Exosome Treatment in Androgenetic Alopecia

NCT06539273 | Completed Phase 3 DMC

• 1 other identifier: YeditepeKAEK1809
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

Brief Summary

This study aims to elucidate the effect of "foreskin-derived mesenchymal stromal cells derived exosome" injection into the scalp on hair density in patients with androgenetic alopecia and the contribution of this treatment on patient satisfaction.

Conditions

Androgenetic Alopecia; Exosomes

Keywords

androgenetic alopecia; exosome; extracellular vesicles; hair density; hair loss; mesenchymal stromal cells

Outcome Measures

Primary Outcomes (1)

• Hair density

  Increase in hair density (number of hair/cm2)

  4th and 12th weeks

Secondary Outcomes (1)

• Patient satisfaction survey

  4th and 12th weeks

Study Arms (1)

Experimental

EXPERIMENTAL

Intervention group

Drug: Exosome Complex, RNA

Interventions

Exosome Complex, RNA DRUG

A total of 3 mL of exosomes (2 mL to the frontal and 1 mL to the vertex region) was injected using napage technique (10¹⁰ extracellular vesicles in 1 mL)

Experimental

Eligibility Criteria

• Age: 22 Years - 65 Years
• Gender Eligibility Details: Male patients with androgenetic alopecia
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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
• Patients who were actively pregnant, breastfeeding, or planning to become pregnant within the next 6 months

Sponsors & Collaborators

• Yeditepe University Hospital: lead

Study Sites (1)

Yeditepe University Kozyatagi Hospital

Istanbul, Atasehir, 34752, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Alopecia

Interventions

Exosome Multienzyme Ribonuclease Complex

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Multienzyme Complexes; Multiprotein Complexes; Macromolecular Substances; Ribonucleases; Esterases; Hydrolases; Enzymes; Enzymes and Coenzymes

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Asst.Prof.

Study Record Dates

• First Submitted: August 1, 2024
• First Posted: August 6, 2024
• Study Start: January 1, 2024
• Primary Completion: April 30, 2024
• Study Completion: May 5, 2024
• Last Updated: July 16, 2025

Record last verified: 2025-07

Locations

TU (1)