| CTRI Number |
CTRI/2025/08/092970 [Registered on: 13/08/2025] Trial Registered Prospectively |
| Last Modified On: |
|
| Post Graduate Thesis |
No |
| Type of Trial |
PMS |
|
Type of Study
|
Other (Specify) [Cosmetics] |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
Anti-Dandruff activity of a regime of Man Matters Advance Daily Use Anti-Dandruff Shampoo |
|
Scientific Title of Study
|
A Clinical Study to Evaluate the Anti-Dandruff activity of a regime of Man Matters Advance Daily Use Anti-Dandruff Shampoo |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| CCFT776 Version 1.0 dated 01 Aug 2025 |
Protocol Number |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Robin Chugh |
| Designation |
Principal Investigator |
| Affiliation |
CCFT Laboratories |
| Address |
CCFT Laboratories, Mittal Group Building, 121-B Mansarovar Industrial Estate, Panchli, Baghpat Road
Meerut
UTTAR PRADESH
250005
India |
| Phone |
09027285265 |
| Fax |
|
| Email |
robinderm25@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Puneet Mittal |
| Designation |
Clinical Research Consultant |
| Affiliation |
CCFT Laboratories |
| Address |
CCFT Laboratories, Mittal Group Building, 121-B Mansarovar Industrial Estate, Panchli, Baghpat Road
Meerut
UTTAR PRADESH
250005
India |
| Phone |
08937015757 |
| Fax |
|
| Email |
puneetmittal@mgcts.org |
|
Details of Contact Person
Public Query
|
| Name |
Puneet Mittal |
| Designation |
Clinical Research Consultant |
| Affiliation |
CCFT Laboratories |
| Address |
CCFT Laboratories, Mittal Group Building, 121-B Mansarovar Industrial Estate, Panchli, Baghpat Road
UTTAR PRADESH
250005
India |
| Phone |
08937015757 |
| Fax |
|
| Email |
puneetmittal@mgcts.org |
|
|
Source of Monetary or Material Support
|
| CCFT Laboratories, Mittal Group Building, 121-B Mansarovar Industrial Estate, Panchli, Baghpat Road, Meerut, UTTAR PRADESH-250005 |
| Mosaic Wellness Pvt. Ltd, 6th Floor, ThaneOne West - 400610 |
|
|
Primary Sponsor
|
| Name |
Mosaic Wellness Pvt. Ltd |
| Address |
6th Floor, ThaneOne West - 400610 |
| Type of Sponsor |
Pharmaceutical industry-Indian |
|
|
Details of Secondary Sponsor
|
| Name |
Address |
| Not Applicable |
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 Robin Chugh |
CCFT laboratories |
CCFT Laboratories, Mittal Group Building, 121-B Mansarovar Industrial Estate, Panchli, Baghpat Road
Meerut
UTTAR PRADESH |
09027285265
robinderm25@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| ARMHRC Institutional Ethics Committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Healthy Human Volunteers |
Not Applicable |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Not Applicable |
Not Applicable |
| Intervention |
Test Product: Man Matters Advance Daily Use Anti-Dandruff Shampoo |
Gently apply the Shampoo over the Scalp. Route of Administration: Topical duration- 7 days |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
45.00 Year(s) |
| Gender |
Both |
| Details |
1. Gender: Non-pregnant, non-lactating female aged between 18 to 45, with female:male ratio as 80:20
2. Subject with mild to moderate Dandruff
3. Subject willing to give written informed consent
4. Women of child bearing potential must have a negative urine pregnancy test
5. Free of any systemic and dermatologic disorder, which in the opinion of the investigator, will interface with the study results or increase the risk of AE.
6. Are willing to avoid prolonged exposure of the treatment area to ultraviolet radiation (natural or artificial) for the duration of the study.
|
|
| ExclusionCriteria |
| Details |
1. Subjects who are pregnant, breast feeding, or planning to become pregnant during the study
2. Have any evidence of systematic cancer, squamous cell carcinoma, basal cell carcinoma in the last 5 years, or any other confounding skin condition.
3. Have open sore or open lesions in the treatment area
4. Have any condition that, in the opinion of the investigator, would confound the safety and efficacy assessments of the product.
5. Have participated in any interventional clinical trial in the previous 30 days.
6. Have a known sensitivity to any of the constituents of the test product including sensitivities to any of the constituents.
7. Have used, are using, or are planning to use immunosuppressive or immunomodulatory medications (i.e., biologics), including corticosteroids.
8. Have a history of alcohol or illegal drug/ substance abuse or suspected alcohol or illegal drug/substance abuse in the past 2 years.
|
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
1. Change in Scalp Dryness/ Hydration
2. Scalp Sebum
3. Dandruff Assessment
4. Dinolite Imaging |
Time Points: At T0, T60min, T+7days |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Not Applicable |
Not Applicable |
|
|
Target Sample Size
|
Total Sample Size="32"
Sample Size from India="32"
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
|
Post Marketing Surveillance |
|
Date of First Enrollment (India)
|
23/08/2025 |
| 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="0"
Days="7" |
|
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
|
A single blind one arm study. Each participant entering the trial will be assigned to a regimen of investigational product with expected wash on Day 0, 3 and 7 with below assessments: - Scalp Dryness/hydration (corneometery) [Day0(0min, 60min) and Day 7] - Scalp Sebum [Day0(0min, 60min) and Day 7] - Dandruff assessment. [Day0(0min, 60min) and Day 7] - Dinolite Imaging [Day0(0min, 60min) and Day 7]
Volunteers- 32
|
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