| CTRI Number |
CTRI/2025/07/091223 [Registered on: 21/07/2025] Trial Registered Prospectively |
| Last Modified On: |
15/01/2026 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug |
| Study Design |
Randomized, Parallel Group, Active Controlled Trial |
|
Public Title of Study
|
An evaluation of safety and effectiveness of locally applied hair growth medicine for the patients with male type of baldness among men |
|
Scientific Title of Study
|
A Double Blind, Randomized, Efficacy And Tolerability Comparison Study of Topical Solution of Bimatoprost (1 percent) and Levocetirizine (1 percent) versus Minoxidil (5 percent) Topical Solution for the Treatment Of Androgenic Alopecia (AGA) |
| Trial Acronym |
Nil |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Shivaprasad Kumbar |
| Designation |
Associate Professor |
| Affiliation |
Koppal Institute of Medical Sciences |
| Address |
Department of Pharmacology, 3rd Floor, Koppal Institute of Medical Sciences, Koppal Near Kidadal Gate, Gangavthi Road Koppal
Koppal
KARNATAKA
583231
India |
| Phone |
9663772002 |
| Fax |
|
| Email |
shivaprasad.kumbar@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr T Vijayakumara Adavi |
| Designation |
Assistant Professor |
| Affiliation |
Koppal Institute of Medical Sciences |
| Address |
Room No. 22
Department of Dermatology,
District Hospital Premises, Koppal Institute of Medical Sciences, Gangavathi road Koppal, Karanataka
Opp Swami Vivekananda English Medium School,
Sadashiva Nagar, Koppal
Karnataka
Koppal
KARNATAKA
583231
India |
| Phone |
7026144635 |
| Fax |
|
| Email |
vijayadavi@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr T Vijayakumara Adavi |
| Designation |
Assistant Professor |
| Affiliation |
Koppal Institute of Medical Sciences |
| Address |
Room No. 22
Department of Dermatology,
District Hospital Premises, Koppal Institute of Medical Sciences, Gangavathi road Koppal, Karanataka
Opp Swami Vivekananda English Medium School,
Sadashiva Nagar, Koppal
Karnataka
Koppal
KARNATAKA
583231
India |
| Phone |
7026144635 |
| Fax |
|
| Email |
vijayadavi@gmail.com |
|
|
Source of Monetary or Material Support
|
| Koppal Institute of Medical Sciences,Gangavathi road Koppal, Karanataka
India-583231 |
|
|
Primary Sponsor
|
| Name |
Dr Shivaprasad Kumbar |
| Address |
Koppal Institute of Medical Sciences, Koppal
Near Kidadal Gate, Gangavthi Road Koppal -583231 |
| Type of Sponsor |
Other [Investigator Initiated] |
|
|
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 Shivaprasad Kumbar |
Koppal Institute of Medical Sciences |
Room No. 22
Department of Dermatology District Hospital premises Koppal Institute of Medical Sciences
Gangavathi Road Koppal -583231
Koppal
KARNATAKA |
9663772002
shivaprasad.kumbar@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Koppal Institute of Medical Sciences, Institutional 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 |
Minoxidil 5 percent Topical Solution |
Minoxidil 5 percent Topical Solution |
| Intervention |
PDFE-2304 |
Bimatoprost 1 percent and Levocetirizine 1 percent Topical Solution of 1 ml over the scalp using a dropper twice a day for 112 days |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Male |
| Details |
1. Men who have a presentation of androgenetic alopecia (Norwood II - V).
2. Age between 18 to 60 years of age (both inclusive).
3. Have no abnormal findings during physical examination.
4. Able to comply with the study procedures in the opinion of the PI/CI.
5. Able to give written consent for participation in the study. |
|
| ExclusionCriteria |
| Details |
1. Known hypersensitivity or idiosyncratic reaction to study formulation.
2. Clinical diagnosis of non-AGA forms of alopecia.
3. History of hair transplants.
4. Subject having dyed or bleached hair 12 months prior to study start.
5. Use of any topical product in the target region in the last 6 months.
6. A medical history of receiving chemotherapy/cytotoxic agents.
7. Uncontrolled hypertension.
8. Any dermatological disorders (eczema, psoriasis, sun damage, skin cancer).
9. Hormonal diseases such as thyroid disorders or diabetes.
10. Liver and kidney disease.
11. Smokers.
12. Drug or alcohol abuse within 12 months.
13. No written consent.
14. The receipt of an investigational product or participation in a drug research study within a period of 90 days prior to the first dose of study drug. |
|
|
Method of Generating Random Sequence
|
Stratified block randomization |
|
Method of Concealment
|
Pre-numbered or coded identical Containers |
|
Blinding/Masking
|
Participant, Investigator and Outcome Assessor Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
Change from baseline to end of the treatment in target area hair count (by dermatoscope
photo). |
Baseline, Week 16 (Day 112) |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Change from baseline to Day 56 target area hair count (by dermatoscope photo) |
Baseline, Week 8 (Day 56) |
Comparison of Subject Self-Assessment in Alopecia (SSA) Score between test product and
comparator. |
Week 16 (Day 112) |
| Target Area Hair Width (from overview photo), Target Area Hair Darkness (from overview photo) |
Week 16 (Day 112) |
| Comparison of Investigator Global Assessment (IGA) Score between test product and comparator. |
Week 16 (Day 112) |
| Global Panel Review (from overview photo) |
Week 16 (Day 112) |
| Subject health, well-being & vitals (Blood pressure, radial pulse, respiratory rate and body temperature) will be monitored and assessed at all visits |
Day 1, Week 4 (Day 28), Week 8 (Day 56), Week 12 (Day 84) & Week 16 (Day 112) |
|
|
Target Sample Size
|
Total Sample Size="15"
Sample Size from India="15"
Final Enrollment numbers achieved (Total)= "0"
Final Enrollment numbers achieved (India)="0" |
|
Phase of Trial
|
Phase 2 |
|
Date of First Enrollment (India)
|
29/07/2025 |
| Date of Study Completion (India) |
Date Missing |
| 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 is a double-blind, randomized clinical trial designed to compare the efficacy and tolerability of a novel combination topical formulation PDFE-2304, versus Minoxidil 5 percent in the treatment of Androgenic Alopecia (AGA). A total of 15 male subjects with AGA will be enrolled and randomized in a ratio of 10 subjects receiving the test product (PDFE-2304) and 5 receiving the comparator (Minoxidil 5 percent). Each participant will attend five clinic visits over the course of the study. The investigational product (PDFE-2304) is hypothesized to act on a dual mechanism to stimulate hair growth by shifting the hair cycle from telogen to anagen. Objectives: Primary Objective is to assess the efficacy and tolerability of PDFE-2304 compared with Minoxidil 5 percent in treating AGA, using target area hair count as the primary endpoint (measured by dermatoscope photography). Secondary Objectives is to assess Subject Self-Assessment (SSA) Score, Investigator Global Assessment (IGA) Score, Target Area Hair Width (TAHW), Target Area Hair Darkness (TAHD), Global Panel Review (GPR) Score. |