Androgenetic AlopeciaEXO-MINONCT07776015
Exosome Injection Versus Topical Minoxidil for Androgenetic Alopecia
A study testing exosomes injection and Topical Minoxidil 5% in people with Androgenetic Alopecia and Exosomes, run by Tanta University at 1 site in Egypt.
Trial summary
Androgenetic alopecia (AGA) is a common form of hair loss characterized by progressive hair follicle miniaturization. This prospective randomized comparative study evaluates the efficacy and safety of intradermal exosome injections compared with 5% topical minoxidil in patients with AGA. Read more about this study
- Who is it for?
- Ages 18 to 55 years
- Conditions the study is for
- Androgenetic Alopecia, Exosomes
- What is being tested?
- exosomes injection and Topical Minoxidil 5%
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 siteEgypt
- Study dates
- 20 Apr 2023to 31 Dec 2025
- Phase
- Interventional
- 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 18 to 55 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- Were male or female patients with a confirmed diagnosis of androgenetic alopecia (AGA).
- Had not received any treatment for AGA for at least 6 months before study initiation.
- Provided written informed consent. Agreed to attend the scheduled follow-up assessments and undergo photographic documentation.
Who cannot join
- Concurrent scalp diseases. A history of bleeding disorders. Current use of anticoagulant medications. Known keloidal tendency. History of psoriasis or lichen planus. Significant cardiac, hepatic, or renal disease. Any major systemic illness. Pregnancy or lactation.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Prospective, Randomized, Comparative Study of the Efficacy and Safety of Intradermal Exosome Injections Versus Topical Minoxidil in Patients With Androgenetic Alopecia
Androgenetic alopecia (AGA) is a common form of hair loss characterized by progressive hair follicle miniaturization. This prospective randomized comparative study evaluates the efficacy and safety of intradermal exosome injections compared with 5% topical minoxidil in patients with AGA. Forty patients were randomly assigned to receive either intradermal exosome injections or topical minoxidil for three months, with clinical, trichoscopic, patient-reported, and safety outcomes assessed at baseline, after treatment, and at 3-month follow-up.
Read the detailed description
Androgenetic alopecia is the most common form of hair loss and is associated with progressive shortening of the anagen phase and miniaturization of hair follicles. Conventional treatments such as topical minoxidil have variable efficacy and require continued use to maintain results. Exosome-based therapy has emerged as a potential regenerative approach because exosomes can deliver bioactive molecules that may stimulate hair follicle activity and promote the anagen phase.
This prospective, randomized, comparative study included 40 patients with confirmed androgenetic alopecia recruited from the Dermatology and Venerology Department outpatient clinic at Tanta University Hospitals. Participants were randomly allocated using a computer-generated sequence into two equal groups of 20 patients each. Group A received intradermal injections of adipose-derived mesenchymal stem cell exosomes every four weeks for three months, while Group B applied 5% topical minoxidil twice daily for three months.
Treatment efficacy was evaluated using clinical assessment, standardized scalp photography, the Global Aesthetic Improvement Scale (GAIS), trichoscopic assessment of hair density and shaft diameter, and histopathological/immunohistochemical evaluation in biopsied patients. Patient satisfaction and adverse events were also recorded. Assessments were performed at baseline, immediately after the 3-month treatment period, and after a further 3-month follow-up period.
The study aims to provide comparative clinical evidence regarding the efficacy and safety of intradermal exosome therapy versus topical minoxidil for androgenetic alopecia. The protocol received approval from the Institutional Review Board of Tanta University (Approval Code: 36264MS541/3/24), and written informed consent was obtained from all participants.
- Conditions
- Androgenetic Alopecia, Exosomes
- Being tested
- exosomes injection, Topical Minoxidil 5%
- Keywords
- androgenetic alopecia, minoxidil, exosomes
- Medical subject headings
- Alopecia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
exosomes injectionOther
intradermal injections of 1 mL of Exomide
Topical Minoxidil 5%Drug
5% topical minoxidil solution
| Study group | Role | What they receive |
|---|---|---|
| Exosome Injection | Active comparator | intradermal injections of 1 mL of Exomide Receives: Other: exosomes injection |
| topical minoxidil | Active comparator | 5% topical minoxidil solution Receives: Drug: Topical Minoxidil 5% |
What is being measured
The primary outcome is the main question the study is designed to answer.
Global Aesthetic Improvement Scale (GAIS) score
Clinical improvement was assessed by three blinded dermatologists using the GAIS, categorized as Poor (0-25%), Moderate (26-50%), Marked (51-75%), or Excellent (76-100%).
Measured: Baseline, immediately after treatment (3 months), and 3-month follow-up.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Aug 2026
- Study start20 Apr 2023
- Primary completion30 May 2024
- Study completion31 Dec 2025
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 Tanta 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 N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 40 participants (actual)
Sponsor and investigators
- Lead sponsor
- Tanta University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Nesrin Sabry, Tanta University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07776015
- Sponsor's protocol ID
- 36264MS541/3/24
- Acronym
- EXO-MINO
- Status last verified
- Aug 2026
- First submitted
- 16 Aug 2026
- Last updated
- 20 Aug 2026
- 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 20 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Prospective, Randomized, Comparative Study of the Efficacy and Safety of Intradermal Exosome Injections Versus Topical Minoxidil in Patients With Androgenetic Alopecia
- ClinicalTrials.gov ID
- NCT07776015
- Acronym / sponsor ID
- EXO-MINO / 36264MS541/3/24
- Conditions
- Androgenetic Alopecia, Exosomes
- Keywords
- androgenetic alopecia, minoxidil, exosomes
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 40 participants (actual)
- Lead sponsor
- Tanta UniversityUniversity, hospital or other
- Study start
- 20 Apr 2023 (actual)
- Primary completion
- 30 May 2024 (actual)
- Study completion
- 31 Dec 2025 (actual)
- First posted
- 20 Aug 2026 (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.
Androgenetic alopecia (AGA) is a common form of hair loss characterized by progressive hair follicle miniaturization. This prospective randomized comparative study evaluates the efficacy and safety of intradermal exosome injections compared with 5% topical minoxidil in patients with AGA. Forty patients were randomly assigned to receive either intradermal exosome injections or topical minoxidil for three months, with clinical, trichoscopic, patient-reported, and safety outcomes assessed at baseline, after treatment, and at 3-month follow-up.
Detailed description
Androgenetic alopecia is the most common form of hair loss and is associated with progressive shortening of the anagen phase and miniaturization of hair follicles. Conventional treatments such as topical minoxidil have variable efficacy and require continued use to maintain results. Exosome-based therapy has emerged as a potential regenerative approach because exosomes can deliver bioactive molecules that may stimulate hair follicle activity and promote the anagen phase.
This prospective, randomized, comparative study included 40 patients with confirmed androgenetic alopecia recruited from the Dermatology and Venerology Department outpatient clinic at Tanta University Hospitals. Participants were randomly allocated using a computer-generated sequence into two equal groups of 20 patients each. Group A received intradermal injections of adipose-derived mesenchymal stem cell exosomes every four weeks for three months, while Group B applied 5% topical minoxidil twice daily for three months.
Treatment efficacy was evaluated using clinical assessment, standardized scalp photography, the Global Aesthetic Improvement Scale (GAIS), trichoscopic assessment of hair density and shaft diameter, and histopathological/immunohistochemical evaluation in biopsied patients. Patient satisfaction and adverse events were also recorded. Assessments were performed at baseline, immediately after the 3-month treatment period, and after a further 3-month follow-up period.
The study aims to provide comparative clinical evidence regarding the efficacy and safety of intradermal exosome therapy versus topical minoxidil for androgenetic alopecia. The protocol received approval from the Institutional Review Board of Tanta University (Approval Code: 36264MS541/3/24), and written informed consent was obtained from all participants.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Exosome Injection | Active comparator | Other: exosomes injectionintradermal injections of 1 mL of Exomide |
| topical minoxidil | Active comparator | Drug: Topical Minoxidil 5%5% topical minoxidil solution |
Who may qualify
- Ages
- 18 to 55 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- Were male or female patients with a confirmed diagnosis of androgenetic alopecia (AGA).
- Had not received any treatment for AGA for at least 6 months before study initiation.
- Provided written informed consent. Agreed to attend the scheduled follow-up assessments and undergo photographic documentation.
Key exclusion criteria (1 listed)
- Concurrent scalp diseases. A history of bleeding disorders. Current use of anticoagulant medications. Known keloidal tendency. History of psoriasis or lichen planus. Significant cardiac, hepatic, or renal disease. Any major systemic illness. Pregnancy or lactation.
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 |
|---|---|---|
| exosomes injectionintradermal injections of 1 mL of Exomide | Other | Exosome Injection |
| Topical Minoxidil 5%5% topical minoxidil solution | Drug | topical minoxidil |
Primary outcome
Global Aesthetic Improvement Scale (GAIS) score
Time frame: Baseline, immediately after treatment (3 months), and 3-month follow-up.
Clinical improvement was assessed by three blinded dermatologists using the GAIS, categorized as Poor (0-25%), Moderate (26-50%), Marked (51-75%), or Excellent (76-100%).
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 20 Aug 2026.
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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 study testing exosomes injection and Topical Minoxidil 5% in people with Androgenetic Alopecia and Exosomes, run by Tanta 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 3 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: finished, as of the sponsor's last update on 20 Aug 2026. 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.
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?
Global Aesthetic Improvement Scale (GAIS) score (time frame: Baseline, immediately after treatment (3 months), and 3-month follow-up.). 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 20 Aug 2026.