Various Procedural Treatment Options for Androgenetic Alopecia

NCT ID: NCT06826001

Last Updated: 2025-02-13

Basic Information

• Recruitment Status: NOT_YET_RECRUITING
• Clinical Phase: PHASE2
• Total Enrollment: 190 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2025-02-28
• Study Completion Date: 2025-07-31

Brief Summary

Androgenetic alopecia (AGA)is the most common form of alopecia. It predominantly affects males, but there has been a significant surge in female preponderance too, over the last decade Minoxidil belong to the anti-hypertensive class but it also affects the potassium channels present in vascular smooth muscles and hair follicles. This potassium channel activity may stimulate the microcirculation around the hair follicles and induces arteriolar vasodilation, thereby encouraging conditions conducive to hair growth Topical administration of finasteride offers the potential to reduce systemic effects related to its mechanism of action by preferentially inhibiting 5-a reductase in the scalp, as has been suggested in recent years so in this study we are going to compare efficacy of topical minoxidil versus topical finasteride in treatment of androgenetic alopecia

Detailed Description

Androgenetic alopecia (AGA)is considered to be a very common form of alopecia. Minoxidil belong to the anti-hypertensive class but it also affects the potassium channels present in vascular smooth muscles and hair follicles. This potassium channel activity may stimulate the microcirculation around the hair follicles and induces arteriolar vasodilation, thereby encouraging conditions conducive to hair growth The clinical efficacy of oral finasteride for treating AGA is well established. Although oral finasteride is generally well tolerated Topical finasteride is a medication that is used to treat hair loss in men and women. It is a topical version of the oral medication finasteride, which works by blocking the conversion of testosterone to dihydrotestosterone (DHT), a hormone that contributes to hair loss. Topical administration of finasteride offers the potential to reduce systemic effects related to its mechanism of action by preferentially inhibiting 5-a reductase in the scalp, as has been suggested in recent years.

OBJECTIVE "To compare the efficacy of topical finasteride vs topical minoxidil in the treatment of androgenetic alopecia in tertiary care hospital"

DATA COLLECTION:

Data will be collected on prescribed proforma which is attached, at Dermatology OPD, Sheikh Zayed Hospital, Rahim Yar Khan. Patient will be selected on basis of inclusion & exclusion criteria. Informed consent will be taken from selected patients before data collection. Study will include 190 patients which will be divided into 2 groups A & B, 95 in each group. Group A will receive topical finasteride spray 0.25% twice daily for 12 weeks. Group B will receive topical 5% minoxidil twice daily for 12 weeks Patient will be followed at the end of 12 weeks therapy.

DATA ANALYSIS:

Data will be analyzed by SPSS (Statistical Package for the Social Sciences) v25.0.

Conditions

Androgenetic Alopecia

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Finesteride group

Group A will receive topical finasteride spray 0.25% twice daily for 12 weeks

Group Type: ACTIVE_COMPARATOR

topical finasteride

Intervention Type: DRUG

Group A will receive topical finesteride spray 0.25% twice daily for 12 weeks

Minoxidil group

Group B will receive topical 5% minoxidil twice daily for 12 weeks

Group Type: ACTIVE_COMPARATOR

Topical minoxidil

Intervention Type: DRUG

Group B will receive topical 5% minoxidal twice daily for 12 weeks

Interventions

topical finasteride

Group A will receive topical finesteride spray 0.25% twice daily for 12 weeks

Intervention Type: DRUG

Topical minoxidil

Group B will receive topical 5% minoxidal twice daily for 12 weeks

Intervention Type: DRUG

Eligibility Criteria

Inclusion Criteria

• Age: 20-50 years
• Gender: Male
• ANDROGENETIC ALOPECIA with AGA stage 2-6 Norwood-Hamilton -classification
• Patients not taking any treatment in last 1 month

Exclusion Criteria

• Abrasion or abnormalities to the scalp
• Hair transplant
• Hypersensitivity
• Recent history of local infections of the head
• History of relevant significant disease active seborrheic dermatitis
• Concurrent use of :
• corticosteroids
• anabolic steroids or over-the-counter 'hair restorers'
• use of drugs with anti-androgenic properties within 6 months light or laser treatment of the scalp within the last 3 months.

• Minimum Eligible Age: 20 Years
• Maximum Eligible Age: 50 Years
• Eligible Sex: MALE
• Accepts Healthy Volunteers: No

Sponsors

Sheikh Zayed Medical College

OTHER_GOV

Sponsor Role: lead

Responsible Party

Farah Humera

Post Graduate Resident in Dermatology

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

Sheikh zayed Medical College and Hospital, Rahim Yar Khan, Punjab 644200

Rahim Yar Khan, Punjab Province, Pakistan

Countries

Pakistan

Central Contacts

Farah Humera, post graduate resident derma

Role: CONTACT

drfarahumera1@gmail.com

+923328334251

Facility Contacts

Sheikh zayed Medical college rahim yar khan punjab

Role: primary

info@szmc.edu.pk

+92689230168

Other Identifiers

sheikh-ZMC-FH

Identifier Type: -

Identifier Source: org_study_id