| CTRI Number |
CTRI/2025/10/096191 [Registered on: 17/10/2025] Trial Registered Prospectively |
| Last Modified On: |
15/10/2025 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Other (Specify) [Cosmeceuitcal ] |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
Study to check if a hair product helps reduce hair fall and improve hair growth. |
|
Scientific Title of Study
|
A clinical study to evaluate the efficacy and safety of hair care formulation in terms of reduction in hair fall
and improvement in hair growth. |
| Trial Acronym |
Nil |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| XXX-7I01-SN-JY25; Version: 01; Dated: 11/09/2025 |
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
|
| Sun Pharmaceutical Industries Ltd.
Sun House, 201 B/1, Western Express Highway, Goregaon (East), Mumbai, Maharashtra (India) – 400 063 |
|
|
Primary Sponsor
|
| Name |
Sun Pharmaceutical Industries Ltd. |
| Address |
Sun House, 201 B/1, Western Express Highway, Goregaon (East), Mumbai, Maharashtra (India) – 400 063 |
| 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
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Suraksa- Ethics committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Healthy Human Volunteers |
having mild to moderate hair fall |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Anaboom Stem Serum |
The Product is applied on Whole Head including Scalp and Hair shaft three times in a week for the period of 28 days.Along with the test product neutral shampoo is used to wash the hair three times in a week in the treatment phase. |
| Comparator Agent |
Nil |
NA |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
45.00 Year(s) |
| Gender |
Both |
| Details |
1)Asian Indian male and 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 18 and 45 years of age.
4)Skin is healthy on the studied anatomic unit (free of eczema, wounds, inflammatory scar….)
5)Specific criteria: Having mild to moderate hair fall.
|
|
| ExclusionCriteria |
| Details |
1)For female: Being pregnant or breastfeeding or having stopped to breastfeed in the past six months.
2)Having refused to give her assent by not signing the consent form.
3)Taking part in another study is liable to interfere with this study.
4)Having a chronic dermatosis liable to modify the cutaneous reactivity on the tested area.
5)Being insulin-dependent diabetic or non-insulin-dependent diabetic with a recent therapy (less than 6 months)
6)Having a progressive asthma (either under treatment or last fit in the last 2 years)
7)Being epileptic
8)Having non stabilized thyroid problems (requirement of a stabilized treatment for at least 6 months)
9)Having cutaneous hypersensitivity
10)Having a diagnosed or highly probable allergy to one or several compounds of the cosmetic products
11)Following a chronic or intermittent medicinal treatment comprising any of the following products: aspirin-based products, anti-inflammatories, anti-histamines, anti-coagulants, corticotherapy, taken by general or local routes (the only medication permitted is paracetamol)
12)Having undergone a surgery requiring a general anaesthetic of more than one hour in the past 6 months
13)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.
14)Having applied a hair care product and cosmetic product on the studied area as well as on the face the first day of the study (except the neutral shampoo without anti-dandruff and anti hairfall claim)
15)Refusing to follow the below restrictions during the study:
For females: Do not take part in any family planning activities leading to pregnancy and breastfeeding.
Do not take part in another study liable to interfere with this study.
Do not take medicinal treatment comprising any of the following products: aspirin-based products, anti-inflammatories, anti-histamines, anti-coagulants, corticotherapy, taken by general or local routes (the only medication permitted is paracetamol)
Do not change his/her cosmetic habits apart from the particular conditions mentioned in the protocol, on the studied anatomic unit.
During the study: Do not use other hair care products than the tested products to the studied areas (except the neutral shampoo without anti-dandruff and anti hairfall claim.)
The day of the measurements: No hair care must be used including test product. Having untangled their hair at home, before coming to the site for observations, the first day of the study.
16)Specific criteria
Having naturally fair or white hair (Which will interfere the evaluation)
Having a dermatosis on the scalp
Having surgery history on the scalp (micro transplants …)
Refusing the bleaching of two areas of the scalp of approx. 40 hairs, the first day of the study.
Refusing the plucking of approx. 10 hairs, during the entire study
Having presented a factor inducing a telogen effluvium in the 3 months preceding the start of the study (delivery, important stress, high fever…)
In the previous 6 months
Having undergone the Minoxidil treatments
Antiandrogen medicine (cyproterone acetate, spironolactone, flutamide)
Having undergone one of the following treatments known to induce hair loss: retinoids, anti-coagulants, anti-convulsive drugs, chemotherapy, beta-blocking agents, non steroidal anti-inflammatory drugs, corticoids …
Having modified her hormonal contraception
In the previous 3 months
Having undergone a local or general anti hair loss treatment (Biotin, dexpanthenol, sulphur amino-acid, B6 vitamin, zinc)
Having taken a food supplement with an anti hair loss claim
Having taken an iron based treatment.
In the previous 15 days: Having applied a product with an anti hair loss claim (due to breakage) or an anti-dandruff claim
In the two last days preceding the first day of the study: Having applied a shampoo with anti hairfall claim (i.e. having washed their hair)
Refusing to follow the below restrictions during the study:
Do not start, change or stop a hormonal treatment.
Do not start a medicinal treatment which could influence the cycle of the hair (anti-hair loss treatment or treatment inducing hair loss)
Do not use local anti-hair loss treatment nor anti-hair loss cosmetic products.
Do not keep hair length less than 5 cm.
Do not use shampoo or hair care or treatment with an anti-dandruff or anti-hairfall claim.
Do not have hair coloured, lightened or permed at the hairdresser or at home.
Do not use products such as: hair-spray, hair gel, straightening products
Do not perform a traumatic hairstyle which could damage hair.
Do not perform too hot brushing or with a too important frequency.
The day of measurement: Untangle the hair (slightly) at home, before coming to the site for observation
|
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Case Record Numbers |
|
Blinding/Masking
|
Participant and Outcome Assessor Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Reduction in number of fallen hair |
Baseline, Day 28 |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Reduction in the number of fallen hairs, Improvement in hair length, Safety evaluation based on dermatologist assessment, Percentage of subjects reporting improvement in: Reduction of hair fall, Improvement in hair growth, Subject Self-Evaluation questionnaire scores for Safety & Cosmetic appeal. |
Baseline, Day 14, Day 28 |
|
|
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)
|
26/10/2025 |
| 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="0"
Months="4"
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: To assess the
efficacy & safety of hair care formulation, reduction in hair fall and
improvement in hair growth (hair length) in female & male subjects with
mild to moderate hair fall.
Primary Endpoint: Percentage
reduction in number of fallen hair as assessed through counting of fallen hair
after standardized combing at day 28 compared to baseline
Secondary Endpoints: Percentage
reduction in number of fallen hair as assessed through counting of fallen hair
after standardized combing at day 14 compared to baseline
1)Percent improvement in hair length
as assessed by bleaching technique at days 14 & 28 compared to baseline
2) Safety
findings (on clinical examination) by the dermatologist at baseline and days 14
& 28
3) Percent panel agreement*
based on subject self-evaluation (SSE) questionnaire score for efficacy at days
14 & 28 for Reduction in hair fall and Improvement in hair growth
STUDY DESIGN: This is a
comparative (For hair growth, results obtained in treatment phase will be
compared with that of natural growth in conditioning phase), prospective,
interventional study.
STUDY
POPULATION: 36 (18 Male +18 Female) subjects. The subjects selected
for this study are male & female subjects of 18-45 years of age having
mild to moderate hair fall.
STUDY DURATION: Screening
period 1 day, Pretreatment period 28 days, Treatment period 28 days
The evaluation is performed
using:Subject Self Evaluation, Dermatological Evaluation: Cosmetic
Acceptability, Counting of fallen hair after standardized combing,
Measurement of hair growth by bleaching technique
|