| CTRI Number |
CTRI/2023/07/055079 [Registered on: 11/07/2023] Trial Registered Prospectively |
| Last Modified On: |
10/07/2023 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Other (Specify) [Efficacy] |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
Safety and efficacy assessment of hair care Product on skin |
|
Scientific Title of Study
|
To evaluate & compare the in-vivo safety and efficacy of a Hair Care Regime Versus a Hair Care Formulation in terms of hair growth(hair length), reduction in hair fall and reduction in dandruff on healthy female subjects |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| XXX-7I01-IT-JE23; Version: Final 01; 28/06/2023 |
Protocol Number |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Raji Patil |
| Designation |
Investigator |
| Affiliation |
MASCOT-SPINCONTROL India Pvt. Ltd. |
| Address |
Kohinoor Estate, 3rd Floor, Sun Mill Compound, Lower Parel West, Mumbai.
Mumbai
MAHARASHTRA
400013
India |
| Phone |
02243349191 |
| Fax |
|
| Email |
raji@mascotspincontrol.in |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Raji Patil |
| Designation |
Investigator |
| Affiliation |
MASCOT-SPINCONTROL India Pvt. Ltd. |
| Address |
Kohinoor Estate, 3rd Floor, Sun Mill Compound, Lower Parel West, Mumbai.
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 |
Kohinoor Estate, 3rd Floor, Sun Mill Compound, Lower Parel West, Mumbai.
Mumbai
MAHARASHTRA
400013
India |
| Phone |
02243349191 |
| Fax |
|
| Email |
mohit.CTRI@gmail.com |
|
|
Source of Monetary or Material Support
|
| Incnut Lifestyle Retail Pvt. Ltd.
G3, Ground floor, Modren profound Tech Park,
Kondapur, Serilingampally, Ranga Reddy District,
Hyderabad-500084 |
|
|
Primary Sponsor
|
| Name |
Incnut Lifestyle Retail Pvt Ltd |
| Address |
G3, Ground floor, Modren profound Tech Park,
Kondapur, Serilingampally, Ranga Reddy District,
Hyderabad-500084 |
| Type of Sponsor |
Other [FMCG] |
|
|
Details of Secondary Sponsor
|
| Name |
Address |
| NIL |
Not applicable |
|
|
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. |
Kohinoor Estate, 3rd Floor, Sun Mill Compound, Lower Parel West, Mumbai.
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 |
having
moderate to severe hair fall, moderate to severe dandruff and having dry scalp & wavy hair |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Regime with Vapra Hair Oil, Root Strengthening hair pack, vardara shampoo, Vartha hydrating no frizz Hair Conditioner, Nuyantra serum |
Group of 36 subjects will use all the products except Nuyantra serum twieina week and Nuyantra serum will be used thrice inweek for the period of 28 days on their scalp and shafts |
| Comparator Agent |
Vapra Hair Oil |
Another group of 36 subject will use Vapra Hair Oil, twice in a week on their scalp and shafts for the period of 28 days |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
45.00 Year(s) |
| Gender |
Female |
| Details |
1) Indian / Asian 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 & scalp is healthy on the studied anatomic unit (free of eczema, wounds, inflammatory scar….)
5) Having moderate to severe hair fall.
6) Having moderate to severe dandruff.
7) Having Dry scalp and Wavy hair.
8) Subjects must complete a Questionnaire inputing the scalp type and hair type mentioned. https://vedix.com/pages/vpq
|
|
| ExclusionCriteria |
| Details |
1)Being insulin-dependent diabetic or non insulin-dependent diabetic with a recent therapy (less than 6 months)
2) Having a progressive asthma (either under treatment or last fit in the last 2 years)
3) Being epileptic
4) Having non stabilized thyroid problems (requirement of a stabilized treatment for at least 6 months)
5) Having cutaneous hypersensitivity
6) Having a diagnosed or highly probable allergy to one or several compounds of the cosmetic products
7) 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)
8) Having undergone a surgery requiring a general anaesthetic of more than one hour in the past 6 months
9) 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.
10) 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 hairfall claim or hair growth claim)
11) Refusing to follow the restrictions below during the study: - 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 hairfall claim or hair growth 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.
12)Having naturally fair or white hair (Which will interfere the evaluation)
13) Having a dermatosis on the scalp
14) Having surgery history on the scalp (micro transplants …)
15) Refusing the bleaching of two areas of the scalp of approx. 40 hairs, the first day of the study.
16) Refusing the pluking of approx. 10 hairs, during the entire study
17) Having presented a factor inducing a telogen effluvium in the 3 months preceding the start of the study (delivery, important stress, high fever…)
18) 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
19) In the previous 3 months • Having undergone a local or general anti hair loss treatment (Biotine, dexpanthenol, sulphur amino-acid, B6 vitamin, zinc …) • Having taken a food supplement with an anti hair loss claim • Having taken an iron based treatment.
20) In the previous 30 days • Having applied a product with an anti hair loss claim (due to breakage).
21) 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)
22) Refusing to follow the restrictions below 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 anti-hairfall claim or hair growth 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 nor perform too hot brushing or with a too important frequency. - The day of measurenent: Untangle the hair (slightly) at home, before coming to the site for observation.
|
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Participant Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
Hair growth (hair length), reduction in hair
fall & reduction in dandruff |
Baseline, 14 days, 28 days |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| No |
Not applicable |
|
|
Target Sample Size
|
Total Sample Size="72"
Sample Size from India="72"
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)
|
20/07/2023 |
| 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)
|
Not Yet Recruiting |
| 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 &
compare the in-vivo safety and efficacy of a Hair Care Regime Versus a Hair
Care Formulation in terms of hair growth (hair length), reduction in hair fall
and reduction in dandruff on healthy female subjects
POPULATION - 72 Female subjects will be selected for the study.
The subjects selected for this study are healthy females, aged between 18 and
45 years old having moderate to severe hair fall, moderate to severe dandruff
and having dry scalp & wavy hair. The study will be conducted in 2 groups.
I. Group A: This group will include 36 female subjects who will be using the
Test Regime (Product A to Product E). II. Group B: This group will include 36
female subjects who will be using Product F.
DURATION - 56 days including the 28 days of conditioning
phase and 28 days of treatment phase
STUDY DESIGN - Single blind study.
Comparative study.
(For hair growth results obtained in treatment phase will be compared with that
of natural growth in conditioning phase)
Subjects served as their own reference for the intra-group
comparison (evaluation of the efficacy on time of each product) and for the
inter-group comparison (comparison of the efficacy of the test regime &
with test product)
The evaluation is performed using-
Subject’s Self Evaluation ▪ Dermatological Evaluation:
Safety â–ª Dermatological Evaluation: Efficacy â–ª Measurement of Hair Growth by
Bleaching Technique â–ª Counting of Fallen Hair after Standardized Combing â–ª
Photographs of scalp build-up by Trichoscope |