| CTRI Number |
CTRI/2025/02/080810 [Registered on: 18/02/2025] Trial Registered Prospectively |
| Last Modified On: |
04/12/2025 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Other (Specify) [HAIR GROWTH STUDY] |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
Study to Test the Safety and Effectiveness of Oilem in Reducing Dandruff and Promoting Hair Growth in Adults |
|
Scientific Title of Study
|
A study to evaluate the safety and efficacy of test product (Oilem) in reducing dandruff and improving hair growth in adult subjects |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| HAIR/SRHG/2024-02 version 1.0 dated 03 Jan 2025 |
Protocol Number |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Mukta Sachdev |
| Designation |
Principal Investigators |
| Affiliation |
MS Clinical Research Pvt. Ltd |
| Address |
MS Clinical Research Pvt. Ltd
327/15, 1st Main Road
Cambridge layout, Ulsoor
Bangalore-560008,
Karnataka, India
Bangalore
KARNATAKA
560008
India |
| Phone |
08040917253 |
| Fax |
|
| Email |
mukta.sachdev@msclinical.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Ritambhara |
| Designation |
Director business and operation |
| Affiliation |
MS Clinical Research Pvt. Ltd |
| Address |
MS Clinical Research Pvt. Ltd
327/15, 1st Main Road
Cambridge layout, Ulsoor
Bangalore-560008,
Karnataka, India
Bangalore
KARNATAKA
560008
India |
| Phone |
08040917253 |
| Fax |
|
| Email |
ritambhara@msclinical.com |
|
Details of Contact Person
Public Query
|
| Name |
Sudhanthiran S |
| Designation |
Manager techno commercial |
| Affiliation |
MS Clinical Research Pvt. Ltd |
| Address |
MS Clinical Research Pvt. Ltd
327/15, 1st Main Road
Cambridge layout, Ulsoor
Bangalore-560008,
Karnataka, India
Bangalore
KARNATAKA
560008
India |
| Phone |
08040917253 |
| Fax |
|
| Email |
sudhan@msclinical.com |
|
|
Source of Monetary or Material Support
|
| Stempeutics Research Pvt. Ltd.3rd Floor, Manipal Hospitals Whitefield #143, EPIP Industrial Area, ITPL Main Road, Bangalore - |
|
|
Primary Sponsor
|
| Name |
Stempeutics Research Pvt. Ltd. |
| Address |
3rd Floor, Manipal Hospitals Whitefield #143, EPIP Industrial Area, ITPL Main Road, Bangalore - 560 048, India |
| Type of Sponsor |
Other [Medical research and development ] |
|
|
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 Mukta Sachdev |
MS Clinical Research Pvt. Ltd, |
327/15, Room no. 1, First floor, 1st Main Road, Cambridge layout
Ulsoor, Bangalore-560008,
Karnataka, India
Bangalore
KARNATAKA |
08040917253
mukta.sachdev@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 and female participants with dandruff and hair thinning |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
NIL |
NIL |
| Intervention |
Oilem Hair care serum |
The test product will be instructed to use for period of 24 weeks. Apply sufficient amount of product evenly to one half of the scalp and follow the same on the other half of the scalp. Gently massage the scalp
for approximately 5 minutes for optimal results. |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
45.00 Year(s) |
| Gender |
Both |
| Details |
1.Male and Female subjects in general good health
2.Subjects complaining of hair fall and damage.
3.Subjects willing to give a written informed consent and willing to abide by and comply with the study protocol.
|
|
| ExclusionCriteria |
| Details |
1.Subjects who have undergone any kind of hair growth treatment in the last 1 months (self-declared).
2.Subjects who have undergone hair transplant.
3.A known history or present condition of allergic response/hypersensitivity to any topical or oral cosmetic, pharmaceutical or nutraceutical product.
8. Subjects on oral medications like topical or systemic corticosteroids, undergoing any chemical hair salon treatment-straightening / perming / colour/ henna for past 2 to 3 months which will compromise the study(self-declared) .
4.Subjects with any history of underlying uncontrolled medical illness including diabetes mellitus, hypertension, HIV, hepatitis, severe anemia, serious disorder of heart and respiratory apparatus or any other serious medical illness(self-declared).
5.Subjects participating in other similar trials within the last 2 weeks.
|
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Case Record Numbers |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| To evaluate the effectiveness of the test product in hair fall control & anti-scaling/flaking in comparison to baseline determined by dermatological and instrumental assessment. |
Day-16, Day-14, Day 0, Day 2, Day 56, Day 58, Day 112, Day 114, Day 168, Day 170
|
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| To evaluate the overall safety of the test products |
Day 0, Day 56, Day 112, Day 168 |
|
|
Target Sample Size
|
Total Sample Size="30"
Sample Size from India="30"
Final Enrollment numbers achieved (Total)= "0"
Final Enrollment numbers achieved (India)="63" |
|
Phase of Trial
|
N/A |
|
Date of First Enrollment (India)
|
21/02/2025 |
| Date of Study Completion (India) |
23/01/2026 |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Date Missing |
|
Estimated Duration of Trial
|
Years="0"
Months="6"
Days="0" |
Recruitment Status of Trial (Global)
Modification(s)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Completed |
|
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 Comparative, monocentric, safety and efficacy study aims to evaluate the effectiveness of test products in in reducing dandruff and improving hair growth in adult male and female participants, comparing the results to baseline at specific time points. At Visit 1, subjects will undergo screening based on inclusion/exclusion criteria and provide informed consent before an initial instrumental evaluation. Following this, a washout period will take place. During the next visit, baseline assessments will be performed after acclimatization, focusing on dandruff severity, itching hair thinning, quality, and density. Subjects will use the test product at home, with their compliance, adverse events, and progress monitored through subject diaries. Assessments will follow the same pattern for all 10 visits. The study duration is approximately 24 weeks for each subject, excluding the screening and washout periods. |