| CTRI Number |
CTRI/2024/04/065569 [Registered on: 12/04/2024] Trial Registered Prospectively |
| Last Modified On: |
10/04/2024 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Other (Specify) [Cosmaceutical] |
| Study Design |
Other |
|
Public Title of Study
|
Checking of safety and efficacy of product |
|
Scientific Title of Study
|
Evaluation of in vivo safety and efficacy of hair care formulation in terms of hair growth effect. |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| XXX-7I01-KZ-MH24; Version: 01; Dated:22/03/2024 |
Protocol Number |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Raji Patil |
| Designation |
Principal Investigator |
| Affiliation |
MASCOT-SPINCONTROL India Pvt. Ltd. |
| Address |
Mascot Spincontrol India Pvt. Ltd. Kohinoor Estate, 3rd Floor Sun Mill Compound, Lower Parel
Mumbai
MAHARASHTRA
400013
India |
| Phone |
02243349191 |
| Fax |
|
| Email |
raji@mascotspincontrol.in |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Raji Patil |
| Designation |
Principal Investigator |
| Affiliation |
MASCOT-SPINCONTROL India Pvt. Ltd. |
| Address |
Mascot Spincontrol India Pvt. Ltd. Kohinoor Estate, 3rd Floor Sun Mill Compound, Lower Parel
MAHARASHTRA
400013
India |
| Phone |
02243349191 |
| Fax |
|
| Email |
raji@mascotspincontrol.in |
|
Details of Contact Person
Public Query
|
| Name |
Dr Mohit Lalvani |
| Designation |
Study Director |
| Affiliation |
MASCOT-SPINCONTROL India Pvt. Ltd. |
| Address |
Mascot Spincontrol India Pvt. Ltd. Kohinoor Estate, 3rd Floor Sun Mill Compound, Lower Parel
Mumbai
MAHARASHTRA
400013
India |
| Phone |
02243349191 |
| Fax |
|
| Email |
mohit.CTRI@gmail.com |
|
|
Source of Monetary or Material Support
|
| KAYA LIMITED
23/C, Mahal Industrial Estate, Mahakali Caves Road,
Near Paper Box Lane,
Andheri (East), Mumbai - 400093. |
|
|
Primary Sponsor
|
| Name |
KAYA LIMITED |
| Address |
KAYA LIMITED
23/C, Mahal Industrial Estate, Mahakali Caves Road,
Near Paper Box Lane,
Andheri (East), Mumbai - 400093. |
| Type of Sponsor |
Other [FMCG] |
|
|
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 Raji Patil |
Mascot Spincontrol India Pvt. Ltd. |
Mascot Spincontrol India Pvt. Ltd. Kohinoor Estate, 3rd Floor Sun Mill Compound, Lower Parel
Mumbai
MAHARASHTRA |
02243349191
raji@mascotspincontrol.in |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Ethos- An Institutional Ethics committee (Mumbai) |
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 |
Kaya Regenerist
Serum |
The product is applied on Whole Head(Including Scalp and Hair shaft), for a period of 84 days. |
| Comparator Agent |
NIL |
NA |
|
|
Inclusion Criteria
|
| Age From |
30.00 Year(s) |
| Age To |
50.00 Year(s) |
| Gender |
Both |
| Details |
Indian / Asian male & female subjects.
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)
Between 30 and 50 years of age.
Skin is healthy on the studied anatomic unit (free of eczema, wounds, inflammatory scar….)
Having androgenetic alopecia of class I-2 to I-4 according to Ludwig Scale for females and
class II to III (including III, IIIA and IIIvertex) according to Norwood Hamilton Scale for males. |
|
| ExclusionCriteria |
| Details |
For Females: Being pregnant or breastfeeding or having stopped to breastfeed in the past three
months
Having refused to give his/her assent by not signing the consent form
Taking part in another study liable to interfere with this study
Having a chronic dermatosis liable to modify the cutaneous reactivity on the tested area
Being insulin-dependent diabetic or non insulin-dependent diabetic with a recent therapy (less
than 6 months)
Having a progressive asthma (either under treatment or last fit in the last 2 years)
Being epileptic
Having non stabilized thyroid problems (requirement of a stabilized treatment for at least 6
months)
Having cutaneous hypersensitivity
Having a diagnosed or highly probable allergy to one or several compounds of the cosmetic products
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)
Having undergone a surgery requiring a general anaesthetic of more than one hour in the past 6 months
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
Having applied a cosmetic product on the studied areas the first day of the study.
Refusing to follow the restrictions below during the study:
- For female, 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, antihistamines, anti-coagulants, corticotherapy, taken by general or local routes (the only medication permitted is paracetamol).
- Do not change his 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 (Only provided test product is allowed).
- The day of the measurements: Hair must be washed with provided neutral shampoo. No other hair care product must be used.
Having naturally fair or white hair
Having a dermatosis on the scalp
Having history of any hormonal problem.
Having surgery history on the scalp (micro transplants …)
Refusing the shaving of an area of the scalp of about 1.5 cm², the first day of the study and several times during the study
Having presented a factor inducing a telogen effluvium in the 3 months preceding the start of the study (important stress, high fever…)
Presenting an acute or chronic general disease or pathology which could have an influence on hair endocrinopathy (diabetes, thyroid…), high blood pressure, renal problems, hepatic problems, known anemia.
Having contact allergy or atopic predisposition.
Having history of medical/surgical events that may significantly affect the study outcome e.g.,h/o typhoid or jaundice etc. |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Case Record Numbers |
|
Blinding/Masking
|
Participant Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Hair growth i.e., improvement in A:T ratio & safety |
Screening, Baseline,T+14 Days, T+26 Days,T+28 Days,T+42 Days, T+54 Days,T+56 Days,T+70 Days,T+82 Days,T+84 Days |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
Improvement
in hair thickness, reduction in hair fall |
Baseline, 28 day, 56 day, 84 day |
|
|
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)
|
21/04/2024 |
| 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
|
Primary Objective:
The objective of this study will
be to evaluate in vivo safety and efficacy of hair care formulation in terms
of hair growth i.e., improvement
in A:T ratio on healthy human subjects for product coded:
Secondary Objective:
The objective of this study is to
evaluate the efficacy of Skin care formulation in terms of improvement
in hair thickness, reduction in
hair fall on healthy human subjects.
Population: 36 (18 male and 18
female) subjects are selected for the study
The subjects selected for this
study are
healthy males & females aged
between 30 and 50 years & showing initial stage of baldness, For
Males: Hamilton Scale Class II to
III (including III, IIIA and III vertex) ; for Females: Ludwig
Study timepoints: Screening, Baseline,
T+14 Days, T+26 Days, T+28 Days, T+42 Days, T+54 Days, T+56
Days, T+70 Days, T+82 Days, T+84
Days
The evaluation is performed using:
Subject’s self-assessment questionnaire, Dermatological evaluation: Cosmetic
Acceptability, Phototrichogram analysis, Analysis of hair thickness through
Dino-lite Digital Microscope, Counting of Fallen Hair after Standardized
Combing |