Various Procedural Treatment Options for Androgenetic Alopecia

NCT06826001 | Not Yet Recruiting Phase 2 DMC

• 1 other identifier: sheikh-ZMC-FH
• Study Type: interventional
• Target: 190
• Locations: 1 country
• Sites: 1

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

Conditions

Androgenetic Alopecia

Keywords

androgenetic alopecia; finasteride; minoxidil; hairloss

Outcome Measures

Primary Outcomes (1)

• COMPARISON OF EFFICACY OF TOPICAL FINESTERIDE VERSUS TOPICAL MINOXIDAL IN TREATMENT OF ANDROGENETIC ALOPECIA

  The final efficacy will be divided into following groups on the basis of Norwood-Hamilton scale from the baseline :1.Excellent efficacy: It is defined as greater than two scale change in hair density as measured from baseline . 2. moderate efficacy : It is defined as one to two scale change in hair density as measured from baseline. Percentage increase in hair density as clinically measured by the surface area from the baseline. 3.Non efficacious: It is defined as less than one scale change in hair density as measured clinically from baseline.

  Clinical assessment for efficacy will be done monthly for 6 months

Study Arms (2)

Finesteride group

ACTIVE COMPARATOR

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

Drug: topical finasteride

Minoxidil group

ACTIVE COMPARATOR

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

Drug: Topical minoxidil

Interventions

topical finasteride DRUG

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

Finesteride group

Topical minoxidil DRUG

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

Minoxidil group

Eligibility Criteria

• Age: 20 Years - 50 Years
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Sheikh Zayed Medical College: lead

Study Sites (1)

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

Rahim Yar Khan, Punjab Province, 644200, Pakistan

Location

MeSH Terms

Conditions

Alopecia

Interventions

Finasteride; Minoxidil

Condition Hierarchy (Ancestors)

Hypotrichosis; Hair Diseases; Skin Diseases; Skin and Connective Tissue Diseases; Pathological Conditions, Anatomical; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Androstenes; Androstanes; Steroids; Fused-Ring Compounds; Polycyclic Compounds; Azasteroids; Steroids, Heterocyclic; Piperidines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Pyrimidines

Central Study Contacts

Farah Humera, post graduate resident derma

CONTACT

+923328334251; drfarahumera1@gmail.com

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER GOV
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Post Graduate Resident in Dermatology

Study Record Dates

• First Submitted: January 21, 2025
• First Posted: February 13, 2025
• Study Start: February 1, 2025
• Primary Completion: July 1, 2025
• Study Completion: July 1, 2025
• Last Updated: February 13, 2025

Record last verified: 2025-02

Data Sharing

• IPD Sharing: Will not share

Locations

PA (1)