Androgenetic AlopeciaPhase 1/2NCT07112586
Evaluation of Exosomes Injection in Treatment of Male Androgenetic Alopecia: Clinical and Immunohistochemical Study
A Phase 1/2 study testing Plasma derived exosomes in people with Androgenetic Alopecia, run by Ain Shams University at 1 site in Egypt.
Trial summary
Intradermal injection of exosomes in treatment of male androgenetic alopecia, clinically and using a immunohistochemical marker Read more about this study
- Who is it for?
- Ages 18 to 40 years, men only
- Conditions the study is for
- Androgenetic Alopecia
- What is being tested?
- Plasma derived exosomes
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 15 participants
- Where
- 1 siteEgypt
- Study dates
- 30 Aug 2025to 31 Jan 2027
- Phase
- Phase 1/2
- Are there results?
- Not yet: the study is under way
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 18 to 40 years
- Men only
- No healthy volunteers
- Adult
Who may be able to join
- Androgenetic Alopecia Grades 1-4
Who cannot join
- blood diseases Receiving other treatments History of malignancy or allergic reaction to exosomes
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Egypt1 site
Ain Shams Univeristy Faculty of medicine
Cairo, Abbasia, 11757
Faculty of medicine ain shams university Ain shams university
About this study
Official title: Evaluation of Intradermal Exosome Injection in Treatment of Male Androgenetic Alopecia: A Clinical and Immunohistochemical Study
Intradermal injection of exosomes in treatment of male androgenetic alopecia, clinically and using a immunohistochemical marker
- Conditions
- Androgenetic Alopecia
- Being tested
- Plasma derived exosomes
- Keywords
- Androgenetic Alopecia
- Medical subject headings
- Alopecia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Plasma derived exosomesDrug
Exosomes derived from patients' plasma, centrifuged at high speeds multiple times
| Study group | Role | What they receive |
|---|---|---|
| Males 18-40 years old with androgenetic alopecia | Experimental | Males with androgenetic alopecia willing to do mesotherapy sessions Receives: Drug: Plasma derived exosomes |
What is being measured
The primary outcome is the main question the study is designed to answer.
Terminal to vellus hair ratio improvement
Counting the terminal and vellus hair counts and calculating the ratio, and comparing it between different study sessions and at follow-ups
Measured: One year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Aug 2025
- Study start30 Aug 2025 (estimated)
- Primary completion31 Jan 2026 (estimated)
- Study completion31 Jan 2027 (estimated)
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.
- More trials run by Ain Shams UniversityThe sponsor's other registered studies.
- 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 1/2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 15 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Ain Shams University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07112586
- Sponsor's protocol ID
- Fmasu MD 12 20242025
- Status last verified
- Aug 2025
- First submitted
- 1 Aug 2025
- Last updated
- 8 Aug 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 8 Aug 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of Intradermal Exosome Injection in Treatment of Male Androgenetic Alopecia: A Clinical and Immunohistochemical Study
- ClinicalTrials.gov ID
- NCT07112586
- Acronym / sponsor ID
- Fmasu MD 12 20242025
- Conditions
- Androgenetic Alopecia
- Keywords
- Androgenetic Alopecia
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 15 participants (estimated)
- Lead sponsor
- Ain Shams UniversityUniversity, hospital or other
- Study start
- 30 Aug 2025 (estimated)
- Primary completion
- 31 Jan 2026 (estimated)
- Study completion
- 31 Jan 2027 (estimated)
- First posted
- 8 Aug 2025 (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.
Intradermal injection of exosomes in treatment of male androgenetic alopecia, clinically and using a immunohistochemical marker
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Males 18-40 years old with androgenetic alopecia | Experimental | Drug: Plasma derived exosomesMales with androgenetic alopecia willing to do mesotherapy sessions |
Who may qualify
- Ages
- 18 to 40 years
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (1 listed)
- Androgenetic Alopecia Grades 1-4
Key exclusion criteria (1 listed)
- blood diseases Receiving other treatments History of malignancy or allergic reaction to exosomes
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 |
|---|---|---|
| Plasma derived exosomesExosomes derived from patients' plasma, centrifuged at high speeds multiple times | Drug | Males 18-40 years old with androgenetic alopecia |
Primary outcome
Terminal to vellus hair ratio improvement
Time frame: One year
Counting the terminal and vellus hair counts and calculating the ratio, and comparing it between different study sessions and at follow-ups
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Aug 2025.
Related trials for Androgenetic Alopecia
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Phase 3 Study to Evaluate the Efficacy and Safety of Oral Minoxidil (N1087) in Men With Androgenetic Alopecia.
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Study to Evaluate Xtressé Gummy Supplement in Women With Thinning Hair
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Evaluating the Efficacy of Platelet-rich Plasma Therapy in the Treatment of Androgenic Alopecia
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Phase 3 Clinical Trial to Evaluate the Efficacy and Safety of N1087 in Participants With Female Pattern Hair Loss (MINORA-WOMEN)
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing Plasma derived exosomes in people with Androgenetic Alopecia, run by Ain Shams University at 1 site in Egypt.
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 1 inclusion and 1 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: opening soon, as of the sponsor's last update on 8 Aug 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 Egypt. 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 combined phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Dana Ashraf Maher, Assistant lecturer (+20 1225077011, dana.maher1@outlook.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Terminal to vellus hair ratio improvement (time frame: One year). 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 8 Aug 2025.