CTRI

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CTRI Number

CTRI/2025/10/095857 [Registered on: 09/10/2025] Trial Registered Prospectively

Last Modified On:

09/10/2025

Post Graduate Thesis

Yes

Type of Trial

Interventional

Type of Study

Drug

Study Design

Randomized, Parallel Group, Active Controlled Trial

Public Title of Study

A COMPARISON OF EFFECTIVE TREATMENT OF 5%TOPICAL MINOXIDIL VERSUS 5% TOPICAL MINOXIDIL AND 0.25% FINASTERIDE FOR HAIR LOSS IN MEN

Scientific Title of Study

A RANDOMIZED, COMPARATIVE, OPEN, INTERVENTIONAL STUDY OF EFFICACY OF 5%TOPICAL MINOXIDIL VERSUS COMBINATION OF 5% TOPICAL MINOXIDIL AND 0.25% TOPICAL FINASTERIDE IN ANDROGENIC ALOPECIA.

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 Deepika lakshmi P
Designation	PG Student
Affiliation	ACS Medical college and Hospital
Address	Department of Pharmacology ,ACS Medical college, Velappanchavadi ,Chennai , India Thiruvallur TAMIL NADU 600077 India
Phone	9840357766
Fax
Email	deepika.paradhaman@gmail.com

Details of Contact Person
Scientific Query

Name	DR Sridevi S A
Designation	Professor
Affiliation	ACS Medical college and Hospital
Address	Department of Pharmacology ,ACS Medical college, Velappanchavadi ,Chennai ,India Thiruvallur TAMIL NADU 600077 India
Phone	9884477103
Fax
Email	sridevidakshya@gmail.com

Details of Contact Person
Public Query

Name	DR Sridevi S A
Designation	Professor
Affiliation	ACS Medical college and Hospital
Address	Department of Pharmacology ,ACS Medical college, Velappanchavadi ,Chennai ,India TAMIL NADU 600077 India
Phone	9884477103
Fax
Email	sridevidakshya@gmail.com

Source of Monetary or Material Support

ACS Medical college and Hospital velappanchavadi Thiruvallur district Tamil nadu India Chennai 600077

Primary Sponsor

Name	DR Deepika lakshmi P
Address	Bajanai koil street , parivakkam, chennai , India 600056
Type of Sponsor	Other [Self]

Details of Secondary Sponsor

Name	Address
NIL	NIL

Countries of Recruitment

India

Sites of Study

No of Sites = 1
Name of Principal Investigator	Name of Site	Site Address	Phone/Fax/Email
DR Deepika lakshmi P	ACS Medical and Hospital	No 11 , first floor ,department of pharmacology , velappanchavadi , chennai , India , 600077 Thiruvallur TAMIL NADU	9840357766 deepika.parandhaman@gmail.com

Details of Ethics Committee

No of Ethics Committees= 1
Name of Committee	Approval Status
MGR institute (ACS Medical college)	Approved

Regulatory Clearance Status from DCGI

Status

Not Applicable

Health Condition / Problems Studied

Health Type	Condition
Patients	(1) ICD-10 Condition: L639\|\|Alopecia areata, unspecified,

Intervention / Comparator Agent

Type	Name	Details
Comparator Agent	0.25% Finasteride and 5% Minoxidil	Male patients aged 25-45 years diagnosed with Androgenic Alopecia will be divided randomly into 2 groups. Group A will be given topical 5% Minoxidil twice daily and Group B will be given combination of topical 5% Minoxidil and topical 0.25% of finasteride twice daily. They will be assessed regularly through global photography and trichoscopy. Primary outcome will be change in hair density and hair diameter.
Intervention	5% Minoxidil	Male patients aged 25-45 years diagnosed with Androgenic Alopecia will be divided randomly into 2 groups. Group A will be given topical 5% Minoxidil twice daily and Group B will be given combination of topical 5% Minoxidil and topical 0.25% of finasteride twice daily. They will be assessed regularly through global photography and trichoscopy. Primary outcome will be change in hair density and hair diameter.

Inclusion Criteria

Age From	25.00 Year(s)
Age To	45.00 Year(s)
Gender	Male
Details	Men with the age group between 25-45 years. Men with Androgenic Alopecia. Patients who have given their consent.

ExclusionCriteria

Details

Men above 45 years of age with androgenic alopecia.
Men with any chronic medical disorders and those on medications within the last 6 months.
Men with other dermatological disorders of the scalp.
Men who have not given consent.

Method of Generating Random Sequence

Random Number Table

Method of Concealment

Alternation

Blinding/Masking

Open Label

Primary Outcome

Outcome	TimePoints
Compare the efficacy of 5% topical minoxidil versus combination of 5% topical minoxidil and 0.25% topical finasteride in male patients with androgenic alopecia. It will be assessed through global photography. Primary outcome will be change in hair density and hair diameter	12 weeks

Secondary Outcome

Outcome	TimePoints
nil	nil

Target Sample Size

Total Sample Size="52"
Sample Size from India="52"
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 4

Date of First Enrollment (India)

26/10/2025

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 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

Male patients aged 25-45 years diagnosed with Androgenic Alopecia will be divided randomly into 2 groups. Group A will be given topical 5% Minoxidil twice daily and Group B will be given combination of topical 5% Minoxidil and topical 0.25% of finasteride twice daily. They will be assessed regularly through global photography and trichoscopy. Primary outcome will be change in hair density and hair diameter.