CTRI

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CTRI Number

CTRI/2025/12/098453 [Registered on: 04/12/2025] Trial Registered Prospectively

Last Modified On:

07/02/2026

Post Graduate Thesis

Type of Trial

PMS

Type of Study

Other (Specify)

Study Design

Single Arm Study

Public Title of Study

A Multicenter observational study on the effectiveness and tolerability of Hexilak® Acne scar serum used with device-based procedures for acne scar treatment (Adjuvant Real-World Evidence Study).

Scientific Title of Study

Prospective, observational multicenter Study for effectiveness and tolerability of Hexilak acne scar serum when used along with device-based procedures (Adjuvant Study for Acne Scar Treatment- Understanding Real-world Evidence)

Trial Acronym

NIL

Secondary IDs if Any

Secondary ID	Identifier
NIL	NIL

Details of Principal Investigator or overall Trial Coordinator (multi-center study)

Name	Dr TD Rajan
Designation	Principal investigator
Affiliation	Dr. T. D. Rajans Clinic
Address	102-B, SAMROCK APT, JUHU LANE OFF S.V ROAD Mumbai (Suburban) MAHARASHTRA 400058 India
Phone	9821024437
Fax
Email	skinbeautydoc@gmail.com

Details of Contact Person
Scientific Query

Name	Dr TD Rajan
Designation	Principal investigator
Affiliation	Dr. T. D. Rajans Clinic
Address	102-B, SAMROCK APT, JUHU LANE OFF S.V ROAD Mumbai (Suburban) MAHARASHTRA 400058 India
Phone	9821024437
Fax
Email	skinbeautydoc@gmail.com

Details of Contact Person
Public Query

Name	Dr TD Rajan
Designation	Principal investigator
Affiliation	Dr. T. D. Rajans Clinic
Address	102-B, SAMROCK APT, JUHU LANE OFF S.V ROAD Mumbai (Suburban) MAHARASHTRA 400058 India
Phone	9821024437
Fax
Email	skinbeautydoc@gmail.com

Source of Monetary or Material Support

Menarini India Private Limited

Primary Sponsor

Name	Menarini India Private Limited
Address	2102, Tower 3, Indiabulls Finance Center, Senapati Bapat Marg, Elphinstone Rd (W), Mumbai 400013, India.
Type of Sponsor	Pharmaceutical industry-Indian

Details of Secondary Sponsor

Name	Address
NIL	NIL

Countries of Recruitment

India

Sites of Study
Modification(s)

No of Sites = 42
Name of Principal Investigator	Name of Site	Site Address	Phone/Fax/Email
Dr Nikita Jadhav	Advance Skin Health Clinic	13/11, Hilla Towers Dr SS Marg, Bharat Rice Mil Compound, Lalbaug, Mumbai 400012 Mumbai MAHARASHTRA	9152449038 dr.nikitasjadhav@gmail.com
Dr Mohammed Ismail Shaikh	Aesthederm Dr. Ismail Shaikh Colaba Skin and Laser Clinic	7/23, A, Grants Building, Road, Colaba, Mumbai 400005 Mumbai MAHARASHTRA	7028080600 dermis1@gmail.com
Dr Ish Anand	Anand skin and dental clinic	12,BASEMENT,NAJAFGARH ROAD, NANGLOI, Delhi-110041 New Delhi DELHI	9999284846 skincarddrish@gmail.com
Dr Vinay Gowda	Animisha Dermatology	Mahalakshmi Puram, Bangalore 560086 Bangalore KARNATAKA	9900146376 askadssc@gmail.com
Dr Nipun Jain	Aura Skin Cosmetology Clinic	221, DDA SFS FLATS, SECTOR-9, POCKET-1, DWARKA, Delhi- 110075 New Delhi DELHI	9811542371 jain_atharv@yahoo.co.in
Dr Gaurav Nakra	Centre For Skin	178-BASEMENT,SAINI ENCLAVE,, KARKARDOOMA, Delhi - 110092 New Delhi DELHI	9711374342 nakra.doc@gmail.com
Dr Nethravathy A R	Chandre ENT And Derma Care	No 76/C, manganahalli cross, ullal main road,, 70, Ullal Main Rd, next to Mobile Tower, Sir M Vishveswaraya Layout, Jnana Ganga Nagar, Bengaluru, Karnataka 560110 Bangalore KARNATAKA	9482552666 chandruucare@gmail.com
Dr Nithya Raghunath	Contura Clinic	3C, 950, 3rd Cross Rd, HRBR Layout 1st Block, HRBR Layout, Kalyan Nagar, Bengaluru, Karnataka 560043 Bangalore KARNATAKA	9623735005 nityareddy85@gmail.com
Dr Jijith	Cosmalife Skin Clinic	Nagdevanahalli, Banglore- 560056 Bangalore KARNATAKA	9446888000 drjijith888000@gmail.com
Dr Rohit Batra	Derma world skin and Hair	Rajory Garden Delhi-110027 New Delhi DELHI	9891298478 drrohitbatra@gmail.com
Dr Alka Goel	Dr. Alka Goel’s Skin and Laser Clinic	BE 329, 1st floor, Gali no 3, and, opposite Vatika Apartments, near Ramji di hatti, Hari Nagar, Delhi, 110064 New Delhi DELHI	9650073264 dr.alkagoel@gmail.com
Dr TD Rajan	Dr. Rajan T. Ds Clinic	102-B, SAMROCK APT, JUHU LANE OFF S.V ROAD 400058 Mumbai (Suburban) MAHARASHTRA	9821024437 skinbeautydoc@gmail.com
Dr Roshan Kumar B	Dr. Roshans skin clinic	1st floor SJ Arcade above Ibaco icecream shop Whitefield Main Road Bengaluru-560066 Bangalore KARNATAKA	9379615675 reddyros@gmail.com
Dr Vivek M Pai	Experia Advanced Skin And Hair Clinic	300mtr from vajarahalli metro station, 3484, 80 Feet Rd, behind Hotel Udupi Upahara, near KSIT engineering college, 4th H block, Raghuvanahalli, Subramanyapura, Bengaluru, Karnataka 560109 Bangalore KARNATAKA	9844752607 vpai90@gmail.com
Dr Priyal Gala	Gala Skin and Hair Clinic	Kakad Estate, Sagar darshan CHS, Office No.8, Dr RG Thadani Mard, B wing Siddharth Nagar, Worli 400018 Mumbai MAHARASHTRA	8451872948 pryl.ghalla@gmail.com
Dr Rashmi Mahajan	GnR Skin and Heart Clinic	22/142, Vikram Vihar, Lajpat Nagar- 4, Near gate no. 15, Close to Moolchand Metro Station. New Delhi DELHI	9540071071 rashmigaurav2901@gmail.com
Dr Alka Gupta	Gupta Skin Clinic	Block, C2D Rd, C-2 D Block, 1A, Janakpuri, New Delhi, Delhi, 110058 New Delhi DELHI	9810065530 dralkagupta6@gmail.com
Dr Raina Nahar	Kaizen Skin Clinic	Church, 1101-A, 11th Floor, Suvidha Square Junction of S.V. Road and Caeser Road, Beside Amboli, Andheri West 400058 Mumbai (Suburban) MAHARASHTRA	9595111022 rainaharkaizen@gmail.com
Dr Rashmi Sharma	KARA Dermatology Solutions and Aesthetic Centre	B-11/8034, Vasantkunj, New Delhi- 110070 New Delhi DELHI	9560057483 rashmi1669@gmail.com
Dr Santhosh Krishna Shetty	Kolebail Derma Clinic	Basaveshwarnagar, Bengaluru, Karnataka 560058 Bangalore KARNATAKA	7411707426 dr.kolkebail@gmail.com
Dr Deepa K	Kritash Skina And Aesthetic Clinic	2nd Floor, Sarjapur - Marathahalli Rd, adjacent to Wipro, above Bank of Baroda, Kaikondrahalli, Bengaluru, Karnataka 560035 Bangalore KARNATAKA	9980596016 drdeepakrish85@gmail.com
Dr Arshdeep Kaur	Kubba Skin Clinic	10,ARADHANA ENCLAVE, SEC-13RING ROAD, R K PURAM Delhi -110066 New Delhi DELHI	7042809720 arsh_deep2003@yahoo.com
Dr Lipy Gupta	Max Multispeciality centre	N-110, Panchasheel park, New Delhi- 110017 New Delhi DELHI	9811728073 drlipygupta@gmail.com
Dr Sonal Garg	Medicutis Clinic	A- 1/19, A block, Prashant Vihar, Sec- 14, Rohini, Delhi- 110085 New Delhi DELHI	8141128116 drsonaltibrewal89@hotmail.com
Dr Pallavi Rathi	My Skin My Health	Pranik Chambers Unit No. A 407/408, A Wing, Saki Vihar Rd, opp. H.P. Petrol pump, Sag Baug, Marol, Saki Naka, Mumbai - 400072 Mumbai (Suburban) MAHARASHTRA	9930905011 drpallavir@gmail.com
Dr Snehal Sriram	Nahars Amrit Shakti	Chandivali Farm Road, Off, Saki Vihar Road, Andheri East, Mumbai 400072 Mumbai (Suburban) MAHARASHTRA	9730011181 sanghavishreyas4@gmail.com
Dr Shubha M Kesari	Nypunya Aesthetic Clinic Dermatology And Cosmetic Plastic Surgeon	Off 24th Mai & Metro Yellow Lie 3 1stcross Rd Marenahalli 2nd Phase JP Nagar Bengaluru Karnataka 560041 Bangalore KARNATAKA	9623735005 shubhakesari@gmail.com
Dr Varun Tyagi	Perfect Tyagi Hospital	78 A C BLOCK DILSHAD GARDEN, Delhi -110095 New Delhi DELHI	9873374848 perfecttyagihospital@gmail.com
Dr Rashmi Shinde	Quest Clinic	Film City Road, Goregaon East 400065 Mumbai (Suburban) MAHARASHTRA	9987416543 drrashmi.derm@gmail.com
Dr Aditi Dalvi	Renee Advanced Skin and Hair Clinic	I 08, Sai Madhuvan CHS. Sevaram, Lalwam Road, Mulund West Mumbai MAHARASHTRA	8422900309 draditivdalvi@gmail.com
Dr Shishira J	Skin Aura Clinic	182/A, 18th M. M. Road, Sector 3, HSR Layout, Bangaluru- 02 Bangalore KARNATAKA	8105471887 dr.shishiragoutham@gmail.com
Dr Usha Beloskar	Skin Savvy	4th Floor, Kohinoor Square, B-403, Opp. Shiv Sena Bhavan, Lasarwadi, Dadar, Mumbai 400028 Mumbai MAHARASHTRA	9152449038 dr.nikitasjadhav@gmail.com
Dr Preeti Shenai	Skin Work Clinic	48,BHAKTI BUNGALOW,11TH NS ROAD,OPP AROGYA NIDHI HOSPITAL,JUHU, 400049 Mumbai (Suburban) MAHARASHTRA	7715865178 drpritishenai@gmail.com
Dr Meenu Barara	Skinalaya	E-3/1 3RD FLOOR BLOCK E-3, POCKET 3 SECTOR 11 ROHINI, Delhi- 110085 New Delhi DELHI	9873455745 meenu.barara@gmail.com
Dr Sheetal Dandale	SkinConsult Clinic	201, Sunrays Shopping centre, Charkop 2, Kandivali West, Mumbai 400067 Mumbai (Suburban) MAHARASHTRA	981969636 ameetdandale@gmail.com
Dr Ashish B Shetty	Skincure- Skin And Hair Clinic	1051, DOCTORS Floor, ICICI Bank Building, Vijaybanklayout, Bangalore, Bilekahalli, 560076 Bangalore KARNATAKA	9986681582 drsohandasshetty@yahoo.co.in
Dr Neeharika Goyal	Svastam Wellness Clinic	C 38, Ashok Vihar Phae-1,Near Golden Bell School, Delhi - 110052 New Delhi DELHI	9868300211 neeharika935@gmail.com
Dr Archhana Gullur	Tatva Dermaessthetics -Skin And Hair Clin	No 282 1st Cross Jss Circle 36th Cross Rd,7th Block Jayanagar Bengaluru Karnataka 560070 Bangalore KARNATAKA	9901648738 tatva@dermatologist.i
Dr Richa Sharma	Twacha Skin Clinic	Sector 12A, Dwarka, New Delhi- 110078 New Delhi DELHI	9350524848 dr.richa1@gmail.com
Dr Amrutha H K	Vrudhii Skin Center	Hesargatta Road, Bengaluru 560073 Bangalore KARNATAKA	7975348417 hosalli.amrutha@gmail.com
Dr Shurti Chavan	Youthville Clinic	02, ground floor, Aroma Co-operating housing Socity Ltd, New Link road, oshiwara, Andheri West, Mumbai 400054 Mumbai (Suburban) MAHARASHTRA	8879412722 shruti2586@gmail.com
Dr Harsha S	Ziva Skin And Hair Clinic	Hasaragatta, Main Road, Dasarahalli, Bangalore- 560073 Bangalore KARNATAKA	9611256888 hs.chasepluti@gmail.com

Details of Ethics Committee
Modification(s)

No of Ethics Committees= 28
Name of Committee	Approval Status
ACE Independent Ethics Committee	Approved
ACE Independent Ethics Committee	Approved
ACE Independent Ethics Committee	Approved
ACE Independent Ethics Committee	Approved
ACE Independent Ethics Committee	Approved
ACE Independent Ethics Committee	Approved
ACE Independent Ethics Committee	Approved
ACE Independent Ethics Committee	Approved
ACE Independent Ethics Committee	Approved
ACE Independent Ethics Committee	Approved
ACE Independent Ethics Committee	Approved
ACE Independent Ethics Committee	Approved
ACE Independent Ethics Committee	Approved
ACE Independent Ethics Committee	Approved
CLAIMS Independent Ethics Committee	Approved
CLAIMS Independent Ethics Committee	Approved
CLAIMS Independent Ethics Committee	Approved
CLAIMS Independent Ethics Committee	Approved
CLAIMS Independent Ethics Committee	Approved
CLAIMS Independent Ethics Committee	Approved
CLAIMS Independent Ethics Committee	Approved
CLAIMS Independent Ethics Committee	Approved
CLAIMS Independent Ethics Committee	Approved
CLAIMS Independent Ethics Committee	Approved
CLAIMS Independent Ethics Committee	Approved
CLAIMS Independent Ethics Committee	Approved
CLAIMS Independent Ethics Committee	Approved
GOOD SOCIETY Ethical Research	Approved

Regulatory Clearance Status from DCGI

Status

Not Applicable

Health Condition / Problems Studied

Health Type	Condition
Healthy Human Volunteers	Acne Scar

Intervention / Comparator Agent

Type	Name	Details
Intervention	Hexilak acne scar serum	Once or Twice daily as directed by Investigator for 90 days

Inclusion Criteria

Age From	18.00 Year(s)
Age To	45.00 Year(s)
Gender	Both
Details	1) Healthy participants of either gender from 18-45 years of age after assessing medical history, physical examination and clinical judgment of the investigator. 2) Participants are diagnosed clinically with acne scars with or without hyperpigmentation. 3) Participants who have not undergone any scar treatment in the past 6 months. 4) Willing to refrain from use of all other topical medications as per Investigator discretion, that will significantly affect the study results. the use of other cosmetic products on face during the course of the study. 5) Cooperating, informed of the need and duration of the examinations, and ready to comply with protocol procedures. 6) Having signed a Consent Form, after being informed orally and in writing of all information concerning the study procedures and study objectives.

ExclusionCriteria

Details

1) Pregnant women or lactating women.
2) Participants with a history of allergic dermatitis or contact allergy to cosmetics, with known sensitivity to any of the ingredients in the study product.
3) Presence of any other skin conditions, diseases, or medical conditions in the investigators opinion might require concurrent therapy and interfere with the evaluation of the study medication or compromise patients safety.

Method of Generating Random Sequence

Not Applicable

Method of Concealment

Not Applicable

Blinding/Masking

Not Applicable

Primary Outcome

Outcome	TimePoints
Evaluate percentage of subjects showing improvement in acne scars on Physician Global Aesthetic Improvement Scale	Day 90

Secondary Outcome

Outcome	TimePoints
Percentage of subjects showing improvement in acne scars on Physician Global Aesthetic Improvement Scale.	Day 30
Mean change in Physician Global Aesthetic Improvement Scale at all follow up of treatment visits.	Day 30, Day 60, and Day 90
Percentage of subjects showing improvement in acne scars on Subject Global Aesthetic Improvement Scale at all follow up of treatment visits.	Day 30, Day 60, and Day 90
Mean change in Subject Global Aesthetic Improvement Scale at all follow up of treatment visits.	Day 30, Day 60, and Day 90
Mean change in Post Acne Hyperpigmentation Index as compared to baseline.	Day 1, Day 30, Day 60, and Day 90
Percentage of subjects on Subject satisfaction score.	Day 30, Day 60, and Day 90

Target Sample Size

Total Sample Size="500"
Sample Size from India="500"
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

N/A

Date of First Enrollment (India)

15/12/2025

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 Yet Recruiting

Recruitment Status of Trial (India)

Open to Recruitment

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

This study is a prospective clinical investigation designed to evaluate the efficacy and safety of an acne scar serum in healthy participants with post-acne scarring. After obtaining informed consent, baseline assessments including demographics, urine pregnancy test (for females), digital facial photographs, and post-acne hyperpigmentation scoring will be performed. Participants will apply the assigned acne scar serum as instructed.

Follow-up visits will be conducted on Day 30, Day 60, and Day 90. At each visit, standardized digital photographs will be captured, and acne scars will be assessed using the Physician Global Aesthetic Improvement Scale and the Subject Global Aesthetic Improvement Scale. Post-acne hyperpigmentation score and subject satisfaction score will also be recorded. Concomitant treatments and any adverse events will be monitored throughout the study. The study aims to determine improvement in acne scarring and hyperpigmentation with regular use of the acne scar serum over 90 days.