject used estrogens or oral contraceptives for less than 3 months prior to baseline; use of such therapy must remain constant throughout the study 6.
- 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 7.
- Subject used systemic steroids, systemic antibiotics, systemic treatment for acne vulgaris (other than oral retinoids, which require a 6 month washout), systemic anti-inflammatory agents or immunosuppressive drugs within 1 month prior to baseline or planning to use during the study 8.
- Subject used topical steroids, topical retinoids, topical acne treatments including over-the-counter preparations, topical anti-inflammatory agents, or topical antibiotics on the face within 2 weeks prior to baseline or planning to use during the study 9.
- Subject used tanning booths, sunbathing or excessive exposure to the sun or planning to use during the study 10.
- Subject with damaged skin on his/her face, either broken (cuts or abrasions), eczematous or sunburned.
- Subject who is planning to use spironolactone during the study 12.
- Subject who had participated in another investigational drug or device research study within 30 days of enrolment 13.
- 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 14.
- Female subject who is pregnant, nursing or planning a pregnancy during the study 15.
- Any reason for which, in the opinion of the Investigator, the subject should not participate in the study.
Study & Design
- Study Type
- BA/BE
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Mean percent change from baseline to week 12 (day 84) in the inflammatory (papules and pustules) lesion count. Visit 1,2,3,4&5 Mean percent change from baseline to week 12 (day 84) in the non-inflammatory (open and closed comedones) lesion count. Visit 1,2,3,4&5
- Secondary Outcome Measures
Name Time Method Proportion of subjects with a clinical response of success at week 12 (day 84). Percentage of subjects who achieved at least 50 % reduction in lesion counts (inflammatory, non-inflammatory and total lesion count) at week 12 (day 84).
Trial Locations
- Locations (19)
Amena Khatun General Hospital
🇮🇳Ahmadabad, GUJARAT, India
Calcutta National Medical College
🇮🇳Kolkata, WEST BENGAL, India
Chopda Medicare &Research Center
🇮🇳Nashik, MAHARASHTRA, India
College of Medicine & Sagore Dutta Hospital
🇮🇳Kolkata, WEST BENGAL, India
Deoyani Multi-Specialty Hospital
🇮🇳Pune, MAHARASHTRA, India
Gurushree Hi-Tech Multi-Specialty Hospital
🇮🇳Bangalore, KARNATAKA, India
Ishwar Institute of Health Care
🇮🇳Aurangabad, MAHARASHTRA, India
Kanoria Hospital and Research centre
🇮🇳Gandhinagar, GUJARAT, India
Lotus multi speciality hospital
🇮🇳Ahmadabad, GUJARAT, India
MTES’s Sanjeevan Hospital
🇮🇳Pune, MAHARASHTRA, India
Scroll for more (9 remaining)Amena Khatun General Hospital🇮🇳Ahmadabad, GUJARAT, IndiaDr Ipsa PandyaPrincipal investigator9904704445niip257@yahoo.in