| CTRI Number |
CTRI/2025/04/084270 [Registered on: 07/04/2025] Trial Registered Prospectively |
| Last Modified On: |
27/01/2026 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug |
| Study Design |
Randomized, Parallel Group, Placebo Controlled Trial |
|
Public Title of Study
|
A Study to Test the Safety and Effectiveness of SCD-153 for Hair Loss (Alopecia Areata) |
|
Scientific Title of Study
|
A Randomized, Double-Blind, Vehicle-Controlled Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Efficacy of Topically Applied SCD-153 in Patients With Alopecia Areata |
| Trial Acronym |
NIL |
Secondary IDs if Any
Modification(s)
|
| Secondary ID |
Identifier |
| SCD-153-24-01, A2-12-Jun-2025 |
Protocol Number |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Mudgal Kothekar |
| Designation |
Vice President, Clinical Development |
| Affiliation |
Sun Pharma Advanced Research Limited |
| Address |
17B, Mahal Industrial Estate, Mahakali Caves Road, Andheri (E)
Mumbai
MAHARASHTRA
400093
India |
| Phone |
66455645 |
| Fax |
|
| Email |
clinical.trials@sparcmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Mudgal Kothekar |
| Designation |
Vice President, Clinical Development |
| Affiliation |
Sun Pharma Advanced Research Limited |
| Address |
17B, Mahal Industrial Estate, Mahakali Caves Road, Andheri (E)
MAHARASHTRA
400093
India |
| Phone |
66455645 |
| Fax |
|
| Email |
clinical.trials@sparcmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Mudgal Kothekar |
| Designation |
Vice President, Clinical Development |
| Affiliation |
Sun Pharma Advanced Research Limited |
| Address |
17B, Mahal Industrial Estate, Mahakali Caves Road, Andheri (E)
MAHARASHTRA
400093
India |
| Phone |
66455645 |
| Fax |
|
| Email |
clinical.trials@sparcmail.com |
|
|
Source of Monetary or Material Support
|
| Sun Pharma Advanced Research Company Limited 17B, Mahal Industrial Estate, Mahakali
Caves Road, Andheri (E) Mumbai MAHARASHTRA 400093 India |
|
|
Primary Sponsor
|
| Name |
Sun Pharma Advanced Research Company Limited |
| Address |
17B, Mahal Industrial Estate, Mahakali
Caves Road, Andheri (E) Mumbai MAHARASHTRA 400093 India |
| Type of Sponsor |
Pharmaceutical industry-Global |
|
|
Details of Secondary Sponsor
|
|
|
Countries of Recruitment
|
India |
Sites of Study
Modification(s)
|
| No of Sites = 18 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr Neetu Sidana |
Apex Hospitals Pvt Ltd |
Room No: 01
Division: Basement, OPD No.1
Department :OPD
Jaipur
RAJASTHAN |
91 9929380108
drneetusidana95@gmail.com |
| Dr Suneel Vartak |
Assured Care Plus Hospital |
Room No: NA
Division: 4th & 5th Floor
Department : Dermatology
Nashik
MAHARASHTRA |
0253 246 8786
suneel.vartak@gmail.com |
| Dr Saswati Halder |
Calcutta School of Tropical Medicine |
Room No:OPD
Division: Ground Floor
Department : Dermatology
Kolkata
WEST BENGAL |
033-2212 3695
saswatihalder32@gmail.com |
| Dr B S Chandrashekar |
CUTIS Academy of Cutaneous Sciences (CACS) |
Room No: 5/1
Department: Dermatology
Division: Dermatosurgery
Bangalore
KARNATAKA |
91-8023401200
clinicaltrials@cutis.org.in |
| Dr Ramesha Bhat |
Father Muller Medical College Hospital |
Room No: 65
Department: Department of Dermatology, Venereology and Leprosy
Division: Dermatology
Dakshina Kannada
KARNATAKA |
0824-2238000
crcfmrc3@fathermuller.in |
| Dr Krina Patel |
GMERS Medical College & Civil Hospital |
Room No:202-Second Floor
Department: Dermatology
Division : Skin
Ahmadabad
GUJARAT |
91-79-23221931
drkbpatel66@yahoo.com |
| Dr Dev Prakash Shivhare |
GSVM Medical College |
Room No:PI OPD
Division: Ground Floor
Department : Dermatology
Kanpur Dehat
UTTAR PRADESH |
91-512-2535483
drdev.derma@gmail.com |
| Dr Smita Ghate |
HBT Medical College & Dr. R N Cooper Municipal General Hospital |
Room No : OPD- 17
Division : Ground floor
Department : Dermatology
Mumbai
MAHARASHTRA |
91-9702372980
smita236@rediffmail.com |
| Dr B L Nanjundaswamy |
K. R. Hospital, MMC & RI Mysuru, Karnataka |
Room No: 14-First Floor
Department : Dermatology
(Skin & STD)
Division : OPD Block
Mysore
KARNATAKA |
91-0821-2520512
drblnswami@gmail.com |
| Dr Rachita Dhurat |
LTMMC & LTMGH |
Room No:OPD- Consulting Room
Division: 2nd Floor
Department : Dermatology
Mumbai
MAHARASHTRA |
91- 9870390057
rachitadhurat@yahoo.co.in |
| Dr Arun Vaidya |
Maccare Superspeciality Hospital |
Room No: 01
Division: Clinical Research Department
Department :4th Floor
Ahmadnagar
MAHARASHTRA |
91-2412422411
drarun.vaidya26@gmail.com |
| Dr Ashish Deshmukh |
MGM Medical College & Hospital |
Room No:256
Division:Ground Floor B wing
Department : Dermatology
Aurangabad
MAHARASHTRA |
0240-6482000
drashishdeshmukh01@gmail.com |
| Dr Kingshuk Chatterjee |
Nil Ratan Sircar Medical College and Hospital (NRSMC&H) |
Department: Department of Dermatology
Division: OPD Building
Kolkata
WEST BENGAL |
033-22860033
klose2kingonly@gmail.com |
| Dr Dhwani Makwana |
Parth Hospital |
Room No:E/401, E/405
Division:4th Floor
Department : Dermatology
Ahmadabad
GUJARAT |
91-9662133253
dhwanimakwanacr722@gmail.com |
| Dr Davinder Parsad |
Post Graduate Institute of Medical Education and Research |
Room No:NA
Division: 2nd Floor
Department : Dermatology
Chandigarh
CHANDIGARH |
91-9876060361
parsad@me.com |
| Dr Parag Kalyani |
Prolife Cancer Center & Research Institute |
Room No:OPD- 2
Division: Ground Floor
Department : Dermatology
Pune
MAHARASHTRA |
096070 79019
kalyaniparag@gmail.com |
| Dr Rajesh Dutt Mehta |
S.P. Medical College & AG Hospitals |
Room No: PI OPD Consulting Room
Division: Ground Floor
Department : Dermatology
Bikaner
RAJASTHAN |
0151-2226329
mehtarddr@yahoo.co.in |
| Dr L Eswari |
Victoria Hospital, BMCRI |
Room No:202
Division: 2nd Floor
Department : Dermatology
Bangalore
KARNATAKA |
080 2670 1150
eshwaril@yahoo.com |
|
Details of Ethics Committee
Modification(s)
|
| No of Ethics Committees= 18 |
| Name of Committee |
Approval Status |
| EC Committee S.P. Medical College, Bikaner |
Approved |
| Clinical Research Ethics Committee, School of Tropical Medicine |
Approved |
| CUTIS Instituitional Ethics Committee |
Approved |
| Ethics Cominittee GSVM Medical College |
Approved |
| Ethics Committee of BMCRI |
Approved |
| Ethics Committee,N.R.S. Medical College |
Approved |
| Father Muller Instituitional Ethics Committee |
Approved |
| IEC Dr Mhaske Hospital and Research Centre |
Approved |
| Institutional Ethics Committee |
Approved |
| Institutional Ethics Committee |
Approved |
| Institutional Ethics Committee Maccare Hospital |
Approved |
| Institutional Ethics Committee Mysore Medical College & Research Institute and associated Hospitals |
Approved |
| Institutional Ethics Committee PGIMER |
Approved |
| Institutional Ethics Committee, GMERS Medical College, Sola |
Submittted/Under Review |
| Institutional Ethics Committee, HBTMC and RNCH |
Approved |
| Institutional Ethics Committee- Human Research |
Approved |
| MGM Ethics Committee for Research on Human Subjects |
Approved |
| Parth Hospital Ethics Committee |
Approved |
|
Regulatory Clearance Status from DCGI
Modification(s)
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: L639||Alopecia areata, unspecified, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
SCD-153 (active drug) |
Frequency of Application: once-daily or alternate day or twice-daily
Route of Administration: Topical Application
Duration of Treatment: Approximately 03-06 months
Dose Level: Strength 1, Strength 2, Strength 3 and Strength 4 |
| Comparator Agent |
Vehicle |
Frequency of Application: once-daily or alternate day or twice-daily
Route of Administration: Topical Application
Duration of Treatment: Approximately 03-06 months
Dose Level: Strength 1, Strength 2, Strength 3 and Strength 4 |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
55.00 Year(s) |
| Gender |
Both |
| Details |
1. Adult males between 18-55 years (both inclusive) and adult non-pregnant, non-lactating females between 18-45 years of age (both inclusive) at Screening.
2. Clinical diagnosis of Alopecia Areata.
3. Willingness to provide written informed consent and comply with the protocol requirements.
|
|
| ExclusionCriteria |
| Details |
1. History or presence of clinically relevant, systemic disease.
2. Laboratory abnormalities at Screening that is assessed as clinically significant by the investigator.
3. History of allergy to investigational medicinal product or excipients and any history of and/or concurrent condition of serious hypersensitivity (e.g., anaphylaxis) to drugs, foods, or other allergens.
4. Participation in an investigational drug study in which the administration of the investigational drug was within 30 days.
5. Active inflammatory skin disease other than AA or active trauma on the scalp that could potentially interfere with assessments.
6. History or presence of hair transplants.
|
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Other |
|
Blinding/Masking
|
Participant, Investigator and Outcome Assessor Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Incidence of unacceptable toxicity |
Week 29 |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Incidence and severity of adverse events |
Week 29 |
| Incidence of local skin reactions |
Week 29 |
|
Target Sample Size
Modification(s)
|
Total Sample Size="100"
Sample Size from India="100"
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 1 |
|
Date of First Enrollment (India)
|
18/06/2025 |
| 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
Modification(s)
|
Years="2"
Months="0"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| 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 is a phase 1b, multicenter, randomized, double-blind, vehicle-controlled study to evaluate the safety, tolerability, pharmacokinetics, and efficacy of topically applied SCD-153 in patients with alopecia areata. The subjects will be evaluated in four sequential dose levels (strength 1, strength 2, strength 3 and strength 4) based on the safety data. |