Completed

Exosome Treatment for Hair Growth in Male Androgenetic Alopecia

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What is being tested

Exosome Complex, RNA

Drug
Who is being recruted

Alopecia+4

+ Hair Diseases

+ Hypotrichosis

From 22 to 65 Years
+7 Eligibility Criteria
See all eligibility criteria
How is the trial designed

Treatment Study

Phase 3
Interventional
Study Start: January 2024
See protocol details

Summary

Principal SponsorYeditepe University Hospital
Last updated: January 28, 2026
Sourced from a government-validated database.Claim as a partner

Study start date: January 1, 2024

Actual date on which the first participant was enrolled.

This study is looking into how an injection made from foreskin-derived mesenchymal stromal cells, specifically exosomes, affects hair growth in men with androgenetic alopecia, commonly known as male pattern baldness. It involves 30 male participants aged between 22 and 65 who are experiencing various degrees of hair loss. The main goal is to see if these injections can improve hair density and increase patient satisfaction with their hair. This study is important because it explores a new potential treatment for hair loss, which affects a significant number of men and currently has limited effective options. Participants in the study receive injections of the exosome treatment directly into the scalp areas where hair loss is occurring. Hair density is carefully measured before and after the treatment using digital imaging techniques to ensure accurate results. The measurements are taken initially and then again at 4 and 12 weeks post-treatment. Additionally, participants are asked two questions at these intervals to assess their perception of hair loss reduction and new hair growth. These steps help researchers evaluate the effectiveness of the treatment in both quantitative and qualitative ways, aiming to provide comprehensive insights into how well the exosome treatment works for improving hair growth.

Official TitleEffectiveness of Exosome Treatment in Androgenetic Alopecia - Outcomes of a Prospective Study
NCT06539273
Principal SponsorYeditepe University Hospital
Last updated: January 28, 2026
Sourced from a government-validated database.Claim as a partner

Protocol

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

30 patients to be enrolled

Total number of participants that the clinical trial aims to recruit.

Treatment Study

These studies test new ways to treat a disease, condition, or health issue. The goal is to see if a new drug, therapy, or approach works better or has fewer side effects than existing options.



Eligibility

Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.
Conditions
Criteria

Male

Biological sex of participants that are eligible to enroll.

From 22 to 65 Years

Range of ages for which participants are eligible to join.

Healthy volunteers not allowed

If individuals who are healthy and do not have the condition being studied can participate.

Conditions

Pathology

AlopeciaHair DiseasesHypotrichosisSkin DiseasesPathological Conditions, Signs and SymptomsSkin and Connective Tissue DiseasesPathological Conditions, Anatomical

Criteria

2 inclusion criteria required to participate
Male patients aged between 22 and 65, with hair type III-VI according to the Norwood-Hamilton scale,

Patients who agreed not to change their hairstyle and would not undergo any hair care or treatment during the study

5 exclusion criteria prevent from participating
Patients using finasteride, dutasteride, steroids, vasodilators, anticonvulsants, beta-receptor blockers, bronchodilators, diuretics, spironolactone, cimetidine, diazoxide, cyclosporine, ketoconazole

Patients with a history of surgery for hair loss, such as hair transplantation or scalp reduction

Patients with a history of topical steroids or hair growth solutions for hair within the last year

Patients with uncontrolled blood pressure and blood sugar levels in the last 6 months, infectious skin diseases or psychiatric disorders, a history of treatment of hyperthyroidism or hypothyroidism, aspartate aminotransferase (AST) or alanine aminotransferase (ALT) serum levels >80 mg/dL or creatinine (Cr) level >1.5 mg/dL

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Study Plan

Find out more about all the medication administered in this study, their detailed description and what they involve.
Treatment Groups
Study Objectives

One single intervention group is designated in this study

This study does not include a placebo group 

Treatment Groups

Group I

Experimental
Intervention group

Study Objectives

Primary Objectives

Secondary Objectives

Study Centers

These are the hospitals, clinics, or research facilities where the trial is being conducted. You can find the location closest to you and its status.

This study has 1 location

Suspended

Yeditepe University Kozyatagi Hospital

Istanbul, Turkey (Türkiye)Open Yeditepe University Kozyatagi Hospital in Google Maps
CompletedOne Study Center