| CTRI Number |
CTRI/2025/03/082878 [Registered on: 20/03/2025] Trial Registered Prospectively |
| Last Modified On: |
19/03/2025 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Other (Specify) [cosmetic] |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
A study to evaluate the effectiveness of the test product in improving scalp health over a period of 4 weeks. |
|
Scientific Title of Study
|
A clinical study to evaluate the safety and efficacy of the test product in improving
scalp health over 4 weeks in comparison to baseline. |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| HAIR/LCAD/2025-01, VERSION 1.0, DATED 24 Feb 2025 |
Protocol Number |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Sharad Nadiga |
| Designation |
Principal Investigator |
| Affiliation |
MS Clinical research |
| Address |
MS clinical research Pvt. Ltd.
327/15,
1st main road, Cambridge layout,
Ulsoor
Bangalore
KARNATAKA
560008
India |
| Phone |
08040917253 |
| Fax |
|
| Email |
sharad.nadiga@msclinical.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Mukta Sachdev |
| Designation |
Principal Investigator |
| Affiliation |
MS Clinical Research Pvt. Ltd. |
| Address |
MS Clinical Research Pvt. Ltd 327/15, 1st Main Road,
Cambridge layout, Ulsoor
Bangalore
KARNATAKA
560008
India |
| Phone |
08040917253 |
| Fax |
|
| Email |
mukta.sachdev@msclinical.com |
|
Details of Contact Person
Public Query
|
| Name |
Sudhanthiran S |
| Designation |
manager- Techno commercial |
| Affiliation |
MS Clinical research |
| Address |
MS Clinical Research Pvt. Ltd 327/15,
1st Main Road, Cambridge layout,
Ulsoor
Bangalore
KARNATAKA
560008
India |
| Phone |
09952700028 |
| Fax |
|
| Email |
sudhan@msclinical.com |
|
|
Source of Monetary or Material Support
|
| LiquidCubes InnoCommerce (LiquidCubes)
1287, 1st Floor,
16th Main, 20th Cross,
Block-A Sahakara Nagar,
Bangalore - 560092
Karnataka, India |
|
|
Primary Sponsor
|
| Name |
LiquidCubes InnoCommerce (LiquidCubes) |
| Address |
1287, 1st Floor,
16th Main, 20th Cross,
Block-A Sahakara Nagar,
Bangalore - 560092
Karnataka, India |
| 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 Sharad Nadiga |
MS Clinical Research Pvt. Ltd. |
MS Clinical Research Pvt. Ltd 327/15, Department of Hair Studies, first floor, 1st Main Road Cambridge
layout Ulsoor
Bangalore
KARNATAKA |
09952700028
sharad.nadiga@msclinical.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| ACE INDEPENDENT ETHICS COMMITTEE |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Healthy Human Volunteers |
healthy male participants |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
LC-ES-1046/020 |
sufficient amount of test product to be applied all over the head, hair and scalp followed by Washing in a standardized manner. Product application will be based on subject’s hair washing habit.
duration-4 weeks |
| Intervention |
LC-RH-1052/020 |
sufficient amount of test product to be applied all over the head, hair and scalp followed by Washing in a standardized manner. Product application will be based on subject’s hair washing habit.
duration-4 weeks |
| Intervention |
LC-SL-1045/020 |
sufficient amount of test product to be applied all over the head, hair and scalp followed by Washing in a standardized manner. Product application will be based on subject’s hair washing habit.
duration-4 weeks |
| Comparator Agent |
NIL |
NIL |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
45.00 Year(s) |
| Gender |
Male |
| Details |
1) Male subjects in general good health with scalp conditions (Dry, Itchy, Irritated, Redness, Flaking)
2) Subjects in the age group 18-45 years (both ages inclusive).
3) Subjects with moderate flakes.
4) Subjects willing to give written informed consent and willing to abide by and comply with the study protocol.
5) Subjects willing to refrain from using any other product that can impact scalp health.
|
|
| ExclusionCriteria |
| Details |
1) Subjects having any active scalp disease which may interfere with the study based on the dermatologist’s discretion.
2) Subjects who have taken chemotherapy for cancer in the 6 months prior to the start of the study.
3) Subjects who have undergone hair transplants.
4) A known history or present condition of allergic response/hypersensitivity to any hair or pharmaceutical products.
5) Subjects on oral medications like topical or systemic corticosteroids, anti-fungal, or antibiotics, or any prolonged use of non-steroidal anti-inflammatory, or anti-histaminic within 2 weeks prior to the study, undergoing any chemical hair salon treatment-straightening / perming/color/henna which will compromise the study.
6) Subjects participating in other similar trials within the last 2 weeks.
7) Subjects with any history of underlying uncontrolled medical illness including diabetes mellitus, hypertension, HIV, thyroid, hepatitis, severe anemia, serious disorder of the heart and respiratory apparatus or any other serious medical illness
8) Employees of MSCR or the sponsor.
|
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Case Record Numbers |
|
Blinding/Masking
|
Participant and Investigator Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
1) Improvement of scalp health/condition and significant reduction of the total dandruff score, Non-Adherent and Adherent flakes score evaluated by Visual assessment.
2) Reduction in oiliness and Improved scalp hydration by non-invasive instrumental assessment.
3) Efficacy of the test product in reducing flakes using the Visible Flake Assessment.
4) Change of microbiome of the scalp by product usage at week 4.
5) Improved scalp condition by microscopic imaging.
|
Baseline, week 2 and week 4 |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| 1) Improved scalp health by Subject self-assessment. |
Baseline, week 2 and week 4 |
|
|
Target Sample Size
|
Total Sample Size="90"
Sample Size from India="90"
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)
|
30/03/2025 |
| 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="1"
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 4-week monocentric clinical study aims to evaluate the effectiveness of three test products in improving scalp health. Ninety male participants, aged 18-45, will be divided across three test groups. During Visit 1 (screening), subjects will undergo acclimatization, and baseline assessments related to scalp health along with microbiome sampling and they will be instructed about the use of the test product. In Visit 2 (Week 2), product compliance will be checked, and similar assessments will be repeated. During Visit 3 (Week 4), final evaluations will be conducted, and the test products, diaries, and exit form will be collected. |