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CTRI Number  CTRI/2019/12/022244 [Registered on: 03/12/2019] Trial Registered Prospectively
Last Modified On: 01/10/2020
Post Graduate Thesis  No 
Type of Trial  BA/BE 
Type of Study    
Study Design  Randomized, Parallel Group, Placebo Controlled Trial 
Public Title of Study   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.  
Scientific Title of Study   A multicentre, double-blind, randomized, single-period, placebo-controlled, parallel group study of Adapalene 0.1% and Benzoyl Peroxide 2.5% Topical Gel of BELUPO Inc., Croatia (Test) and Epiduo Gel (Adapalene 0.1% and Benzoyl Peroxide 2.5%) (Reference) of Galderma (EU) in subjects with mild to moderate facial acne vulgaris 
Trial Acronym   
Secondary IDs if Any  
Secondary ID  Identifier 
CR198-18  Protocol Number 
CR198-18 Version 1.0 Amendment-01 Dated 21.06.2019  Protocol Number 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Dr Subhra Lahiri 
Designation  Associate Vice President 
Affiliation  AXIS Clinicals Ltd  
Address  AXIS Clinicals Ltd 1 121 1 Miyapur Hyderabad 500049 Telangana INDIA

Hyderabad
TELANGANA
500049
India 
Phone  8886221089   
Fax  40408060  
Email  Subhra.L@axisclinicals.com  
 
Details of Contact Person
Scientific Query  
Name  Dr Subhra Lahiri 
Designation  Associate Vice President 
Affiliation  AXIS Clinicals Ltd  
Address  AXIS Clinicals Ltd 1 121 1 Miyapur Hyderabad 500049 Telangana INDIA

Hyderabad
TELANGANA
500049
India 
Phone  8886221089   
Fax  40408060  
Email  Subhra.L@axisclinicals.com  
 
Details of Contact Person
Public Query  
Name  Dr Subhra Lahiri 
Designation  Associate Vice President 
Affiliation  AXIS Clinicals Ltd  
Address  AXIS Clinicals Ltd 1 121 1 Miyapur Hyderabad 500049 Telangana INDIA

Hyderabad
TELANGANA
500049
India 
Phone  8886221089   
Fax  40408060  
Email  Subhra.L@axisclinicals.com  
 
Source of Monetary or Material Support  
BELUPO Pharmaceuticals and Cosmetics Incorporated Ulica Danica 5 48 000 Koprivnica Croatia Phone 385 1 2481 214 Fax 385 1 2481 290 
 
Primary Sponsor  
Name  BELUPO Pharmaceuticals and Cosmetics Incorporated 
Address  Ulica Danica 548 000 Koprivnica Croatia Phone: 385 1 2481 214 Fax: 385 1 2481 290  
Type of Sponsor  Pharmaceutical industry-Global 
 
Details of Secondary Sponsor  
Name  Address 
AXIS Clinicals Ltd   1-121/1 Miyapur Hyderabad-500049 Andhra Pradesh, INDIA P: 91 40 40408080 F: 91 40 40408060 www.Axisclinicals.com  
 
Countries of Recruitment     India  
Sites of Study  
No of Sites = 19  
Name of Principal Investigator  Name of Site  Site Address  Phone/Fax/Email 
Dr Ipsa Pandya  Amena Khatun General Hospital  Dermatology Dept Sarkhej Road Ahmadabad-380055 Gujarat India
Ahmadabad
GUJARAT 		 9904704445

niip257@yahoo.in 
Dr Abhishek DE  Calcutta National Medical College  Department of Dermatology 32 Gorachand Road Santoshpur, Kolkata-14, West Bengal-700075
Kolkata
WEST BENGAL 		 9903275551

abhishek_de@yahoo.co.in 
Dr Teja Hemant Kulkarni  Chopda Medicare &Research Center  Magnum Heart Institute 3/5, Patil Lane No.1 Laxmi Nagar, Near K.B.H. Vidyanagar Canada corner Nashik-422005, Maharashtra
Nashik
MAHARASHTRA 		 9422258282

tejakulkarni2000@yahoo.com 
Dr Indrashis Podder  College of Medicine & Sagore Dutta Hospital   College of medicinee and sagore datta hospital Dept of Dermatology BT Road Kamarhati Kolkata-700058
Kolkata
WEST BENGAL 		 9007977161

ipodder88@gmail.com 
Dr Sujit Shah  Deoyani Multi-Specialty Hospital  Plot No. 121, Lane Number 4 Dhanukar Colony, Kothrud Pune Maharashtra 411038
Pune
MAHARASHTRA 		 9970004295

drsujitshah@gmail.com 
Dr KC Nischal  Gurushree Hi-Tech Multi-Specialty Hospital  No.1558, Opp. Chandra lay out bus Stand Chandra lay out Vijaya Nagar Bengalore-560040
Bangalore
KARNATAKA 		 9825199585

drnischal@nirmalaskinclinic.com 
Dr Prashant Keshav Rao Palwade  Ishwar Institute of Health Care  1ST floor, Ishwar Heights Plot. No 7 Gut No. 6/1, beside Punjabi Bhavan Padegaon Aurangabad-Maharashtra – 431002
Aurangabad
MAHARASHTRA 		 9323707031

Prashantpalwade@gmail.com 
Dr Saurabh Dineshchandra Kapadia  Kanoria Hospital and Research centre  Kanoria Hospital and Research centre Airport Gandhi nagar highway Village Bhat Dist Gandhinagar Gujarat India 382428
Gandhinagar
GUJARAT 		 9824261031

drsaurabhkapadia@yahoo.com 
Dr Neha Sharma  Lotus multi speciality hospital  Lotus Multi Speciality Hospital, Block N, Krupa Residency, Motera Stadium Road, Motera-Sabarmati, Ahmedabad Gujarat 380005
Ahmadabad
GUJARAT 		 9766014730

ns140786@gmail.com 
Dr Pradeep Mahajan  MTES’s Sanjeevan Hospital  Plot no: 23, off Carve Road Kashibai Khilare Path Opposite Pune Central Pune Maharashtra 411004
Pune
MAHARASHTRA 		 8793226922

drmpradeep1@gmail.com 
Dr Dipak Patel  Nirmal hospital pvt ltd  Department of Dermatology,Nirmal hospital pvt ltd Ring road Surat 395002 Gujarat India
Surat
GUJARAT 		 9374711540

dr.dipak.patel@gmail.com 
Dr Sudhir Mamidwar  Orange City Hospital & Research Institute   Consultant Dermatologist, 19, Pandey Layout, Veer Sawarkar Square Nagpur-440015, Maharashtra
Nagpur
MAHARASHTRA 		 9881015523

drmamidwarsudhir@gmail.com 
Dr Jigar Parikh   Ratandeep Multi-Speciality Hospital  5th floor. Nakshatra complex, above HDFC bank, Maninagar cross road Maninagar Ahmadabad-380008 Gujarat India
Ahmadabad
GUJARAT 		 9825446242

ramyaclinic_306@yahoo.co.in 
Dr Chetan Lalseta  Shree Giriraj Multi-Specialty Hospital  Shree Giriraj Multi Speciality Hospital , A Unit of “Shree Giriraj Lifecare Private Limited”, 150ft Ring Road, 27 Navjyot Park Amin Marg Cross Road Rajkot Gujarat 360005 India
Rajkot
GUJARAT 		 9825199585

drchetanlalseta@gmail.com 
Dr Dilip Gopal Jogaikar  Shree Hospital  Department of Dermatology Siddharth Mansion Nagar Road Pune 411006 Maharashtra
Pune
MAHARASHTRA 		 9822841980

drdjogaikar@gmail.com 
Dr Shyamal Balki  Shree Hospital& Critical Care center  799, Om nagar opp. Tajshree building Sakkardara Nagpur-440009 Maharashtra
Nagpur
MAHARASHTRA 		 9730310637

drshyamalb@gmail.com 
Dr YakariVinodini  St. Theresas Hospital  Department of Clinical Research Erragadda Sanathnagar Hyderabad Telangana Hyderabad Telangana-500018
Hyderabad
TELANGANA 		 9030019699

vinskin_vy@gmail.com 
Dr Suneel Vartak  Sujata Birla Hospital & Medical Research Centre  Opposite to Bytco College Nashik Pune Highway Nashik Road Nashik, Maharashtra, 422101
Nashik
MAHARASHTRA 		 9373901829

suneel.vartak@gmail.com 
Dr Kishan Ninama  Sumandeep Vidyapeeth& Dhiraj General Hospital  Department of Skin & VD, Sumandeep Vidyapeeth & Dhiraj General Hospital, At & Po. Piparia, Ta. Waghodia, Dist- Vadodara-391760, Gujarat, India
Vadodara
GUJARAT 		 9099025287

drkishanninama.dermatologist@gmail.com 
 
Details of Ethics Committee
Modification(s)  
No of Ethics Committees= 20  
Name of Committee  Approval Status 
Amena khatun hospital Ethics committee  Approved 
Ethics committee  Approved 
Ethics committee   Approved 
Ethics committee   Approved 
Ethics committee  Approved 
Ethics Committee  Approved 
Ethics committee of Calcutta National medical college   Approved 
Ethics committee Sanjeevan hospital   Approved 
Ethics committee St. Theresas hospital  Approved 
Institutional Ethics committee  Approved 
Institutional Ethics committee  Approved 
Kanoria Ethics Committee  Approved 
Lotus Ethics Committee  Approved 
LPR Ethics Committee  Approved 
Magna Care Ethics committee  Approved 
Nirmal Hospital Ethics Committee  Approved 
Shree Giriraj hospital Research Ethics committee  Approved 
Shree Hospital Ethics committee  Approved 
Sumandeep vidyapeeth Institutional Ethics Committee  Approved 
Yash Society Ethics committee  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Approved/Obtained 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: L99||Other disorders of skin and subcutaneous tissue in diseases classified elsewhere,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  Adapalene 0.1% and Benzoyl Peroxide 2.5% Topical Gel  Adapalene 0.1% and Benzoyl Peroxide 2.5% Topical Gel(Test)is Manufactured by BELUPO Pharmaceuticals and Cosmetics Incorporated 
Comparator Agent  Epiduo Gel (Adapalene 0.1% and Benzoyl Peroxide 2.5%)  Group II (Reference): Epiduo Gel (Adapalene 0.1% and Benzoyl Peroxide 2.5%) (Reference) is Manufactured by Galderma (European Union) 
Comparator Agent  Placebo  Group-III: Placebo is Manufactured by BELUPO Pharmaceuticals and Cosmetics, Incorporated 
 
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 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

 
 
ExclusionCriteria 
Details  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.
4. 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.
11. 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.
 
 
Method of Generating Random Sequence   Computer generated randomization 
Method of Concealment   Centralized 
Blinding/Masking   Participant, Investigator and Outcome Assessor Blinded 
Primary Outcome  
Outcome  TimePoints 
Mean percent change from baseline to week 12 (day 84) in the inflammatory (papules and pustules) lesion count.
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  
Outcome  TimePoints 
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).
 		 Visit 1,2,3,4&5 
 
Target Sample Size   Total Sample Size="650"
Sample Size from India="650" 
Final Enrollment numbers achieved (Total)= "650"
Final Enrollment numbers achieved (India)="650" 
Phase of Trial   Phase 3 
Date of First Enrollment (India)   16/12/2019 
Date of Study Completion (India) 09/06/2020 
Date of First Enrollment (Global)  Date Missing 
Date of Study Completion (Global) Date Missing 
Estimated Duration of Trial   Years="0"
Months="6"
Days="0" 
Recruitment Status of Trial (Global)
Modification(s)  		 Not Applicable 
Recruitment Status of Trial (India)  Completed 
Publication Details
Modification(s)  		 None Yet 
Individual Participant Data (IPD) Sharing Statement

Will individual participant data (IPD) be shared publicly (including data dictionaries)?  

Brief Summary
Modification(s)  

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.

 
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