| CTRI Number |
CTRI/2025/02/080041 [Registered on: 07/02/2025] Trial Registered Prospectively |
| Last Modified On: |
17/04/2025 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Other (Specify) [Cosmeceuitcal] |
| Study Design |
Randomized, Parallel Group, Active Controlled Trial |
|
Public Title of Study
|
Evaluation Anti dandruff effect of the test products |
|
Scientific Title of Study
|
A clinical study to evaluate the Anti dandruff efficacy of test products |
| Trial Acronym |
Nil |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| XXX-XI03-UV-JR25; Version: 01; Dated: 22/01/2025 |
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
|
| Hindustan Unilever Limited,
Unilever House, B.D. Sawant Marg, Chakala,
Mumbai- 400 099
|
|
|
Primary Sponsor
|
| Name |
Hindustan Unilever Limited |
| Address |
Unilever House, B.D. Sawant Marg, Chakala,
Mumbai- 400 099
|
| 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
Modification(s)
|
| No of Ethics Committees= 2 |
| Name of Committee |
Approval Status |
| Suraksa- Ethics committee |
Approved |
| Suraksa- Ethics committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Healthy Human Volunteers |
Healthy subjects with Dandruff(L21.9, Seborrheic Dermatitis, unspecified) |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Scalp product 1 |
The product is applied on whole scalp three times in a week for the period of 28 days. |
| Comparator Agent |
Scalp Product 2 |
The product is applied on whole scalp three times in a week for the period of 28 days. |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
45.00 Year(s) |
| Gender |
Both |
| Details |
1)Healthy male & female volunteers between 18-45 years of age.
2)Volunteer presenting with dandruff as per dermat assessment
3)Volunteer in good health condition as per the medical screening criteria with no disease state or physical condition that the Investigator believes could interfere with the interpretation of the data.
4)Volunteer able to read, understand and sign an appropriate informed consent form indicating her willingness to participate.
5)Volunteers agreeing to comply with following study restrictions:
- Volunteers Willing to refrain from application of any other product/treatment on their scalp and hair shafts during the study period.
- Not applying any cosmetic, hair care product, test product and/or water 48 hours before scheduled visits.
|
|
| ExclusionCriteria |
| Details |
1)Volunteers who participated in a study with scalp/ hair shaft as the target area within 4 weeks of the start of this study or is currently participating in such a study.
2)Volunteer pregnant or planning to become pregnant.
3)Volunteers who are breastfeeding or having stopped to breastfeed in the past three months.
4)Volunteers with any other signs of significant local irritation, erythema or skin disease on scalp as well as on the visible parts of the body skin site.
5)Volunteers with self-perceived sensitive skin.
6)Volunteers having chronic illness or had major surgery in the last year.
7)Volunteers undergoing any treatment of any skin condition on body.
|
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Case Record Numbers |
|
Blinding/Masking
|
Participant and Investigator Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Significant reduction in dandruff flakes |
Baseline, 1 week, 2 week, 3 weeks, 4 week and 5 weeks |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Reduction in scalp itch |
Baseline, 1 week, 2 week, 3 weeks, 4 week and 5 weeks |
|
|
Target Sample Size
|
Total Sample Size="100"
Sample Size from India="100"
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
|
Phase 2 |
|
Date of First Enrollment (India)
|
17/02/2025 |
| 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
|
This clinical trial is being conducted to ascertain the efficacy and safety of test product on healthy human Indian volunteers suffering from dandruff. Volunteers will be enrolled basis on inclusion criteria mentioned in the protocol. Product usage instruction will be provided to volunteers at the initiation of the study. Safety and efficacy assessment will be done by the dermatologist and ayurvedic doctors at regular period on weekly basis. Assessment will be compared change form baseline value. |