| CTRI Number |
CTRI/2025/05/087404 [Registered on: 22/05/2025] Trial Registered Prospectively |
| Last Modified On: |
03/01/2026 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
To Compare Efficacy and Safety of Minoxidil and Finasteride Cutaneous Spray Solution against Regaine® Cutaneous Spray Solution in Male Subjects with Androgenetic Alopecia. |
|
Scientific Title of Study
|
A Randomised, Double-Blind, Multicentre, Parallel-Group, Phase III, Clinical Study to
Compare Efficacy and Safety of Topical Fixed Dose Combination of Minoxidil (5 percentage w/v) and
Finasteride (0.1 percentage w/v) Cutaneous Spray Solution against Regaine® (5 percentage w/v) Cutaneous Spray Solution in Male Subjects with Androgenetic Alopecia. |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| ECTS24008, Version 00, Date: 06 NOV 2024 |
Protocol Number |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Milan Satia |
| Designation |
Managing Director |
| Affiliation |
Ethicare Clinical Trial Services (OPC) Pvt. Ltd. |
| Address |
Block F-1101 to 1110, Prahlad Nagar Trade Center (PNTC), Radio Mirchi Road, Nr. Vastrapur Railway Crossing,
Ahmadabad
GUJARAT
380015
India |
| Phone |
9825585119 |
| Fax |
|
| Email |
milansatia@ethicare-cro.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Milan Satia |
| Designation |
Managing Director |
| Affiliation |
Ethicare Clinical Trial Services (OPC) Pvt. Ltd. |
| Address |
Block F-1101 to 1110, Prahlad Nagar Trade Center (PNTC), Radio Mirchi Road, Nr. Vastrapur Railway Crossing,
Ahmadabad
GUJARAT
380015
India |
| Phone |
9825585119 |
| Fax |
|
| Email |
milansatia@ethicare-cro.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Milan Satia |
| Designation |
Managing Director |
| Affiliation |
Ethicare Clinical Trial Services (OPC) Pvt. Ltd. |
| Address |
Block F-1101 to 1110, Prahlad Nagar Trade Center (PNTC), Radio Mirchi Road, Nr. Vastrapur Railway Crossing,
Ahmadabad
GUJARAT
380015
India |
| Phone |
9825585119 |
| Fax |
|
| Email |
milansatia@ethicare-cro.com |
|
|
Source of Monetary or Material Support
|
| Verisfield SMSA, 8 Vironos str., GR-152 31 Halandri, Greece |
|
|
Primary Sponsor
|
| Name |
Verisfield SMSA |
| Address |
8 Vironos str., GR-152 31 Halandri, Greece |
| Type of Sponsor |
Pharmaceutical industry-Global |
|
|
Details of Secondary Sponsor
|
| Name |
Address |
| Ms Ethicare Clinical Trial Services OPC Pvt Ltd |
F-Block, 1101-1110, PNTC Building, Radio Mirchi Road, Vejalpur, Ahmedabad, Gujarat (IndiA) |
|
|
Countries of Recruitment
|
India |
Sites of Study
Modification(s)
|
| No of Sites = 5 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr Harsh B Amin |
Adorn Aesthetic Clinic |
1st floor, OPD room, house of Adorn - opposite Reliance JIO Petrol-pump, Ambawadi Circle, Landmark: besides Shakuntal apartment
Ahmadabad
GUJARAT |
8984800800
harsh.plasticsurgery@gmail.com |
| Dr ShilpaK |
Bangalore Medical College and Research Institute (BMCRI) |
New OPD Building , 1st floor, OPD Room 01, Bangalore Medical College and Research Institute (BMCRI)/ Victoria Hospital, Fort, Krishna Rajendra Rd, Bengaluru, Urban-Karnataka
Bangalore
KARNATAKA |
9886553646
shilpakvinod1980@gmail.com |
| Dr Raj kumar Kothiwala |
Jawahar Lal Nehru Medical College |
JLN Hospital, department of dermatology, 34/C, ground floor, OPD building, Jawahar Lal Nehru Medical College, Kala Bagh, Ajmer, Rajasthan
Ajmer
RAJASTHAN |
9414118811
doctor.rajkumark@gmail.com |
| Dr Shashi Kumar |
Mandya Institute of Medical Science |
Ground floor, room no. 05, department of dermatology, Mysuru Banglore Highway,Mandya-571403
Bangalore
KARNATAKA |
9886197907
Shashi_b_m@yahoo.com |
| Dr Hardik Pitroda |
Renove Skin and Hair Clinic |
Room no. 01, 6th floor 608, Copperleaf Building, Sola Road, Landmark: Beside Solaris School & Near Bhuyangdev Char Rasta
Ahmadabad
GUJARAT |
9313975824
drhardikpitroda@gmail.com |
|
Details of Ethics Committee
Modification(s)
|
| No of Ethics Committees= 5 |
| Name of Committee |
Approval Status |
| Ethics Committee of BMCRI Bangalore Medical College and Research Institute |
Approved |
| Institution Ethics Committee, MIMS |
Approved |
| Institutional Ethics Committee, Jawahar Lal Nehru Medical College |
Approved |
| Mahavir Hospital Ethics Committee (Adorn Aesthetic Clinic) |
Approved |
| Mahavir Hospital Ethics Committee (Renove Skin and Hair Clinic) |
Approved |
|
Regulatory Clearance Status from DCGI
Modification(s)
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Healthy Human Volunteers |
Androgenetic Alopecia |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Minoxidil + Finasteride/Verisfield
cutaneous.spray solution. [50 mg/ml (5%) Minoxidil + 1 mg/ml (0.1%) Finasteride] |
Spray 2 mL solution (morning and evening) for 24 weeks. |
| Comparator Agent |
Regaine® [50 mg/mL (5%) w/v] cutaneous solution |
Spray 2 mL solution (morning and evening) for 24 weeks. |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
41.00 Year(s) |
| Gender |
Male |
| Details |
1) Male subjects with age between 18 to 41 years old (both inclusive).
2) Subjects must have a clear diagnosis of mild to moderate androgenetic alopecia (Stage II to V of the Norwood-Hamilton classification).
3) Subjects who have used Minoxidil 5% w/v topical solution in the past for at least 6 consecutive months but have responded insufficiently.
4) Subject who have willingness to maintain the same hairstyle, length and hair colour of the scalp throughout the study.
5) Subjects must be willing to provide written informed consent to participate in the study and comply with study procedures throughout study. |
|
| ExclusionCriteria |
| Details |
1) Subjects who are undergoing hair growth or transplant treatment 3 months before screening into the study.
2) Subjects with following comorbidities, if clinically significant:
- Concomitant scalp diseases with the possibility of interfering with the clinical study related evaluation methods such as fungal or bacterial infections, seborrheic dermatitis, psoriasis, eczema, folliculitis, scars or scalp atrophy
- Severe cardiovascular diseases
- Renal diseases
- Liver diseases
- Neurological disease
- Lung disease
- Psychiatric disorder
- History of hypersensitivity to any ingredients in the solution
- clinical findings identified during the clinical examination or laboratory tests that somehow prevent participation in the study
3) Subjects who have received Finasteride in the last 6 months.
4) Subjects who are taking any other medicinal or supplement product that may affect hair growth except topical minoxidil.
5) Subjects with a history of alcohol or drug addiction.
6) Subjects with history of HIV, HBV and HCV.
7) Subjects who are on oral medications or suffering from chronic illness which will compromise the study.
8) Subjects who had treatment of cancer chemotherapy last 6 months before starting study or have a plan of treatment during the study term.
9) Subjects who have active hair loss or history within the past 3 months of hair loss other than androgenic alopecia, including diffuse telogen effluvium, alopecia areata, scarring alopecia.
10) Any severe, acute or chronic medical condition that may lead to hair loss or interfere with the interpretation of trial results.
11) Subjects who have enrolled in any other investigational medication study currently, or within the last 30 days of screening.
12) Current use or history of use of systemic treatment (drugs or dietary supplement) taken for more than 2 consecutive weeks interfering with the study product or evaluations (including but not limited to Beta blockers, Cimetidine, Diazoxide, Isotretinoin, corticosteroids, Vitamin A intake above 10000 IU per day) within past 3 months.
13) Current use or history of use of local treatment (drug or cosmetically) on scalp interfering with the study product or evaluation (topical corticosteroids, hair growth formulation, medicated shampoos, topical estrogen, topical Ketoconazole) within past 4 weeks.
|
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Pre-numbered or coded identical Containers |
|
Blinding/Masking
|
Participant and Investigator Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Mean change in hair density (by Trichoscopy) |
Baseline and week 24 |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Mean change in the hair diameter (by Trichoscopy) |
Baseline and week 24 |
| Mean change in global photographic assessment score (GPAS) |
Baseline and week 24 |
Mean change in stages of scalp baldness (by Norwood-Hamilton
classification) |
Baseline and week 24 |
Absolute and percentage change in dihydrotestosterone (DHT)
levels. |
Baseline and week 24 |
| Difference in number and frequency of adverse events |
Till week 24 |
Comparison of proportion of subjects having clinically significant change in laboratory parameters between test group vs reference group
|
Baseline and week 24 |
| Local tolerability assessment |
At week 8, week 16 and week 24 |
|
|
Target Sample Size
|
Total Sample Size="120"
Sample Size from India="120"
Final Enrollment numbers achieved (Total)= "120"
Final Enrollment numbers achieved (India)="120" |
|
Phase of Trial
|
Phase 3 |
|
Date of First Enrollment (India)
|
22/08/2025 |
| Date of Study Completion (India) |
31/12/2025 |
| 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 study will be conducted to compare efficacy and safety of topical fixed dose combination of Minoxidil (5% w/v) and Finasteride (0.1% w/v) Cutaneous Spray Solution against Regaine® (5% w/v) Cutaneous Spray Solution in male subjects with androgenetic alopecia. Subjects who meet all inclusion criteria and none of the exclusion criteria based on medical history will be recruited in the study.
The subjects will be randomized in the ratio of 1:1. They will either receive test product Arm 1: Minoxidil + Finasteride/Verisfield cutaneous. Spray solution. [50 mg/ml (5%) Minoxidil + 1 mg/ml (0.1%) Finasteride] or Arm 2: Regaine® (5% w/v) cutaneous solution. Primary end point will be mean change in hair density (by Trichoscopy). Secondary end point will be mean change in the hair diameter (by Trichoscopy), mean change in global photographic assessment score, mean change in stages of scalp baldness, absolute and percentage change in dihydrotestosterone (DHT) levels, difference in number and frequency of adverse events, comparison of proportion of subjects having clinically significant change in laboratory parameters between test group vs reference group and local tolerability assessment. |