Various Procedural Treatment Options for Androgenetic Alopecia

February 7, 2025 updated by: Farah Humera, Sheikh Zayed Medical College

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

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

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Estimated)

190

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • Pakistan
    • Punjab
      • Rahim Yar Khan, Punjab, Pakistan, 644200
        • Sheikh zayed Medical College and Hospital, Rahim Yar Khan, Punjab 644200
        • Contact:
          • Sheikh zayed Medical college rahim yar khan punjab
          • Phone Number: +92689230168
          • Email: info@szmc.edu.pk

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult

Accepts Healthy Volunteers

No

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Finesteride group
Group A will receive topical finasteride spray 0.25% twice daily for 12 weeks
Drug: topical finasteride
Group A will receive topical finesteride spray 0.25% twice daily for 12 weeks
Active Comparator: Minoxidil group
Group B will receive topical 5% minoxidil twice daily for 12 weeks
Drug: Topical minoxidil
Group B will receive topical 5% minoxidal twice daily for 12 weeks

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
COMPARISON OF EFFICACY OF TOPICAL FINESTERIDE VERSUS TOPICAL MINOXIDAL IN TREATMENT OF ANDROGENETIC ALOPECIA
Time Frame: Clinical assessment for efficacy will be done monthly for 6 months
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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sheikh Zayed Medical College

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

February 1, 2025

Primary Completion (Estimated)

July 1, 2025

Study Completion (Estimated)

July 1, 2025

Study Registration Dates

First Submitted

January 21, 2025

First Submitted That Met QC Criteria

February 7, 2025

First Posted (Actual)

March 25, 2025

Study Record Updates

Last Update Posted (Actual)

March 25, 2025

Last Update Submitted That Met QC Criteria

February 7, 2025

Last Verified

February 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • sheikh-ZMC-FH

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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