| CTRI Number |
CTRI/2024/08/072014 [Registered on: 06/08/2024] Trial Registered Prospectively |
| Last Modified On: |
05/08/2024 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Other (Specify) [Cosmeceuitcal] |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
Effect of Products on dandruff |
|
Scientific Title of Study
|
Evaluation and comparison of in-vivo safety and efficacy of two hair care formulations in terms of Anti-dandruff effect. |
| Trial Acronym |
Nil |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| XXX-XI01-UL-JE24; Version: 01; Dated: 17/07/2024 |
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
|
| Satiya nutraceuticals private limited
Building No B3 2G, Asmeeta textile park Mid. Ind. Kalyan (1), Bhiwandi Road KON, Bhiwandi, Thane, Maharashtra, 421311 |
|
|
Primary Sponsor
|
| Name |
Satiya nutraceuticals private limited |
| Address |
Building No B3 2G, Asmeeta textile park Mid. Ind. Kalyan (1), Bhiwandi Road KON, Bhiwandi, Thane, Maharashtra, 421311 |
| 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 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 |
| Patients |
(1) ICD-10 Condition: L219||Seborrheic dermatitis, unspecified, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Non-Conditioning Shampoo |
Product is applied on scalp and shafts, thrice a week for period of 28 days. |
| Intervention |
Test Regime |
This is a regime with 4 products in it. will be applied on the scalp and shafts. Neem Antidandruff
advance antifungal
Treatment, twice a week for period of 28 days.Neem Antidandruff
Shampoo and Neem Antidandruff
conditioner thrice a week for period of 28 days and Neem Antidandruff
Advance hair
serum daily once in night for the period of 28 days. |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
35.00 Year(s) |
| Gender |
Both |
| Details |
1.Asian Indian male/female subjects.
2.Healthy subjects
3.Skin is healthy on the studied anatomic unit (free of eczema, wounds, inflammatory scar.)
4.Having moderate to severe dandruff.
|
|
| ExclusionCriteria |
| Details |
1. for female, Being pregnant or breastfeeding or having stopped to breastfeed in the past three months
2. Having refused to give her/his assent by not signing the consent form
3. Taking part in another study liable to interfere with this study
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. Having a chronic dermatosis liable to modify the cutaneous reactivity on the tested area (except for specific studies on a determined dermatosis)
7. Having non stabilized thyroid problems (requirement of a stabilized treatment for at least 6 months)
8. Being epileptic.
9. Following a chronic medicinal treatment comprising any of the following products: aspirin-based products, anti-inflammatories, anti-histamines, corticotherapy, taken by general or local routes (the only medication permitted is paracetamol)
10. Having cutaneous hypersensitivity.
11. Having a diagnosed or highly probable allergy to one or several compounds of the cosmetic products.
12. Having undergone a surgery requiring a general anesthetic of more than one hour in the past 6
months. |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Case Record Numbers |
|
Blinding/Masking
|
Participant Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| anti-dandruff effect |
Baseline, 2 days, 72 hours, Day 14, Day28 |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| moisturization & sebum reduction |
Baseline, 2 days, 72 hours, Day 14, Day28 |
|
|
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)
|
16/08/2024 |
| 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="2"
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 &
compare the in-vivo safety and efficacy of two hair care formulation in terms
of anti-dandruff effect on healthy human subjects:
Secondary Objective
The secondary objective of the study will be to
evaluate the safety and efficacy of two hair care formulation in terms of
moisturization & sebum reduction on healthy human subjects
The evaluation will be performed using: Subject’s Self
Evaluation, Dermatological Evaluation: Cosmetic Acceptability, Dermatological
Evaluation: Efficacy, Corneometry, Sebumetry, Photographs of scalp build-up by
Denolite
The study will last for 35 days including the 7 days
conditioning phase and 28 days application period.
POPULATION: 72 (36 male & 36 female) subjects will
be selected for the study. The subjects selected for this study will be healthy
male / female aged between 18 and 35 years, having moderate to severe dandruff.
36 subject for Test regime & 36 Subjects for
comparative product) subjects
The study will be conducted in 2 groups.
Group A: This group will include 36 (18 male & 18
female) subjects using Regime (Product A to
Product D).
Group B: This group will include 36 (18 male & 18
female) subjects using comparative product E. |