| CTRI Number |
CTRI/2026/01/100212 [Registered on: 02/01/2026] Trial Registered Prospectively |
| Last Modified On: |
12/01/2026 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Other (Specify) [Hair care formulation] |
| Study Design |
Other |
|
Public Title of Study
|
Hair care product study for hair growth improvement and reduction in hair fall. |
|
Scientific Title of Study
|
To evaluate the in vivo efficacy and safety of a hair care formulation
in terms of hair growth i.e. improvement in AT ratio and reduction in hair fall on healthy human subjects |
| Trial Acronym |
Nil |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| XXX-7I02-XK-OR25; Version: 01; Dated: 27/11/2025 |
Protocol Number |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Niharika Salian |
| Designation |
Principal Investigator |
| Affiliation |
MASCOT-SPINCONTROL India Pvt. Ltd. |
| Address |
Sea Breeze Building, 9th Floor, Appasaheb Marathe Marg, Century Bazaar, Prabhadevi, Mumbai, Maharashtra
Mumbai
MAHARASHTRA
400025
India |
| Phone |
02243349191 |
| Fax |
|
| Email |
niharika@mascotspincontrol.in |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Niharika Salian |
| Designation |
Principal Investigator |
| Affiliation |
MASCOT-SPINCONTROL India Pvt. Ltd. |
| Address |
Sea Breeze Building, 9th Floor, Appasaheb Marathe Marg, Century Bazaar, Prabhadevi, Mumbai, Maharashtra
MAHARASHTRA
400025
India |
| Phone |
02243349191 |
| Fax |
|
| Email |
niharika@mascotspincontrol.in |
|
Details of Contact Person
Public Query
|
| Name |
Dr Mohit Lalvani |
| Designation |
Study Director |
| Affiliation |
MASCOT-SPINCONTROL India Pvt. Ltd. |
| Address |
Sea Breeze Building, 9th Floor, Appasaheb Marathe Marg, Century Bazaar, Prabhadevi, Mumbai, Maharashtra
Mumbai
MAHARASHTRA
400025
India |
| Phone |
02243349191 |
| Fax |
|
| Email |
mohit.CTRI@gmail.com |
|
|
Source of Monetary or Material Support
|
| Glenmark Pharmaceuticals Ltd. Corporate Enclave, 2nd Floor, B D Sawant Marg, Chakala, Off western Express Highway, Andheri (East), Mumbai – 400099 |
|
|
Primary Sponsor
|
| Name |
Glenmark Pharmaceuticals Ltd. |
| Address |
Corporate Enclave, 2nd Floor, B D Sawant Marg, Chakala, Off western Express Highway, Andheri (East), Mumbai – 400099 |
| Type of Sponsor |
Pharmaceutical industry-Global |
|
|
Details of Secondary Sponsor
|
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 1 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr Niharika Salian |
Mascot Spincontrol India Pvt. Ltd. |
Sea Breeze Building, 9th Floor, Appasaheb Marathe Marg, Century Bazaar, Prabhadevi, Mumbai, Maharashtra
Mumbai
MAHARASHTRA |
02243349191
niharika@mascotspincontrol.in |
|
Details of Ethics Committee
Modification(s)
|
| No of Ethics Committees= 2 |
| Name of Committee |
Approval Status |
| SRI VENKATESHWARA HOSPITAL ETHICS COMMITTEE |
Approved |
| SRI VENKATESHWARA HOSPITAL ETHICS COMMITTEE |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Healthy Human Volunteers |
showing initial stage of
baldness |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Bontress® PRO+ Scalp Serum (51250129) |
The test product will be applied once daily to a clean and dry scalp and gently massaged for 5 minutes. The intervention will be continued for 84 days. |
| Comparator Agent |
Nil |
NA |
|
|
Inclusion Criteria
|
| Age From |
30.00 Year(s) |
| Age To |
50.00 Year(s) |
| Gender |
Both |
| Details |
1) Indian or Asian male & female subjects.
2)Healthy subjects (no infectious and evolutive pathology which could make the subject
vulnerable and stop the study, no pathology which could interfere with the study, no symptom
in the process of an exploratory checkup)
3)Between 30 and 50 years of age.
4)Skin is healthy on the studied anatomic unit (free of eczema, wounds, inflammatory scar….)
5)Having androgenetic alopecia of class I-2 to I-4 according to Ludwig and Savin Scale for
females and class II to III (including III, IIIA and III vertex) according to Norwood Hamilton
Scale for males. |
|
| ExclusionCriteria |
| Details |
1)For Females: Being pregnant or breastfeeding or having stopped to breastfeed in the past three
months
2)Having refused to give his/her assent by not signing the consent form
Taking part in another study liable to interfere with this study
3)Having a chronic dermatosis liable to modify the cutaneous reactivity on the tested area
4)Being insulin-dependent diabetic or non-insulin-dependent diabetic with a recent therapy (less
than 6 months)
5)Having a progressive asthma (either under treatment or last fit in the last 2 years)
6)Being epileptic
7)Having non stabilized thyroid problems (requirement of a stabilized treatment for at least 6 months)
8)Having cutaneous hypersensitivity
9)Having a diagnosed or highly probable allergy to one or several compounds of the cosmetic
products
10)Following a chronic or intermittent medicinal treatment comprising any of the following
products: aspirin-based products, anti-inflammatories, antihistamines, anti-coagulants,
corticotherapy, taken by general or local routes (the only medication permitted is paracetamol)
11)Having undergone a surgery requiring a general anaesthetic of more than one hour in the past
6 months
12)Having changed his/ her cosmetic habits except those required by the protocol in the 14 days
preceding the start of the study on the studied anatomic unit
13)Having applied a cosmetic product on the studied areas the first day of the study. |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Case Record Numbers |
|
Blinding/Masking
|
Participant and Outcome Assessor Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Safety on skin and hair growth i.e. improvement in AT ratio and reduction in hair fall |
Baseline, Day 28, Day 56 and Day 84 |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Nil |
NA |
|
|
Target Sample Size
|
Total Sample Size="36"
Sample Size from India="36"
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)
|
03/01/2026 |
| 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="5"
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
|
OBJECTIVE: The objective of this study will be to evaluate the in-vivo efficacy and safety of a hair care formulation in terms of hair growth i.e. improvement in AT ratio and reduction in hair fall on healthy human subjects.
The evaluation is performed using: Subject’s Self Evaluation, Dermatological Evaluation: Cosmetic Acceptability, Dermatological Evaluation: Efficacy, Phototrichogram Analysis, Counting of Fallen Hair after Standardized Combing, Analysis of hair thickness through Dino-lite Digital Microscope, Hair pull test, Macro photographs of the Scalp & Hair Shaft.
POPULATION :36 (18 male and 18 female) subjects will be selected for the study. The subjects selected for this study will be healthy males & females aged between 30 and 50 years & showing initial stage of baldness, For Males: Norwood Hamilton Scale Class II to III (including III, IIIA and III vertex); for Females: Ludwig and Savin Scale (I-2 to I-4).
STUDY DURATION: 84 days following the first application of the product. |