Androgenetic AlopeciaPhase 3NCT06539273
Exosome Treatment in Androgenetic Alopecia
A Phase 3 study testing Exosome Complex, RNA in people with Androgenetic Alopecia and Exosomes, run by Yeditepe University Hospital at 1 site in Turkey (Türkiye).
Trial 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. Read more about this study
- Who is it for?
- Ages 22 to 65 years, men only
- Conditions the study is for
- Androgenetic Alopecia, Exosomes
- What is being tested?
- Exosome Complex, RNA
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 1 Jan 2024to 5 May 2024
- Phase
- Phase 3
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 22 to 65 years
- Men only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Yeditepe University Kozyatagi Hospital
Istanbul, Atasehir, 34752
About this study
Official title: Effectiveness of Exosome Treatment in Androgenetic Alopecia - Outcomes of a Prospective Study
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.
Read the detailed description
Within the scope of this research, we aim 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.This prospective study included 30 male patients, aged between 22 and 65, with hair type III-VI according to the Norwood-Hamilton scale, who agreed not to change their hairstyle and would not undergo any hair care or treatment during the study.Foreskin-derived Mesenchymal Stem Cells (MSCs) were utilized, sourced from the Extracellular Vesicle and Exosome Research Laboratory (EVER Lab) at Yeditepe University.The cell culture media is collected from a combination of FBS and antibiotic-free stem cell culture. An ATPS-Exosome isolation solution is prepared by blending Polyethylene glycol (PEG) and Dextran (DEX) at a 7.7:3.3 (w/w) ratio with distilled water.
Stem cell exosome concentration measurement and determination of exosome size and density distribution were conducted using Nanosight NS300 (Malvern Instruments) equipped with a 488 nm laser.Exosomal surface antigens were assessed using Flow Cytometry.
Before the exosome injections of 30 male patients with androgenetic alopecia, frontal and vertex regions where hair loss occurred on the scalp were imaged with a digital camera.An area of 1 cm2 from each of the mentioned areas were selected and 40x magnification images of those areas were taken with digital dermatoscopyUsing these dermatoscopic images, hair densities (hair count/cm2) were recorded with Trichoscan (TrichoLab GmbH, Germany). The patients were called for control at the 4th and 12th weeks after the injection. During these sessions, photographs of the same areas were taken with the same digital camera, from the same distance and under the same light and flash (1/200 s; f/6,3; ISO 160). During the controls, same topographic points were found (2 frontal and 1 vertex points) and these areas were imaged with digital dermatoscopy under x40 magnification. Hair densities were recorded with Trichoscan analyses and the averages of the 3 treated areas were taken.
Additionally, at the 4- and 12-week check-ups, a hair growth survey, as defined by Barber at al, was modified and administered to the patients [8]. In this modified survey, patients were asked 2 questions. Question one was "Has your hair loss decreased?" while the second question was "Have you noticed new hair growing?"
- Conditions
- Androgenetic Alopecia, Exosomes
- Being tested
- Exosome Complex, RNA
- Keywords
- androgenetic alopecia, exosome, extracellular vesicles, hair density, hair loss, mesenchymal stromal cells
- Medical subject headings
- Alopecia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Exosome Complex, RNADrug
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)
| Study group | Role | What they receive |
|---|---|---|
| Experimental | Experimental | Intervention group Receives: Drug: Exosome Complex, RNA |
What is being measured
The primary outcome is the main question the study is designed to answer.
Hair density
Increase in hair density (number of hair/cm2)
Measured: 4th and 12th weeks
Secondary outcomes (1)
Patient satisfaction survey
Increase Patient satisfaction in 4th and 12th weeks
Measured: 4th and 12th weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Aug 2024
- Study start1 Jan 2024
- Primary completion30 Apr 2024
- Study completion5 May 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Androgenetic AlopeciaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 30 participants (actual)
Sponsor and investigators
- Lead sponsor
- Yeditepe University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Mert Ersan, Yeditepe University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06539273
- Sponsor's protocol ID
- YeditepeKAEK1809
- Status last verified
- Jul 2025
- First submitted
- 1 Aug 2024
- Last updated
- 16 Jul 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 16 Jul 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effectiveness of Exosome Treatment in Androgenetic Alopecia - Outcomes of a Prospective Study
- ClinicalTrials.gov ID
- NCT06539273
- Acronym / sponsor ID
- YeditepeKAEK1809
- Conditions
- Androgenetic Alopecia, Exosomes
- Keywords
- androgenetic alopecia, exosome, extracellular vesicles, hair density, hair loss, mesenchymal stromal cells
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 30 participants (actual)
- Lead sponsor
- Yeditepe University HospitalUniversity, hospital or other
- Study start
- 1 Jan 2024 (actual)
- Primary completion
- 30 Apr 2024 (actual)
- Study completion
- 5 May 2024 (actual)
- First posted
- 6 Aug 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
Within the scope of this research, we aim 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.This prospective study included 30 male patients, aged between 22 and 65, with hair type III-VI according to the Norwood-Hamilton scale, who agreed not to change their hairstyle and would not undergo any hair care or treatment during the study.Foreskin-derived Mesenchymal Stem Cells (MSCs) were utilized, sourced from the Extracellular Vesicle and Exosome Research Laboratory (EVER Lab) at Yeditepe University.The cell culture media is collected from a combination of FBS and antibiotic-free stem cell culture. An ATPS-Exosome isolation solution is prepared by blending Polyethylene glycol (PEG) and Dextran (DEX) at a 7.7:3.3 (w/w) ratio with distilled water.
Stem cell exosome concentration measurement and determination of exosome size and density distribution were conducted using Nanosight NS300 (Malvern Instruments) equipped with a 488 nm laser.Exosomal surface antigens were assessed using Flow Cytometry.
Before the exosome injections of 30 male patients with androgenetic alopecia, frontal and vertex regions where hair loss occurred on the scalp were imaged with a digital camera.An area of 1 cm2 from each of the mentioned areas were selected and 40x magnification images of those areas were taken with digital dermatoscopyUsing these dermatoscopic images, hair densities (hair count/cm2) were recorded with Trichoscan (TrichoLab GmbH, Germany). The patients were called for control at the 4th and 12th weeks after the injection. During these sessions, photographs of the same areas were taken with the same digital camera, from the same distance and under the same light and flash (1/200 s; f/6,3; ISO 160). During the controls, same topographic points were found (2 frontal and 1 vertex points) and these areas were imaged with digital dermatoscopy under x40 magnification. Hair densities were recorded with Trichoscan analyses and the averages of the 3 treated areas were taken.
Additionally, at the 4- and 12-week check-ups, a hair growth survey, as defined by Barber at al, was modified and administered to the patients [8]. In this modified survey, patients were asked 2 questions. Question one was "Has your hair loss decreased?" while the second question was "Have you noticed new hair growing?"
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Experimental | Experimental | Drug: Exosome Complex, RNAIntervention group |
Who may qualify
- Ages
- 22 to 65 years
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- 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
Key exclusion criteria (5 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Exosome Complex, RNAA 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) | Drug | Experimental |
Primary outcome
Hair density
Time frame: 4th and 12th weeks
Increase in hair density (number of hair/cm2)
1 secondary outcome
Patient satisfaction survey
Time frame: 4th and 12th weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Jul 2025.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Exosome Complex, RNA in people with Androgenetic Alopecia and Exosomes, run by Yeditepe University Hospital at 1 site in Turkey (Türkiye).
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 16 Jul 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Hair density (time frame: 4th and 12th weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 Jul 2025.