This Study will evaluate the therapeutic equivalence and safety of topical Tretinoin cream in comparison to marketed product Retin-A® (Tretinoin) cream in males and nonpregnant, non-lactating female subjects with acne vulgaris.
Scientific Title of Study
A randomized, multicenter, double blind, three arm, placebo controlled, parallel group, comparison study to evaluate the efficacy and safety of topical Tretinoin cream 0.025 Percent and Retin-A® (tretinoin) cream 0.025 Percent in males and nonpregnant, non-lactating female subjects with acne vulgaris [Group I (Test): Tretinoin Cream, 0.025 Percent; Group II (Reference): Retin-A® (tretinoin) Cream, 0.025 Percent; and Group III: Placebo]
Trial Acronym
Tretinoin
Secondary IDs if Any
Secondary ID
Identifier
CR222-24 Version No. 1.0 Protocol Date 01-JUN-2024
Protocol Number
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
Name
Dr Subhra Lahiri
Designation
Senior Vice President
Affiliation
AXIS Clinicals Ltd
Address
AXIS Clinicals Ltd
1-121/1, Miyapur, Hyderabad
Hyderabad TELANGANA 500049 India
Phone
04040408064
Fax
040-40408060
Email
Subhra.L@axisclinicals.com
Details of Contact Person Scientific Query
Name
Dr Subhra Lahiri
Designation
Senior Vice President
Affiliation
AXIS Clinicals Ltd
Address
AXIS Clinicals Ltd
1-121/1, Miyapur, Hyderabad
Hyderabad TELANGANA 500049 India
Phone
04040408064
Fax
040-40408060
Email
Subhra.L@axisclinicals.com
Details of Contact Person Public Query
Name
Dr Subhra Lahiri
Designation
Senior Vice President
Affiliation
AXIS Clinicals Ltd
Address
AXIS Clinicals Ltd
1-121/1, Miyapur, Hyderabad
Hyderabad TELANGANA 500049 India
Phone
04040408064
Fax
040-40408060
Email
Subhra.L@axisclinicals.com
Source of Monetary or Material Support
Nil
Primary Sponsor
Name
Aurobindo Pharma Limited
Address
Aurobindo Pharma Limited
APL Research Centre-II
Sy No. 71&72, Indrakaran (V),
Kandi (M), Sangareddy Dist -502329, Telangana, India
Type of Sponsor
Pharmaceutical industry-Global
Details of Secondary Sponsor
Name
Address
AXIS Clinicals Ltd
AXIS Clinicals Ltd
1-121/1, Miyapur
Hyderabad 500049, India
Countries of Recruitment
India
Sites of Study
No of Sites = 24
Name of Principal
Investigator
Name of Site
Site Address
Phone/Fax/Email
Dr Khushbu Prajapati
Anand surgical hospital pvt. Ltd.
Anand surgical hospital PVT. Ltd., Clinical research department, Memco crossroad, Naroda road, Naroda, Ahmedabad-382345, Gujarat Ahmadabad GUJARAT
8866770916
drkhushbuprajapati.research@gmail.com
Dr Shyamanta Barua
Assam Medical College and Hospital
Assam Medical College and Hospital, Department of dermatology, OPD complex, room number 8, AMC Rd, Barbari, Dibrugarh 786002, Assam Dibrugarh ASSAM
9435546944
drshyamanta@gmail.com
Dr Saswati Halder
Calcutta School of Tropical Medicine
Calcutta School of Tropical Medicine, Clinical research department, Ground floor, Research Room, 108, Chittaranjan Avenue, Kolkata-700073, West Bengal Kolkata WEST BENGAL
9434427717
saswatihalder32@gmail.com
Dr Laxman Salwe
Care Multispeciality Hospital
Care Multispecialty Hospital, Clinical research department 2nd floor, Kolte Arcade, Pune Nagar Road, Wagholi, Pune-412207, Maharashtra Pune MAHARASHTRA
9028092738
salwelaxman030@gmail.com
Dr Patil Sharmila Pandharinath
D.Y. Patil Medical college Hospital and research center
D.Y. Patil Medical college Hospital and Research centre, medical college building 5th floor, clinical research unit, Sector-5, Nerul, Navi Mumbai, 400706, Maharashtra Mumbai MAHARASHTRA
8850635503
drsharmilapatil@gmail.com
Dr Ashish Ramachandrarao Deshmukh
Darakh Nursing Home & Kidney Stone Centre
Darakh Nursing Home & Kidney Stone Centre, Clinical research department room basement, Raghuveer Nagar, Jalna Road, Aurangabad-431001, Maharashtra Aurangabad MAHARASHTRA
9422213292
ashish7557@gmail.com
Dr Saurabh Kapadia
Divine Multispeciality Hospital
Divine Multispecialty Hospital, Clinical research department, 2nd -3rd floor Shikshapatri sky court, near swagat flamingo, sargasan, Gandhinagar-382421, Gujarat Gandhinagar GUJARAT
9824261031
drsaurabhkapadia@yahoo.com
Dr Italiya Vivek bhai nathabhai
Global Hospital
Global Hospital, Clinical research department, 4th floor, Global point, near Navjivan restaurant, Sarthana Jakatnaka, Surat-395006, Gujarat, Surat GUJARAT
9016961154
globalhospitalcr@gmail.com
Dr Richa Gupta
Health 1 super speciality hospital
Health 1 super specialty hospital, Clinical research department, 1st floor room number 5, Ahmedabad Near Venitian Villa, Shilaj Circle, S.P Ring Road, Thaltej, Ahmedabad-380059, Gujrat Ahmadabad GUJARAT
9879245064
drricha08.gupta@gmail.com
Dr Abheek Sil
Health point hospital
Health point hospital, Clinical research department, 21 Prannath Pandit Street, Opposite of Lansdown Padmapukur, Kolkata-700025, West Bengal Kolkata WEST BENGAL
8017041218
abheek.sil@gmail.com
Dr Farheen Sultana Chand
Hindu Mission Hospital
Hindu Mission Hospital, Main block, Ground floor, OPD room number 22, No 103, GST Road, West Tamabaram, Chennai-600045, Tamil Nadu Chennai TAMIL NADU
7010509441
farheenderma@gmail.com
Dr H Bangaru
K.R. Hospital
K.R. Hospital, Mysore medical College and research Institute, Department of dermatology, Clinical research room Mysore-57000, Karnataka Mysore KARNATAKA
9886789231
drbangaruskin@gmail.com
Dr Namrata C Manjunath
Kempegowda Institute of Medical Science Hospital and Research Center
Kempegowda institute of medical science Hospital and research center, Department of Dermatology, Clinical research room, KR Road, VV Puram, Bangalore-560004, Karnataka Bangalore KARNATAKA
8105510127
drnamratacmanjunath@gmail.com
Dr Mitanjali Sethy
KIMS Hospital
KIMS Hospital, Kushabhadra Campus (KIIT Campus-5), D block, 6th floor room number 607, Clinical research Department, Patia, Bhubaneswar-751024, Odisha Khordha ORISSA
LMMFs Deenanath Mangeshkar Hospital & Research Centre
LMMFs Deenanath Mangeshkar Hospital & Research Centre, Clinical research Department 2nd floor new building, Erandwane, Pune-411004, Maharashtra Pune MAHARASHTRA
9822400964
drpvaidya@gmail.com
Dr Krishna Deb Barman
Maulana Azad Medical College associated Lok Nayak Hospital
Maulana Azad Medical College associated Lok Nayak Hospital, Department of Dermatology, Clinical research room, 2, Bahadur Shah Zafer Marg, New Delhi- 110002 New Delhi DELHI
9868961716
krishna.debbarman@gmail.com
Dr Ramesh Chandra Gharami
Medical College and Hospital
Medical College and Hospital, Department of Dermatology,3rd floor, room number 412, OPD building research room, 88, College Street, Kolkata -700073, West Bengal Kolkata WEST BENGAL
9434173114
rameshgharami8@gmail.com
Dr Arun Achar
Nil Ratan Sircar Medical College and Hospital
Nil Ratan Sircar Medical College and Hospital, Department of Dermatology, 1st floor OPD building, Clinical research room number 205 138, AJC Bose Road, Kolkata-700014, West Bengal Kolkata WEST BENGAL
9434017410
achararun@rediffmail.com
Dr Patil Mamta Rajendra
Ojas Multispeciality Hospital
Ojas Multispeciality Hospital, Ground floor Clinical research Department, Sr.no.203/1, Bhondave chowk, D Y Patil college road, Ravet, Pune-412101, Maharashtra Pune MAHARASHTRA
7738927929
dr.mamta.ojas@gmail.com
Dr Shyamal Balki
Shree Hospital & Critical Care Centre
Shree Hospital & Critical Care Centre 799, 3rd floor clinical research department, Om Nagar, opp Taj Shree Building, Sakkardara sq. Nagpur- 440009, Maharashtra Nagpur MAHARASHTRA
9665477444
drshyamalb@gmail.com
Dr Ashutosh Mehta
Triveni PolyClinic
Triveni PolyClinic, Clinical research department, 101, first floor, plot no. 19-A, Shreejee Krupa near wardhaman nagar, petrol pump, Nagpur-440008, Maharashtra Nagpur MAHARASHTRA
9766008271
drmehtaskin@gmail.com
Dr Srinivas K
Udhbhava Hospital
Udhbhava Hospital, Clinical research department, #144, 100ft ring road, Ittamadu, Banashankari 3rd stage, Bangalore-560085, Karnataka Bangalore KARNATAKA
9739006755
srinivaskonappalli4644@gmail.com
Dr Hade Sandeep Bhagwatrao
Vedant Multispeciality Hospital
Vedant Multispeciality Hospital, Clinical research department, Ground floor, GP 83, Opp. Rotary club, Sambhaji Nagar, MIDC, Chinchwad, Pune- 411019, Maharashtra Pune MAHARASHTRA
9403322541
drsandeephade.vedant@gmail.com
Details of Ethics Committee
No of Ethics Committees= 24
Name of Committee
Approval Status
Anand Surgical Hospital IEC
Approved
Care Multispeciality Hospital Ethics Committee
Approved
Clinical Research Ethics Committee, School of Tropical Medicine
Approved
Divine Ethics Committee
Approved
Ethics Committee Ajanta Super speciality Hospital
Approved
Ethics Committee NRS Medical college
Submittted/Under Review
Global Ethics Committee
Approved
Health 1 super speciality hospital Ethics Committee
Approved
HEALTH POINT ETHICS COMMITTEE
Approved
Hindu Mission Hospital Institutional Ethics Committee
Approved
IEC Vedant Multispeciality Hospital
Approved
IEC-MMC and RI and Associated Hospital
Submittted/Under Review
Institutional Ethics Committee Assam Medical College
Approved
Institutional Ethics Committee for Human Research
Submittted/Under Review
Institutional Ethics Committee MAMC Maulana Azad Medical College
Submittted/Under Review
Institutional Ethics Committee, D Y Patil Medical College
Approved
Institutional Ethics Committee, Deenanath Mangeshkar Hospital & Research Centre
Submittted/Under Review
Institutional Ethics Committee-KIMS
Approved
KIMS Institutional Ethics Committee
Approved
Ojas Multispeciality Hospital Ethics Committee
Approved
Shah Lifeline Hospital and Heart Institute Ethics Committee
Approved
Shree Hospital Ethics Committee
Approved
Sri Durgamba Independent Ethics Committee
Approved
Triveni Polyclinic Institutional 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
Comparator Agent
Placebo
Dose: half inch or less of medication onto a fingertip (approximately 0.5 to 1 gram)
Route of administration: Topical use only
Frequency: Once daily at bedtime
Total Duration: 84 days.
Comparator Agent
Retin-A® (tretinoin) Cream, 0.025%
Dose: half inch or less of medication onto a fingertip (approximately 0.5 to 1 gram)
Route of administration: Topical use only
Frequency: Once daily at bedtime
Total Duration: 84 days.
Intervention
Tretinoin cream 0.025 Percent
Dose: half inch or less of medication onto a fingertip (approximately 0.5 to 1 gram)
Route of administration: Topical use only
Frequency: Once daily at bedtime
Total Duration: 84 days.
Inclusion Criteria
Age From
12.00 Year(s)
Age To
40.00 Year(s)
Gender
Both
Details
1 Healthy male or non-pregnant and non-lactating female aged between Greater than or equal to 12 and less than or equal to 40 years with a clinical diagnosis of acne vulgaris.
2.Subject having greater than or equal to 25 non-inflammatory lesions i.e., open and closed comedones and greater than or equal to 20 inflammatory lesions i.e., papules and pustules and less than or equal to 2 nodulocystic lesions i.e., nodules and cysts at baseline on the face.
3.Subject having clinical diagnosis of acne vulgaris severity grade 2, 3, or 4 as per IGA scale in Appendix-3.
4.Subject must be willing to refrain from use of all other topical products moisturizer, new brands of make-up, creams, lotions, powders or any other treatment period other than the investigational products.
5.Subjects and LAR applicable for adolescents’ subjects willing to give their written informed consent in case of subject with age greater than or equal to 18 years and written informed assent in case of subject greater than or equal to 12 years and less than 18 years to participate in the study.
6.Female of childbearing potential, willing to use an acceptable form of birth control during the study.
•Tubal sterilization tubal ligation performed more than one month before Study Day 1 transcervical tubal occlusion procedure performed more than six months before Study Day 1
•Intrauterine Device IUD
•Two barrier methods used together cervical cap, diaphragm contraceptive sponge, or vaginal spermicide plus a male or female condom
•Absolute sexual abstinence no sexual intercourse or genital contact with a male partner during the study conduct
7.Male subject must agree to use accepted methods of birth control with their partners, from the day of the first dose administration to 07 days after the last administration of IP.
8.Subject who uses make-up must have used the same brands/types of make-up for a minimum period of 14 days prior to study entry and must agree to not change make-up brand/type or frequency of use throughout the study
ExclusionCriteria
Details
1.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.
2.Subject having excessive facial hair e.g. beards, sideburns, moustaches etc. that would interfere with diagnosis or assessment of acne vulgaris
3. Subject with history of hypersensitivity or allergy to Tretinoin, retinoids and/or any of study medication ingredients.
4.Subject with a significant medical history of or are currently immunocompromised or receiving immunomodulators/ biologics since last 3 months.
5.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.
6.Subject used estrogens or oral contraceptives or any other hormonal therapy for less than 3 months prior to baseline; use of such therapy must remain constant throughout the study.
7.Subject used cryodestruction or chemodestruction, dermabrasion, photodynamic therapy, acne surgery, any facial surgery, intralesional steroids, or x-ray therapy on face within 1 month prior to baseline or planning to use during the study.
8. Subject used spironolactone, 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.
9. 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.
10.Subject who engages in activities that involve excessive or prolonged exposure to sunlight or weather extremes, such as wind or cold.
11.Subject who is using preparations containing sulfur, resorcinol, or salicylic acid.
12.Subjects who could not be able to read and write.
13.Subject who had participated in another investigational drug or device research study within 90 days of enrolment.
14.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.
15.Female subject who is pregnant, nursing or planning a pregnancy during the study.
16.Subject with known history of HIV, HBsAg and HCV.
Method of Generating Random Sequence
Computer generated randomization
Method of Concealment
Centralized
Blinding/Masking
Participant and Investigator Blinded
Primary Outcome
Outcome
TimePoints
Mean percent change from baseline to week 12 in the inflammatory papules and pustules lesion count.
Mean percent change from baseline to week 12 in the non-inflammatory open and closed comedones lesion count.
Week 4, Week 8 and Week 12
Secondary Outcome
Outcome
TimePoints
Proportion of subjects with a clinical response of success at week 12
Proportion of subjects with a clinical response of success at week 12
Target Sample Size
Total Sample Size="980" Sample Size from India="980" Final Enrollment numbers achieved (Total)= "Applicable only for Completed/Terminated trials" Final Enrollment numbers achieved (India)="Applicable only for Completed/Terminated trials"
Phase of Trial
Phase 3
Date of First Enrollment (India)
10/07/2025
Date of Study Completion (India)
Applicable only for Completed/Terminated trials
Date of First Enrollment (Global)
Date Missing
Date of Study Completion (Global)
Applicable only for Completed/Terminated trials
Estimated Duration of Trial
Years="1" Months="0" Days="0"
Recruitment Status of Trial (Global)
Not Applicable
Recruitment Status of Trial (India)
Not Yet Recruiting
Publication Details
N/A
Individual Participant Data (IPD) Sharing Statement
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
Brief Summary
1.This is a double blind, randomized, parallel, three arm, placebo-controlled, multicentric study of topical Tretinoin Cream 0.025% and Retin-A Cream 0.025% in the treatment of AV.
2.A total of five visits will be scheduled to the Investigators site i.e., Screening/Randomization/Baseline Visit i.e visit 1: Day -2/Day -1 to Day 1; and three On-treatment Visits i.e visit 2, 3 and 4: Day 15, Day 29, and Day 57 and End of Treatment EOT visit i.e visit 5: Day 85. There will be a window period of plus or minus 4 days after the start of treatment for visit 2, 3, 4 and 5. An additional telephonic follow-up visit will be conducted after 7 days of EOT visit with a window period of plus or minus 2 days for assessing safety. The total duration for each subject will be a maximum of 96 Days. If the subjects have completed all the screening assessment procedures and were eligible for randomization either on Day-2 or Day -1, then the subjects can be randomized on the same day and will be instructed to start the medication application from this day or subsequent day. Day 1 will be accounted from the start of application of study medication.
3.On visit 1, subjects will be explained about the study and an Informed Consent Form will be obtained from subjects aged greater than or equal to 18 years and from parents of subjects aged less than 18 years. Informed Assent Form will be obtained from subjects aged greater than or equal to 12 years and less than 18 years in addition to ICF obtained from parents. After signing the ICF/ IAF, subjects will complete the screening procedures such as obtaining demographics, medical and medication history, evaluation of general and systemic examination, vital signs examination, urine pregnancy test females of childbearing potential, lesion count assessment, application site evaluation* and Investigator’s Global Assessment IGA. Concomitant medication, and adverse event recording will be performed.
All eligible subjects will be randomly assigned in 2:2:1 ratio to one of the three treatment groups in double blinded manner after review of inclusion/exclusion criteria by assessing lesion count and IGA. Subjects will be dispensed with investigational product (IP) and non-medicated cleanser and sunscreen with SPF (equal or greater than 50) along with instructions on application and shall be instructed not to open the IP at the study site. Subjects will be provided with a diary to record application details of IP, adverse events, side effects, and concomitant medication details. Any additional application and missed applications shall also be noted in the subject diary. Subjects will be instructed regarding prohibited medications and procedures during the study. Subjects will be instructed to apply the IP once daily at bedtime starting from Day 1.
4.Subjects will be requested to return to site for three evaluation visits visit 2: Day 15, visit 3: Day 29 and visit 4: Day 57 with window period of plus or minus 4 days for each visit, for efficacy and safety assessments. Subjects will be dispensed with new IP on Day 29 and Day 57 and collect the IP tube dispensed at Day 1 on Day 29 and at Day 29 on Day 57, respectively. Subjects will be instructed to bring subject diary on all these visits for evaluation of treatment compliance.
5.Application site reactions erythema, dryness, burning/stinging, erosion, edema, pain, and itching will be evaluated using 4-point scale will be assessed at each post study treatment application visit.
6.Subjects will be instructed to return to the study site on Day 85 plus or minus 4 for final assessments. General and Systemic examination, vital signs recording, urine pregnancy test for females of childbearing potential, concomitant medication, and adverse event recording will be performed. Efficacy evaluation will be done by assessing lesion count and application site reaction assessments will also be evaluated. Subjects will be requested to return the issued IP and subject diaries for compliance checking.
7.Subjects will be followed up telephonically 7 days plus or minus 2 days End of study/ Safety follow-up visit after the end of the treatment visit.
If it is necessary to see a subject other than a scheduled visit date, the unscheduled visit procedures shall be followed. If the Investigator decides to discontinue a subject at any time during the study, a standard care of treatment shall be advised at the investigator’s discretion and an early termination visit shall be performed for this purpose.