A study to check effectiveness of Adapalene and Benzoyl peroxide Gel in patients with Acne Vulgaris
Scientific Title of Study
A Randomized, Double-blind, Multicentric, Parallel-group, Active and Placebo Controlled, Three Arm Clinical Study to Compare the Efficacy and Safety of Adapalene 0.1% and Benzoyl peroxide 2.5% Gel (Morningside Healthcare Ltd, UK) versus EPIDUO 0.1%/2.5% Gel (Galderma U.K Ltd) in Subjects with Acne Vulgaris.
Trial Acronym
Secondary IDs if Any
Secondary ID
Identifier
CRL061826 Version 2.0 Date 11 Sep 2018
Protocol Number
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
Name
Dr Dharmesh Domadia
Designation
Associate Vice President - Global Clinical Operations
Affiliation
Cliantha Research Limited
Address
Cliantha Research Limited,
Opp. Pushpraj Towers, Near Judges Bungalows, Bodakdev, Ahmedabad-380054, Gujarat, India
Ahmadabad GUJARAT 380054 India
Phone
09879590828
Fax
07966219549
Email
ddomadia@cliantha.in
Details of Contact Person Scientific Query
Name
Dr Praveen Chowdhary
Designation
Assistant Manager Medical Services
Affiliation
Cliantha Research Limited
Address
Cliantha Research Limited,
Opp. Pushpraj owers, Near Judges Bungalows, Bodakdev, Ahmedabad-380 054, Gujarat, India
Ahmadabad GUJARAT 380054 India
Phone
09879363847
Fax
07966219549
Email
pchowdhary@cliantha.in
Details of Contact Person Public Query
Name
Mr Devesh Verma
Designation
Project Manager – Clinical Trials
Affiliation
Cliantha Research limited
Address
Cliantha Research Limited,
Opp. Pushpraj Towers, Near Judges Bungalows, Bodakdev, Ahmedabad-380054, Gujarat, India
Ahmadabad GUJARAT 380054 India
Phone
09712908404
Fax
07966219549
Email
dverma@cliantha.in
Source of Monetary or Material Support
Morningside Healthcare Ltd, UK
Primary Sponsor
Name
Morningside Healthcare Ltd
Address
Morningside Healthcare Ltd., Morningside House, Unit C, Harcourt Way, Meridian Business Park, Leicester, LE19 1WP, UK
Sarkhej Road, Ahmedabad-380055 Gujarat, India Ahmadabad GUJARAT
9904704445
niip257@yahoo.in
Dr Anil Gosavi
B.J. Government Medical College & Sassoon Gen Hospital
Dep. Of Skin & V.D. B.J. Government Medical College & Sassoon Gen Hospital, Pune -411001 Maharashtra, India Pune MAHARASHTRA
09823618161
dranilgosavi@hotmail.com
Dr Som Lakhani
Dhiraj General Hospital
Dept. of Skin & VD, Ground floor Clinical trial Department, Sumandeep Vidyapeeth, At & Po Piparia, Ta Waghodia, Dist. Vadodara 391760, Gujarat, India
Vadodara GUJARAT
09825350198
somlakhani24@gmail.com
Dr Kalpesh Shah
DHL Research Centre
2nd Floor, DHL Research Centre, Thakershy Charitable Trust Hospital, Near Shivranjani Cross Road, Satellite, Ahrnedabad-380015, Gujarat, India. Ahmadabad GUJARAT
09825322767
DRKALPESHSHAHSKIN@GMAIL.COM
Dr G Narsimha Rao Netha
Gandhi Hospital
5Th Floor, Gandhi Hospital, Musheerabad, Secunderabad, Telangana-500003 India Hyderabad TELANGANA
Ground Floor, Dept. of Dermatilogy, Jail Road, Indira Avenue, Sayajiganj, Vadodara - 390001 Gujarat, India. Vadodara GUJARAT
09426074084
nipulvara@yahoo.co.in
Dr Kranti Chandan
Indira Gandhi Institute of Medical Sciences
Department of Skin and VD, Clinical Trial Room, Room no. 229, Second Floor , Sheikhpura, Patna, Bihar-800014, India Patna BIHAR
08969953194
drkcjaykar@yahoo.co.in
Dr Tulika Rai
Institute of medical Sciences
Clinical research Room no. 1 and 2, 1st Floor, dermatology department, Banaras Hindu University Varanasi-221005 Uttar Pradesh India Varanasi UTTAR PRADESH
09161023651
raitulika@gmail.com
Dr Panna Shah
Jivraj Mehta Hospital
Basement, Clinical Research department, Dr. Jivraj Mehta Smarak Health Foundation , Bakeri Medical Research centre, " Rutubhai adani arogya dham " , Dr. Jivraj Mehta Marg Ahmedabad,
Gujarat-380007
Ahmadabad GUJARAT
09428608796
drshahpanna@gmail.com
Dr Adarsh Gowda
KIMS Hospital
Dept. of Dermatology, B Block, OPD Building, Ground Floor, KR Road, VV Puram, Bangalore - 560004, Karnataka Bangalore KARNATAKA
09686100333
adarshgowda@hotmail.com
Dr Keyur Shah
Medilink Hospital Research Centre
Basement Medilink Hospital, Nr. Shyamal Cross Road, 132 ft. Ring Road, Satelite, Ahmedabad-380015, Gujarat, India Ahmadabad GUJARAT
09879004822
drkeyurshah@yahoo.com
Dr BLN Swamy
MMC & RI, K.R. Hospital
Dept. of Skin & S.T.D., Clinical trial Room next
to PWD office , Irwin Road, Mysore, Karnataka - 570001
Mysore KARNATAKA
Dr. Jivraj Mehta Smarak Health Foundation , Bakeri Medical Research centre,
Approved
Insititutional Ethics Committee, Dept. of Pharmacology, Govt. Medical College, Nagpur. Maharashtra - 440003
Approved
Insititutional Ethics Committee,B.J. Government Medical College & Sassoon Gen Hospital, Pune -411001 Maharashtra, India
Approved
Institutional Ethics Committee for Human Research, Pharmacology Dept. Medical College & SSG Hospital, Jail Road, Indira Avenue, Vadodara - 390001, Gujarat, India.
Approved
Institutional Ethics committee Institute of medical Sciences Banaras hindu University Varanasi-221005 Uttar Pradesh India
Approved
Institutional Ethics Committee, Gandhi Medical College, Secunderabad
Approved
Institutional Ethics Committee, Indira Gandhi Institute of Medical Sciences, Sheikhpura, Patna, Bihar-800014, India
Approved
Institutional Ethics Committee, Mysore Medical College and Research institute and Associated Hospitals, Dept. of Pathology, K.R. Hospital, Irwin Road, Mysore Karnataka - 570001
Approved
Institutional Ethics Committee, Nirmal Hospital Pvt Ltd Ring Road Surat -395002 Gujarat India
Approved
Institutional Ethics Committee, office of Principal Academic Building, Nil Ratan Sircar Medical College and Hospital, 138, A.J.C Bose Road, Kolkata-700014
Submittted/Under Review
Institutional Ethics Committee, Post Graduate Institute of Medical Education & Research, Sector 12, Chandigarh - 160012
Orange City Hospital Institutional Ethics Committee
Approved
Shree Hospital Ethics Committee, Shree Hospital Unit, Plot No. 786, 3rd floor, Behind Shree Hospital & Critical Care Center, Mirchi Bazar, Umrer Road, Sakkardara Square, Nagpur, Maharsshtra - 440009
Approved
Sudbhawana Hospital Ethics Committee
Approved
Sumandeep Vidyapeeth lnstitutional Ethics Committee. Research Cell, 2nd Floor, Department of Pharmacy, Sumandeep Vidyapeeth. At & Po. Piparia, fa Waghodia, Dist Vadodara 391760, Gujarat, India
Approved
Thakershy Charitable Trust Ethics Committee
Approved
Yash Society’s Sujata Birla Hospital Ethics Committee, Opposite to Bytco College, Nashik Pune Highway, Nashik Road, Nashik, Maharashtra, 422101
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 0.1% and Benzoyl
peroxide 2.5% Gel of Morningside
Healthcare Ltd, UK
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 Gel of Galderma (U.K)
Ltd
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
9.00 Year(s)
Age To
40.00 Year(s)
Gender
Both
Details
1. Healthy male or non-pregnant female aged ≥ 09 and ≤ 40 years with a clinical diagnosis of Acne vulgaris with facial involvement.
2. A minimum of 20 but not more than 50 inflammatory lesions (papules and pustules) on the face and not more than two acne nodules.
3. A minimum of 30 but not more than 100 non-inflammatory lesions (open comedones and closed comedones) on the face.
4 Investigator’s Global Assessment (IGA) of acne severity grade 3 OR 4 (refer
Table 5)
5. Willing to refrain from use of all other topical acne medications or antibiotics during the 12 weeks treatment period.
6. Male subjects and female of childbearing potential, willing to use an acceptable form of birth control including abstinence, from study start to 30 days after the last application of study medication.
7. 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.
8. Willingness and ability to comply with the protocol (for subjects under 18 years of age, the parent/LAR must also have been willing and able to comply with study requirements).
9. 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. Any acne cyst.
3. 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).
4. Subjects who have acne conglobata, acne fulminans, nodulocystic acne and secondary acne (e.g., chloracne and drug induced acne).
5. 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.
6. Subjects who have performed wax epilation of the face within 14 days prior to baseline.
7. History of hypersensitivity or allergy to adapalene, benzoyl peroxide, retinoids and/or any of the study medication ingredients
8. Subjects who have a severe or intense irritation on the Face.
9. 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).
10. 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.
11. 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.
12. 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.
13. Use within 2 weeks prior to baseline or during the study of 1) topical steroids, 2) topical retinoids, 3) topical acne treatments including over-thecounter preparations, 4) topical anti-inflammatory agents, or 5) topical antibiotics.
14. Use of astringents and toners for less than 2 weeks prior to the start of the
study.
15. 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.
16. 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.
17. Anti-pruritic, including antihistamines, within 24 hour of baseline visits
18. Use of tanning booths or tanning lamps within 1 week prior to baseline and an unwillingness to refrain from use during the study.
19. A significant medical history of or are currently immunocompromised or receiving immunomodulators/biologics since last 3 months.
20. Have any systemic or dermatologic disease that may affect the evaluation of
study results.
21. Subjects with clinically significant unstable medical disorders, life threatening
disease, or current malignancies..
22. Subjects who engage in activities that involve excessive or prolonged exposure to sunlight or weather extremes, such as wind or cold.
23. Subjects who are institutionalized.
24. Current drug abuse (including, but not limited to, cannabinoids and cocaine) or alcohol abuse (greater than two drinks per day).
25. Subjects with any local tolerability assessment score 3 (severe, marked/intense).
26. Lived in the same household as currently enrolled subjects.
27. Subjects who have been treated with an investigational drug or investigational device within a period of 30 days prior to study enrollment.
28. Subjects who have been previously enrolled in this study.
29. 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) for inflammatory
(papules and pustules) lesion count.
Mean percent change from baseline to week 12 (Day 84) in the noninflammatory
(open and closed comedones) lesion count.
At baseline, Week 4, Week 8 and week 12
Secondary Outcome
Outcome
TimePoints
Proportion of subjects with a clinical response of “success†at week 12.
12 week
Target Sample Size
Total Sample Size="550" Sample Size from India="550" Final Enrollment numbers achieved (Total)= "550" Final Enrollment numbers achieved (India)="550"
Individual Participant Data (IPD) Sharing Statement
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Brief Summary
A Randomized,
Double-blind, Multicentric, Parallel-group, Active and Placebo Controlled,
Three Arm Clinical Study to Compare the Efficacy and Safety of Adapalene 0.1%
and Benzoyl peroxide 2.5% Gel (Morningside Healthcare Ltd, UK) versus
EPIDUO 0.1%/2.5% Gel (Galderma U.K Ltd) in Subjects with Acne Vulgaris.
550 subjects
will be required to be enrolled (randomized) in the study for around 105 days
that includes screening periods of 14 days and treatment period of 12 weeks.
The end of the study will be the date of the last
study visit for the last subject in the study. The study will commence only
after the approval from the Local Regulatory Approval (DCGI).