| CTRI Number |
CTRI/2023/07/055158 [Registered on: 13/07/2023] Trial Registered Prospectively |
| Last Modified On: |
02/08/2023 |
| Post Graduate Thesis |
No |
| Type of Trial |
Observational |
|
Type of Study
|
Cross Sectional Study |
| Study Design |
Other |
|
Public Title of Study
|
An observational study to assess clinical impact of hair serum in Indian Patients with patterned hair loss |
|
Scientific Title of Study
|
An Investigator Initiated Observational study to assess the Safety & Clinical impact of Curcumin longa based Hair Serum in Indian Patients with AGA & FPHL (SCALP Study) |
| Trial Acronym |
NA |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| IIS2303452 Version-01 24Jun23 |
Protocol Number |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Rachita Dhurat |
| Designation |
Principal Investigator |
| Affiliation |
RD Clinic |
| Address |
RD Clinic, Department of Dermatology, Skin No 16, 2nd Floor, new building, LTMG Hospital, Sion, Mumbai, Maharashtra- 400022, India
Mumbai
MAHARASHTRA
Mumbai
MAHARASHTRA
400071
India |
| Phone |
9833394951 |
| Fax |
|
| Email |
rachitadhurat88@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Krishnaprasad K MD |
| Designation |
General Manager - Medical Services |
| Affiliation |
Torrent Pharmaceuticals Ltd |
| Address |
Torrent Pharmaceuticals Ltd
Ashram Road - Navrangpura Ahmedabad GUJARAT 380009 India
Ahmadabad
GUJARAT
380009
India |
| Phone |
7069000572 |
| Fax |
|
| Email |
krishnaprasadkorukonda@torrentpharma.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Rathish Nair PhD MBA |
| Designation |
Manager - Medical Services |
| Affiliation |
Torrent Pharmaceuticals Ltd |
| Address |
Torrent Pharmaceuticals Ltd
Ashram Road - Navrangpura Ahmedabad GUJARAT 380009 India
Ahmadabad
GUJARAT
380009
India |
| Phone |
7069000560 |
| Fax |
|
| Email |
RathishNair@TorrentPharma.com |
|
|
Source of Monetary or Material Support
|
| RD Clinic, Department of Dermatology, Skin No 16, 2nd Floor, new building, LTMG Hospital, Sion, Mumbai, Maharashtra- 400022, India Mumbai MAHARASHTRA |
|
|
Primary Sponsor
|
| Name |
Not applicable |
| Address |
Not applicable |
| Type of Sponsor |
Other [Not applicable] |
|
|
Details of Secondary Sponsor
|
| Name |
Address |
| NIL |
Not Applicable |
|
|
Countries of Recruitment
|
India |
Sites of Study
Modification(s)
|
| No of Sites = 9 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr Pradeep Kumari |
Asia Institute of Hair Transplant |
2nd Floor, Above Maruti Showroom, Near Phoenix Mal, Nagar Road, Viman Nagar, Pune, Maharashtra-411014, India
Department - Dermatology
Division - Clinical Research
Room - Not available
Pune
MAHARASHTRA |
9623050666
Drpkumari263@gmail.com |
| Dr Gaurav Garg |
DERMALIFE REDEFINE YOURSELF |
DERMALIFE REDEFINE YOURSELF, G-29, GREEN PARK MAIN ROAD,NEW DELHI,NEW DELHI-110016
Department - Dermatology
Division - Clinical Research
Room - Area defined for Research
South West
DELHI |
9953965010
Drgauravgarg20@gmail.com |
| Dr Anil Ganjoo |
Dr Ganjoos Skin & Cosmetology Centre |
Dr. Ganjoos Skin & Cosmetology Centre, 105/4 LSC, GujranwalaTown, Delhi -110009
Department - Dermatology
Division - Clinical Research
Room - Area defined for Research
North West
DELHI |
9811066584
Anilganjoo51@gmail.com |
| Dr Manjul Agarwal |
Dr Manjul Agrwals Clinic |
BP-53, Opp. MUNI MAYA RAM HOSPITAL, MAURYA ENCLAVE, BLOCK BP, POORVI PITAMPURA, PITAMPURA, NEW DELHI-110034
Department - Dermatology
Division - Clinical Research
Room#53
North West
DELHI |
9811282516
Drmanjulag1@gmail.com |
| Dr Shreyas Kamath |
Dr Shreyas Kamath - Clinic |
1st Floor, Jacob Apartments,
Opposite Smaridhi Society, Near Navneet Publications, Off Bhavani Shankar Road, Dadar (West), Mumbai - 400028, Maharashtra, India
Mumbai
MAHARASHTRA |
9820398134
drshreyaskamath@gmail.com |
| Dr Pradyuman Vaidya |
Dr Vaidyas Skin & Laser Clinic |
Bendre Niwas, 1330, Sadashiv Peth,
Near Bharat Natya Mandir, Pune, Maharashtra - 411030, India
Department - Dermatology
Division - Clinical Research
Room - Not available
Pune
MAHARASHTRA |
9822400964
Drpvaidya1234@gmail.com |
| Dr Sumit Gupta |
GNH Excel Medical Centre |
GNH Excel Medical Centre, BN-56 (East) Shalimar Bagh, Delhi 110088
Department - Dermatology
Division - Clinical Research
Room - Area defined for Research
North West
DELHI |
9811341350
Drsumitg1@gmail.com |
| Dr Rachita Dhurat |
RD Clinic |
RD Clinic, Department of Dermatology, Skin OPD No 16, 2nd Floor, new building, LTMG Hospital, Sion, Mumbai, Maharashtra- 400022, India
Mumbai
MAHARASHTRA |
9833394951
rachitadhurat88@gmail.com |
| Dr Shankar Savant |
Rejoice Aesthetic Experts |
214, L J Road, Raja Rani Building, 1st Floor, Mahim (W), Mumbai, Maharastra - 400016, India
Department - Dermatology
Devision - Clinical Studies
Room Number - 214
Mumbai
MAHARASHTRA |
9821535513
drssawant1234@gmail.com |
|
Details of Ethics Committee
Modification(s)
|
| No of Ethics Committees= 9 |
| Name of Committee |
Approval Status |
| Ethicare Ethics Committee |
Approved |
| Ethicare Ethics Committee |
Approved |
| Ethicare Ethics Committee |
Approved |
| Park Hospital Ethics Committee |
Approved |
| Park Hospital Ethics Committee |
Approved |
| Park Hospital Ethics Committee |
Approved |
| Park Hospital Ethics Committee |
Approved |
| Royal Pune Independent Ethics Committee |
Approved |
| Royal Pune Independent Ethics Committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: L649||Androgenic alopecia, unspecified, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Cuticapil Stem Hair Serum |
2% Minoxidil Monotherapy or with 2% Minoxidil therapy and Cuticapil Stem (Purmed water, caffeine, herbasome, Zemea propandiol, procapil, DC 193 C, Capilia Longa, Euxyl PE 9010, Cressatine, Ronacare Biotin plus sodium gluconate) as an add on to minoxidil therapy
Route of Administration- Topical on scalp
Dosage form - Liquid suspension
Dose - 1 ml of Cuticapil and spread the liquid evenly over the hair loss area. Rub with fingers gently and apply twice a daily for 12 weeks
|
| Comparator Agent |
NIL |
NIL |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
99.00 Year(s) |
| Gender |
Both |
| Details |
Male or female patients of 18 or above with diagnosis of hair loss
Hair shedding > 6 month
Clinical diagnosis of male AGA Grade III, Grade IV, Grade V and clinical diagnosis of FPHL Grade II and Grade III naïve cases or treated with 5% Minoxidil.
Patients with no known allergy.
Patients who agree to refrain from using hair dye, oil treatment or spa treatment, perming or straightening during the treatment/observation period
Patients who agree to use Non ketoconazole based shampoo |
|
| ExclusionCriteria |
| Details |
Cosmetic hair treatments 1 month prior to enrolment
Patients with Hemoglobin level below 10.5
Patients with thyroid disorders or other systemic disorders including T2DM, Hypertension, HIV, Hepatitis, Anemia, Heart disorders, Cancer & undergone chemotherapy, Depression, any psychiatric disorders and those taking drugs which could cause alopecia
Pregnant and lactating females
Patients with scalp disease
Heavy Smokers & heavy drinkers
Patients on crash diets |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
Change in hair count shedding after shampooing from baseline at 10 weeks.
Change in hair count with Pull test from baseline at 10 weeks.
Global photography assessment at 10 week as centrally adjudicated scale score
for hair count. |
at 10 week |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
Safety assessment of the hair serum
AGA, FPHL, Patient Global Assessment
|
At 10 week |
|
|
Target Sample Size
|
Total Sample Size="120"
Sample Size from India="120"
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)
|
24/07/2023 |
| 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="0"
Months="4"
Days="0" |
Recruitment Status of Trial (Global)
Modification(s)
|
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
Modification(s)
|
This is a Multicenter, Case-cohort, Observational study planned to assess Safety & Clinical impact of Curcumin longa based Hair Serum in Indian Patients with hair loss.
Cuticapil serum is a combination of biotinyl GHK with apigenin a flavonoid from citrus and oleanolic acid from olive tree leaves. Also liposome based Caffeine and Cressantine works on unique mechanism to improve hair growth. It is also enriched with Biotin Plus.
The rationale of this study is to assess real world clinical safety and efficacy of Cuticapil Stem hair serum in patterned hair loss in men & women in India.
As the study will be conducted in the real life setting, study medication will be prescribed by the investigator and the patients will purchase the drug from the pharmacy. |