| CTRI Number |
CTRI/2025/03/082536 [Registered on: 18/03/2025] Trial Registered Prospectively |
| Last Modified On: |
17/03/2025 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Other (Specify) [Hair growth study] |
| Study Design |
Randomized, Parallel Group, Placebo Controlled Trial |
|
Public Title of Study
|
A Study to Test the Effectiveness of Hair care Tonic for Hair Growth in Women. |
|
Scientific Title of Study
|
A randomized double-blinded clinical study to evaluate the hair growth efficacy of CosmeRNA in female subjects |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| HAIR/BNHG/2024-01 version 1.0 dated 20 Dec 2024 |
Protocol Number |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| 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-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 & 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
|
| Bioneer, 71, Techno 2-ro, Yuseong-gu, Daejeon 34013, Republic of Korea |
|
|
Primary Sponsor
|
| Name |
Bioneer |
| Address |
71, Techno 2-ro, Yuseong-gu, Daejeon 34013, Republic of Korea |
| Type of Sponsor |
Other [Biotechnology Research] |
|
|
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, Second floor, 1st Main Road Cambridge layout, Ulsoor Bangalore-560008, Karnataka, India
Bangalore
KARNATAKA |
8040917253
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 |
Female subjects with hair loss. |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
CosmeRNA ARI Intensive Anti-Hair loss Tonic |
The test product will be applied on site for period of 25 weeks.
Gently scale the scalp to remove excess buildup and ensure its completely dry before applying the product. Apply one drop at a time, massage the scalp for 30 seconds, and repeat the process until the tonic is evenly spread. |
| Comparator Agent |
Placebo |
The test product will be applied on site for period of 25 weeks.
Gently scale the scalp to remove excess buildup and ensure its completely dry before applying the product. Apply one drop at a time, massage the scalp for 30 seconds, and repeat the process until the tonic is evenly spread. |
|
|
Inclusion Criteria
|
| Age From |
30.00 Year(s) |
| Age To |
50.00 Year(s) |
| Gender |
Female |
| Details |
1) Subjects in the age group 30-50 years (both the ages inclusive).
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.
4) Subjects who agree to use regular shampoo throughout the study (shampoo without any hair growth ingredient).
5) Atleast 6 subjects, 3 subjects in each group willing to undergo Biopsy (Subjects who agree to participate in scalp biopsy have to acknowledge and understand of scalp biopsy procedure and potential risks.
|
|
| ExclusionCriteria |
| Details |
1) Subjects who have undergone any kind of hair growth treatment in the last 1 month.
2) Subjects having any active but controllable scalp disease which may interfere in the study assessments.
3) Subjects who have taken chemotherapy for cancer in the 6 months prior to the study start.
4) Subjects who have history of crash dieting and or psychiatric disorder including trichotillomania.
5) Subjects who have undergone hair transplant.
6) A known history or present condition of allergic response hypersensitivity to any topical or oral cosmetic pharmaceutical or neutraceutical product.
7) Subjects with chronic illness which may influence the cutaneous state.
8) Subjects who are pregnant or nursing (Self declared) |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Case Record Numbers |
|
Blinding/Masking
|
Participant and Investigator Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| To evaluate the effectiveness of the test product in promoting hair growth in comparison to baseline determined by dermatological and instrumental assessment. |
Day 0, Day 2, Day 14, Day 28, Day 30, Day 42, Day 56, Day 58, Day 70, Day 84, Day 86, Day 98, Day 112, Day 114, Day 140, Day 142, Day 168, Day 170 |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| To evaluate the overall safety of the test product |
Day 0, Day 2, Day 14, Day 28, Day 30, Day 42, Day 56, Day 58, Day 70, Day 84, Day 86, Day 98, Day 112, Day 114, Day 140, Day 142, Day 168, Day 170 |
|
|
Target Sample Size
|
Total Sample Size="46"
Sample Size from India="46"
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)
|
28/03/2025 |
| 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="6"
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 study involves 46 female participants who meet the inclusion and exclusion criteria and have signed informed consent. During the screening visit (Visit 1), participants will undergo a dermatological evaluation to assess their eligibility, and those qualified will be instructed on the next visit schedule. Participants will be randomized into two groups and undergo various baseline assessments, including imaging and biopsy for select subjects. Follow-up visits will include treatment sessions and periodic assessments to track the progress of the study. Site application reactions will be monitored from Visit 2 to 19, with acclimatization at each visit and ongoing evaluations of treatment effects. |