| CTRI Number |
CTRI/2024/10/075870 [Registered on: 25/10/2024] Trial Registered Prospectively |
| Last Modified On: |
24/10/2024 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Other (Specify) [Cosmeceuitcal] |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
Evaluating the Safety and Effectiveness of a Hair Care Product for Reducing Grey Hair in Healthy People |
|
Scientific Title of Study
|
The objective of this study will be to evaluate the invivo safety and efficacy of a hair care formulation in terms of reduction in grey hair on healthy human subject |
| Trial Acronym |
Nil |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| XXX-7I01-7C-AT24; Version: 01; Dated: 18/09/2024 |
Protocol Number |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Pooja Yadav |
| 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 |
poojayadav@mascotspincontrol.in |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Pooja Yadav |
| 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 |
poojayadav@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
|
| Curetech Skincare
Plot No. 32, 33 & 34 Phase-IV
Bhatoli Kalan Baddi Dist. Solan H.P,
PIN – 173205 |
|
|
Primary Sponsor
|
| Name |
Curetech Skincare |
| Address |
Plot No. 32, 33 & 34 Phase-IV Bhatoli Kalan Baddi Dist. Solan H.P, PIN – 173205 |
| Type of Sponsor |
Pharmaceutical industry-Indian |
|
|
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 Pooja Yadav |
MASCOT-SPINCONTROL India Pvt. Ltd. |
Sea Breeze Building, 9th Floor, Appasaheb Marathe Marg, Century Bazaar, Prabhadevi, Mumbai, Maharashtra
Mumbai
MAHARASHTRA |
02243349191
poojayadav@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 mild to moderate greying of hair |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Dermina greygone - antigreying hair serum |
Product to be applied on whole scalp and shafts, two times in a day for the period of 84 days. |
| Comparator Agent |
Nil |
NA |
|
|
Inclusion Criteria
|
| Age From |
20.00 Year(s) |
| Age To |
45.00 Year(s) |
| Gender |
Both |
| Details |
1) Indian / Asian male & female subjects.
2) Healthy subjects
3) Skin is healthy on the studied anatomic unit
4) Subjects with non-congenital factors contributing to premature graying, such as stress, dietary habits, or environmental exposure & those with congenital factors may also be included,
5) Having a mild to moderate greying severity score in a one-to-one ratio.
|
|
| 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
3. Taking part in another study 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, antihistamines, 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 |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Case Record Numbers |
|
Blinding/Masking
|
Participant Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Reduction in grey hair |
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)
|
04/11/2024 |
| 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
|
OBJECTIVE: The objective of this study will be to
evaluate the in-vivo safety and efficacy of a hair care formulation in terms of
reduction in grey hair on healthy human subjects
The evaluation will be performed using:Subject’s self
assessment questionnaire, Dermatological evaluation: Cosmetic Acceptability, Dermatological
evaluation: Efficacy, Phototrichogram Analysis
The study lasts 84 days following the first
application of the product.
POPULATION: 36 (18 female & 18 male) subjects will
be selected for the study.
The subjects selected for this study are healthy males
& females, aged between 20 and 45 years old, segmented into three age
groups (Group 1: 20-29 years, Group 2: 30-37 years & Group 3: 38-45 years),
having mild to moderate (on scale of 0- 10) greying severity score.
STUDY DURATION: 84 days following the first
application of the product.
STUDY DESIGN: Single blind study. Non-Comparative
study. Subjects will serve as their own references |