CTRI/2018/12/016605 [Registered on: 11/12/2018] Trial Registered Prospectively
Last Modified On:
29/07/2022
Post Graduate Thesis
No
Type of Trial
Interventional
Type of Study
Drug
Study Design
Randomized, Parallel Group Trial
Public Title of Study
Compare the Efficacy and Safety of Adapalene and Benzoyl Peroxide Gel, 0.3%/2.5% Gel in patients with Acne Vulgaris.
Scientific Title of Study
A Randomized, Double-Blind, Multicenter, Three arm, Active and Placebo Controlled, Parallel Study to Evaluate the Bioequivalence (with clinical endpoint) of Adapalene and Benzoyl Peroxide Gel, 0.3%/2.5% (Cadila Healthcare Ltd, India) to EPIDUO® FORTE (Adapalene and Benzoyl Peroxide) Gel, 0.3%/2.5% (Galderma Laboratories, L.P., USA) in Subjects with Acne Vulgaris.
Sarkhej Road, Ahmedabad-380055, Gujarat, India. Ahmadabad GUJARAT
9904704445
nipp257@yahoo.in
Drkalpesh Shah
DHL Research centre, Thakershy Charitable Trust Hospital
1st floor,DHL research Centre
Thakershy Charitable trust Hospital,
Near Shivranjani Cross Road,Satellite,
Ahmedabad-380015,Gujarat,India Ahmadabad GUJARAT
9825322767
drkalpeshshahskin@gmail.com
Dr Panna Shah
Dr. Jivraj Mehta Smarak Health Foundation
Basement Research Department , Dr. Jivraj Mehta
Smarak Health Foundation , Bakeri Medical research Centre , Ratubhai Adani Arogyadham , Dr. Jivraj Mehta Marg, Paldi Ahmadabad, Gujarat, 380007, India.
Ahmadabad GUJARAT
9428608796
drshahpanna@gmail.com
Dr Jayesh Mukhi
Government Medical College and Hospital
Dept. of Skin , VD and
Leprology , 1st Floor Clinical research department, Government Medical College and Hospital, Medical Square Road,440003, Maharashtra
Nagpur MAHARASHTRA
9822467967
jayesh.mukhi@rediffmail.com
Dr Nipul Vara
Government Medical College and SSG Hospital
Ground Floor, Department Of Dermatology, Government Medical College and SSG Hospital Jail Road ,Indira Avenue, Sayaji ganj , Vadodara-390001,Gujarat Vadodara GUJARAT
9426074084
nipulvara@yahoo.co.in
Dr Kranti Chandan Jaykar
Indira Gandhi Institute Of Medical Sciences
2nd floor, OPD Building, Indira Gandhi Institute Of Medical Sciences , Sheikhpura , Patna , Bihar-800014, India Patna BIHAR
896995314
drkcjaykar@yahoo.co.in
Dr Tulika Rai
Institute Of medical Sciences, Banaras Hindu University
2nd floor, Department of Dermatology & Venereology Institute Of medical Sciences , Banaras Hindu University, Vranasi ,Uttar Pradesh , India-221005 Varanasi UTTAR PRADESH
9161023651
raitulika@gmail.com
Dr Vaidya Pradyumna Prakash
Jehangir Clinical Development Centre Pvt. Ltd
Jehangir Hospital Premises, 32 Sassoon Road, Pune-411001, Maharashtra, India Pune MAHARASHTRA
9822400964
drpvaidya@gmail.com
Dr Pramod Kumar
Kasturba Medical College Hospital
Attavar, Mangaluru-575001, Karnataka, India Udupi KARNATAKA
08242445858
pkderm@hotmail.com
Dr Adarsh Gowda
Kempegowda Institute Of Medical Sciences Hospital
Department of Dermatology, B–block, OPD Building, Room No-10,Ground Floor, Kempegowda Institute Of Medical Sciences Hospital K.R.Road ,V.V.Puram , Bangalore 560004 Bangalore KARNATAKA
9686100333
adarshgowda@hotmail.com
Dr Gummadi Purnima
New Govt. General Hospital (Associate By Siddhartha Medical College)
Ring Road, Gunadala, Vijayawada-520008, Andhra Pradesh, India Krishna ANDHRA PRADESH
9866163279 8662450391 gummadipurnima@gmail.com
Dr Dipak Patel
Nirmal Hospital
5th Floor Cinical Research Room, Nirmal Hospital Pvt. Ltd .,Ring Road, Surat-395002,Gujarat Surat GUJARAT
9374711540
dipakpatel@gamil.com
Dr Manjunath Shenoy
Omega Hospital (P) LTD
Omega Hospital, Mahaveer circle,Kankandy, Mangalore-575002, Karnataka, India Dakshina Kannada KARNATAKA
3rd floor Clinical trial
Department , Sujata Birla Hospital &Medical Research Center, Opposite to Bytco college, Nashik Pune Highway , Nashik Road ,Nashik ,Maharashtra-422101
Nashik MAHARASHTRA
9373901829
suneel.vartak@gmail.com
Dr Som Lakhani
Sumandeep Vidyapeeth and Dhiraj general hospital
Room No-5B, Ground floor Clinical trial Department, Sumandeep Vidyapeeth
and Dhiraj general
hospital , At & Po- Piparia , Waghodia , Dist-
Vadodar a-391760,Gujarat
Vadodara GUJARAT
Yash Society’s Sujata Birla Hopsital Ethics Committee
Approved
Regulatory Clearance Status from DCGI
Status
Approved/Obtained
Health Condition / Problems Studied
Health Type
Condition
Patients
(1) ICD-10 Condition: L700||Acne vulgaris,
Intervention / Comparator Agent
Type
Name
Details
Intervention
Adapalene and Benzoyl Peroxide Gel, 0.3%/2.5%
Subject have to apply a thin film of gel over entire area of affected skin of face, using fingertips once daily in the evening for 84 consecutive days.
Comparator Agent
EPIDUO® FORTE (Adapalene and Benzoyl Peroxide) Gel, 0.3%/2.5%
Subject have to apply a thin film of gel over entire area of affected skin of face, using fingertips once daily, in the evening for 84 consecutive days.
Inclusion Criteria
Age From
12.00 Year(s)
Age To
40.00 Year(s)
Gender
Both
Details
1. Healthy male or non-pregnant female aged ≥ 12 and ≤ 40 years with a clinical diagnosis of Acne vulgaris with facial involvement.
2. On the face, ≥ 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).
3. Investigator’s Global Assessment (IGA) of acne severity grade 2, 3 OR 4 (refer the table below)
Score Description
0 Clear skin with no inflammatory or noninflammatory lesions
1 Almost clear; rare non-inflammatory lesions with no more than one small inflammatory lesion
2 Mild severity; greater than Grade 1;Some non-inflammatory lesions with no more than a few inflammatory lesions (papules/ pustules only, no nodular lesions)
3 Moderate Severity; greater than Grade 2; up to many noninflammatory lesions and may have some inflammatory lesions, but no more than one small nodular lesion
4 Severe; greater than Grade 3; up to many noninflammatory lesions and may have some inflammatory lesions, but no more than a few nodular lesions
4. Willing to refrain from use of all other topical acne medications or antibiotics during the 12 weeks treatment period.
5. Male subjects and female of childbearing potential, willing to use an acceptable form of birth control including abstinence, from study start to 7 days after the last application of study medication.
6. Have used the same brand of make-up for a minimum period of 2 weeks prior to randomization, for subjects who use make-up, and agree to not change make-up brands or types during the study.
7. Willing to provide written informed consent or assent (as applicable).
ExclusionCriteria
Details
1. Females who are breast feeding, pregnant or planning to become pregnant.
2. 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, acneform eruptions caused by medications, steroid acne, steroid folliculitis, or bacterial folliculitis).
3. Subjects who have acne conglobata, acne fulminans and secondary acne (e.g.: chloracne and drug induced acne).
4. Excessive facial hair (e.g. beards, sideburns, moustaches, etc.), tattoos that would interfere with diagnosis or assessment of acne vulgaris. Well-trimmed moustaches are allowed. Subjects who have performed wax epilation of the face within 14 days prior to baseline.
5. History of hypersensitivity or allergy to adapalene, retinoids and/or any of the study medication ingredients.
6. Subjects who have a severe or intense irritation on the Face.
7. Use within 6 months prior to baseline (Randomization) or during the study of oral retinoids (e.g. Accutane®) or therapeutic vitamin A supplements of greater than 10,000 units/day (multivitamins are allowed).
8. Use for less than 3 months prior to baseline (Randomization) of estrogens or oral contraceptives; use of such therapy is allowed, if it will remain constant throughout the study.
9. Use on the face within 1 month prior to baseline (Randomization) or during the study of: 1) cryodestruction or chemodestruction, 2) dermabrasion, 3) photodynamic therapy, 4) acne surgery, 5) intralesional steroids, or 6) x-ray therapy or 7) chemical or laser peel.
10. Use within 1 month prior to baseline (Randomization) of: 1) androgen receptor blockers for acne (such as spironolactone or flutamide), 2) systemic steroids (including intranasal and inhaled corticosteroids), 3) systemic antibiotics, 4) systemic treatment for acne vulgaris (other than oral retinoids, which require a 6-month washout), or 5) systemic anti-inflammatory agents.
11. Use within 2 weeks prior to baseline or during the study of 1) topical steroids, 2) topical retinoids, 3) topical acne treatments including over-the-counter preparations, 4) topical anti-inflammatory agents, or 5) topical antibiotics.
12. Use of astringents and toners for less than 2 weeks prior to the start of the study.
13. Use of abradants, facials, peels containing glycolic or other acids, masks; washes or soaps containing benzoyl peroxide, salicylic acid, or sulfacetamide sodium; non-mild facial cleansers; moisturizers that contained retinol, salicylic acid or α- or β-hydroxy acids within the previous 2 weeks
14. Concomitant use/planned to use of mega-doses of certain vitamins (such as vitamin D [>2000 IU/day], vitamin B6 [> 2 mg/day] and vitamin B12 [> 1 mg/day]), haloperidol, halogens such as iodide and bromide, lithium, hydantoin and phenobarbital.
15. Anti-pruritic, including antihistamines, within 24 hours of baseline visits
16. Use of tanning booths or tanning lamps within 1 week prior to baseline and an unwillingness to refrain from use during the study.
17. A significant medical history of or are currently immunocompromised or receiving immunomodulators/biologics since last 3 months.
18. Have any systemic or dermatologic disease that may affect the evaluation of study results.
19. Subjects with clinically significant unstable medical disorders, life-threatening disease, or current malignancies.
20. Subjects who engage in activities that involve excessive or prolonged exposure to sunlight or weather extremes, such as wind or cold.
21. Subjects who are institutionalized.
22. Current drug abuse (including, but not limited to, cannabinoids and cocaine) or alcohol abuse (greater than two drinks per day).
23. Subjects with any local tolerability assessment score 3 (severe, marked/intense).
24. Lived in the same household as currently enrolled subjects.
25. Subjects who have been treated with an investigational drug or investigational device within a period of 30 days prior to study enrollment.
26. Subjects who have been previously enrolled in the study.
27. Clinically significant abnormal findings or condition (other than acne vulgaris), which might, in the opinion of the Investigator, interfere with study evaluations or pose a risk to subject safety during the study.
Method of Generating Random Sequence
Computer generated randomization
Method of Concealment
Not Applicable
Blinding/Masking
Participant and Investigator Blinded
Primary Outcome
Outcome
TimePoints
Mean percent change from baseline to week 12 (Day 84) in the inflammatory (papules and pustules) and non-inflammatory (open and closed comedones) lesion counts.
Week 12 (Day 84)
Secondary Outcome
Outcome
TimePoints
Proportion of subjects with a clinical response of “Success†at week 12.
Note: Success will be defined as an IGA score that is at least 2 grades less than the baseline assessment. Failure will be defined as an IGA score that is the same, higher or one grade lower than the baseline assessment.
Individual Participant Data (IPD) Sharing Statement
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Brief Summary
This is a Randomized, Double-Blind, Multicenter, Three arm, Active and Placebo Controlled, Parallel Study in the ratio of 2:2:1 of Test product, Reference product and Placebo. Study objective is 1) To evaluate bioequivalence (with clinical endpoint) of Test formulation (Adapalene and Benzoyl Peroxide Gel, 0.3%/2.5%) of Cadila Healthcare with Reference formulation (EPIDUO® FORTE Gel of Galderma Laboratories, L.P., USA). 2) To evaluate superiority of test and reference formulation to placebo. 3) To assess safety and tolerability of study treatments.
Patients of male and female patients between age of 12 to 40 (both inclusive) will be considered for the study. Patient to apply IP once daily over the face at night for 84 days.