| CTRI Number |
CTRI/2023/08/056656 [Registered on: 21/08/2023] Trial Registered Prospectively |
| Last Modified On: |
18/08/2023 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Other (Specify) [Topical treatment and nutritional supplements] |
| Study Design |
Randomized, Parallel Group, Placebo Controlled Trial |
|
Public Title of Study
|
To check the efficacy of holistic hair treatment in treating hair loss |
|
Scientific Title of Study
|
A Randomized, Single-Blinded, Parallel, Controlled Clinical Study to Evaluate the Efficacy and Safety of test regime in male participants with Androgenic alopecia. |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| HAIR/THHG/2023-01 Version 1.0 dated 28 Jul 2023 |
Protocol Number |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Mukesh Ramnane |
| Designation |
Principal Investigator |
| Affiliation |
MS Clinical Research Pvt Ltd |
| Address |
2nd floor, Evaluation room,327/15, 1st Main Road Cambridge layout, Ulsoor
Bangalore
KARNATAKA
560008
India |
| Phone |
08041125934 |
| Fax |
08040917253 |
| Email |
mukesh.ramnane@msclinical.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Mukesh Ramnane |
| Designation |
Principal Investigator |
| Affiliation |
MS Clinical Research Pvt Ltd |
| Address |
2nd floor, Evaluation room,327/15, 1st Main Road Cambridge layout, Ulsoor
Bangalore
KARNATAKA
560008
India |
| Phone |
08041125934 |
| Fax |
08040917253 |
| Email |
mukesh.ramnane@msclinical.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Mukesh Ramnane |
| Designation |
Principal Investigator |
| Affiliation |
MS Clinical Research Pvt Ltd |
| Address |
2nd floor, Evaluation room,327/15, 1st Main Road Cambridge layout, Ulsoor
Bangalore
KARNATAKA
560008
India |
| Phone |
08041125934 |
| Fax |
08040917253 |
| Email |
mukesh.ramnane@msclinical.com |
|
|
Source of Monetary or Material Support
|
| Arete Services Pvt Ltd C7/67, fortune hotel galaxy compound, GIDC Vapi-396195, Gujrat |
|
|
Primary Sponsor
|
| Name |
Arete Services Pvt Ltd |
| Address |
C7/67, fortune hotel galaxy compound, GIDC Vapi-396195, Gujrat |
| Type of Sponsor |
Other [Cosmetic industry] |
|
|
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 Mukesh Ramnane |
MS Clinical Research Pvt. Ltd |
Second floor, Evaluation room,327/15, 1st Main Road Cambridge layout, Ulsoor
Bangalore
KARNATAKA |
08041125934
08040917253
mukesh.ramnane@msclinical.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Clinicom Ethics Committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: L649||Androgenic alopecia, unspecified, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Placebo |
1mL morning and 1mL night, should be applied on the scalp.
Duration: 8 months |
| Intervention |
Test regime including topical solution, hair shampoo, hair oil and dietary supplements |
Topical solution: 1mL morning and 1mL night, should be applied on the scalp. Hair shampoo: As per regular regime. Hair oil: As per regular regime. Dietary supplements: As per physicians direction.
Duration: 8 months |
| Comparator Agent |
Test serum |
1mL morning and 1mL night, should be applied on the scalp. Duration: 8 months |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
45.00 Year(s) |
| Gender |
Male |
| Details |
A willing participant must fulfill the following criteria to be eligible for participation in the study:
1. Male Patients aged 18 to 45 years with male pattern hair loss (Androgenetic Alopecia) of stage 2-4 as per Norwood scale.
2. Subjects willing to provide written informed consent, indicating that they thoroughly understand the purpose and procedures required for the study and are willing to participate in the study.
3. Patients willing to have a mark in the target area.
4. Patient’s willingness to maintain same hair length. |
|
| ExclusionCriteria |
| Details |
A willing study participant will be excluded from the study, if any of the following criteria is noted:
1. Clinically relevant abnormal physical findings which could interfere with the aim of the study; in particular, skin damage such as skin abrasion, actinic keratosis or any abnormal findings in the scalp.
2. Clinically significant dandruff
3. Active unstable thyroid disease, including subjects on therapy for either hyperthyroidism or hypothyroidism unless their dose of thyroid medication has been stable for atleast 3 months.
4. Suspicion of malignancy, including prostate cancer.
5. Patients who had hair transplant surgery or hair weaving.
6. Patient who had light or laser treatment on the scalp.
7. History or evidence of hair loss other than Androgenetic Alopecia (e.g. due to auto-immune, endocrine, mechanical or infectious process or secondary to a scalp dermatological disorder).
8. Patients with active seborrheic dermatitis.
9. History of varicocele.
10. Clinically relevant abnormal laboratory values indicative of physical illness.
11. Ascertained or presumptive hypersensitivity to the active formulations or any of the excipients.
12. Patient with significant clinical relevant endocrinal, cerebrovascular, skin, pulmonary, haematological, immunological and cardiovascular disease could lead to safety risk.
13. Concurrent use of systemic corticosteroids, topical corticosteroids in the balding are studied, anabolic steroids, over-the-counter.
14. Use of the drugs with anti-androgenic properties within 6 months of study entry.
15. Patient had major surgery within 2 months prior to study entry, or who have not recovered from prior major surgery.
16. Participation in a drug research study within past 3 months. |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Case Record Numbers |
|
Blinding/Masking
|
Investigator Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| The primary objective is to evaluate & compare the efficacy of the test regime with the test serum along with placebo as per Trichoscan® measurement including growth rate & hair density (hair per cm2 of test area) |
Baseline (month 0), month 2, month 4, month 6 & month 8 |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
1. To evaluate hair density within per cm2 of test area in comparison to baseline, month 2, month 4, month 6 & month 8 using instrumental and dermatological assessments
2. To evaluate and compare the hair thickness at baseline, month 2, month 4, month 6 and month 8 using Trichoscan®
3. To evaluate and compare reduction in Hair thinning using Norwood scale and photonumerical scale MSCR.
4. To assess product tolerance and acceptance in a long- term use for 8 months. |
Baseline (month 0), month 2, month 4, month 6 & month 8 |
|
|
Target Sample Size
|
Total Sample Size="135"
Sample Size from India="135"
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)
|
29/08/2023 |
| 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="8"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Yet Recruiting |
| 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
|
The
participants who satisfy the inclusion and exclusion criteria will be enrolled
prior to the trial after obtaining the informed consent form. 135 healthy male
participants will be enrolled, so that 120 participants i.e. 40 in each group,
complete the study. Selected participants will enter a washout period of two
weeks. During this period the participants will be instructed to discontinue
the usage of all hair care medications or topical products which is known to
have hair growth effects. Participants will be asked to visit the study center
on Day 1 for baseline assessments. Baseline assessment like dermatological
assessments, Trichoscan imaging will be performed. This visit will also include
shaving of the test area. The subjects will have to visit the site on day 3 for
the phototrichogram assessment. There
will be three groups. The selected subjects will be provided with the either of
three regimes based on the randomization. The subjects will be instructed to
apply (topical products)/consume (supplements) the test product for 8 months.
The participants will be randomised and will be assigned to one of the three
groups:
1. Test regime- Customised regime including
test serum
2. Test serum
3. Placebo
Participants
will be asked to visit the study center on Day 2 (visit-3). Follow-up
assessments will be performed at M2, M4 M6 and M8 where each assessment
schedule will have 2 visits, 2 days apart (+2 days visit will done for
Trichoscan imaging). This visit consists of Dermatological Assessment for
Safety, Trichoscan® Imaging, Digital Imaging, Microscopic & Digital
Imaging.
|