Androgenetic AlopeciaNCT07248410
A Split-Scalp Study Evaluating the Efficacy and Safety of Fractional Laser Therapy With and Without Exosomes in the Treatment of Androgenetic Alopecia
A study testing fraction laser in people with Androgenetic Alopecia, run by Chang Gung Memorial Hospital at 1 site in Taiwan.
Trial summary
This trial aims to evaluate the efficacy, safety, and tolerability of fractional laser combined with topical exosome for hair regrowth in patients with androgenetic alopecia. This study is expected to recruit 30 participants. Read more about this study
- Who is it for?
- Ages 18 to 50 years, men only
- Conditions the study is for
- Androgenetic Alopecia
- What is being tested?
- fraction laser
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteTaiwan
- Study dates
- 26 Dec 2025to 31 Oct 2027
- Phase
- Interventional
- 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 50 years
- Men only
- No healthy volunteers
- Adult
Who may be able to join
- Male pattern baldness diagnosed according to the Norwood-Hamilton classification III-V
- Males aged 18 to 50 years
- Willing to provide written informed consent and possessing the ability to read, write, speak, and understand
- Able to follow the study's treatment guidelines
Who cannot join
- Those who have taken oral Finasteride, Dutasteride, or Minoxidil within 6 months prior to the start of the trial.
- Those who have used any topical or systemic medications that may affect hair growth within 6 months prior to the start of the trial.
- Those who have received phototherapy, laser therapy, exosome therapy, or hair regrowth injections (such as minimally invasive procedures) within 6 months prior to the start of the trial.
- Those with a history of hair transplant surgery.
- Those suffering from other systemic or scalp diseases that may affect hair growth (e.g., iron deficiency anemia, immune disorders, thyroid diseases, and syphilis).
- Those with a history of severe inflammation, keloids, malignant tumors, or poor wound healing at the treatment site.
Show all 9Show fewer
- Those with other diseases that make them unsuitable for fractional laser treatment.
- Those with a history of malignant tumors or currently undergoing treatment.
- Participants must not undergo any cosmetic procedures that may affect scalp condition or hair growth throughout the entire trial period, including hair dyeing, perming, bleaching, scalp exfoliation, deep scalp cleansing, or any other actions that may irritate or damage the scalp.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Taiwan1 site, 1 recruiting
- Recruiting
Chang Gung Memorial Hospital Taoyuan branch
Taoyuan, Taoyuan, 33302
Chun-Yu Cheng, 033196200, dermatology99999@gmail.com
About this study
This trial aims to evaluate the efficacy, safety, and tolerability of fractional laser combined with topical exosome for hair regrowth in patients with androgenetic alopecia.
This study is expected to recruit 30 participants. The experimental group will receive fractional laser treatment combined with human umbilical cord mesenchymal stem cell exosome solution; the control group will receive fractional laser treatment combined with a placebo. Participants will receive three fractional laser treatments and will be followed up for 6 months. At each follow-up visit, hair density, diameter, vellus hair to terminal hair ratio, and adverse reactions will be assessed using trichotomy; a global photographic assessment will be performed using standardized imaging equipment.
- Conditions
- Androgenetic Alopecia
- Being tested
- fraction laser
- Keywords
- Androgenetic Alopecia, exosome, minoxidil, fractional laser
- Medical subject headings
- Alopecia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
fraction laserDevice
We will performed the fraction laser on the scalp of participants with energy of 30-40mJ every month for 3 times.
| Study group | Role | What they receive |
|---|---|---|
| A: left scalp: exosome/right scalp: normal saline | Other | During the first 3 months, participants received fractional laser treatment once a month. The left scalp was applied with exosome product once in the morning and once in the evening, while the right scalp was applied with normal saline once in the morning and once in the evening, with each dose being 1 ml. During the next 3 months, the left scalp was applied with the exosome product once in the morning and once in the evening, while the right scalp was applied with normal saline once in the morning and once in the evening. Receives: Device: fraction laser |
| B: right scalp: exosome/left scalp: normal saline | Other | During the first 3 months, participants received fractional laser treatment once a month. The right scalp was applied with exosome product once in the morning and once in the evening, while the left scalp was applied with normal saline once in the morning and once in the evening, with each dose being 1 ml. During the next 3 months, the right scalp was applied with the exosome product once in the morning and once in the evening, while the left scalp was applied with normal saline once in the morning and once in the evening. Receives: Device: fraction laser |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in hair density (d84)
Evaluation of the change in hair density of fractional laser combined with exosomes in improving hair growth
Measured: Baseline to Day 84
Secondary outcomes (4)
Change in hair density (d168)
Evaluation of the change in hair density of fractional laser combined with exosomes in improving hair growth.
Measured: Baseline to Day 168
Change in Hair diameter (d168)
Evaluation of the change in hair diameter of fractional laser combined with exosomes in improving hair growth.
Measured: Baseline to Day 168
Change in the percentage of vellus hair and terminal hair (d168)
Evaluation of the change in the percentage of vellus hair and terminal hair of fractional laser combined with exosomes in improving hair growth
Measured: Baseline to Day 168
Change in global photographic assessment (d168)
Evaluation of the change in global photographic assessment of fractional laser combined with exosomes in improving hair growth
Measured: Baseline to Day 168
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Nov 2025
- Study start26 Dec 2025
- Primary completion30 Sep 2027 (estimated)
- Study completion31 Oct 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- 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 N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Chang Gung Memorial Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- ExoOne bio
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07248410
- Sponsor's protocol ID
- ExoOne-CS-2025001a
- Status last verified
- Dec 2025
- First submitted
- 18 Nov 2025
- Last updated
- 22 Oct 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Suchonwanit P, Rojhirunsakool S, Khunkhet S. A randomized, investigator-blinded, controlled, split-scalp study of the efficacy and safety of a 1550-nm fractional erbium-glass laser, used in combination with topical 5% minoxidil versus 5% minoxidil alone, for the treatment of androgenetic alopecia. Lasers Med Sci. 2019 Dec;34(9):1857-1864. doi: 10.1007/s10103-019-02783-8. Epub 2019 Apr 13.
PubMed 30982177Amini F, Teh JJ, Tan CK, Tan ESS, Ng ESC. A Pilot Randomized Controlled Trial (RCT) Evaluating the Efficacy of an Exosome-Containing Plant Extract Formulation for Treating Male Alopecia. Life (Basel). 2025 Mar 20;15(3):500. doi: 10.3390/life15030500.
PubMed 40141845Chen YC, Tsai WC, Li ZX, Lin WJ, Lin HY, Hsieh YJ, Wang KH, Chen YY, Hwang TL, Lin TY. Exosomes from human umbilical cord mesenchymal stem cells promote the growth of human hair dermal papilla cells. PLoS One. 2025 Apr 30;20(4):e0320154. doi: 10.1371/journal.pone.0320154. eCollection 2025.
PubMed 40305498
Study at a glance
From the registry record, last updated by the sponsor on 22 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Split-Scalp Study Evaluating the Efficacy and Safety of Fractional Laser Therapy With and Without Exosomes in the Treatment of Androgenetic Alopecia
- ClinicalTrials.gov ID
- NCT07248410
- Acronym / sponsor ID
- ExoOne-CS-2025001a
- Conditions
- Androgenetic Alopecia
- Keywords
- Androgenetic Alopecia, exosome, minoxidil, fractional laser
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- Chang Gung Memorial HospitalUniversity, hospital or other
- Collaborators
- ExoOne bio
- Study start
- 26 Dec 2025 (actual)
- Primary completion
- 30 Sep 2027 (estimated)
- Study completion
- 31 Oct 2027 (estimated)
- First posted
- 25 Nov 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.
This trial aims to evaluate the efficacy, safety, and tolerability of fractional laser combined with topical exosome for hair regrowth in patients with androgenetic alopecia.
This study is expected to recruit 30 participants. The experimental group will receive fractional laser treatment combined with human umbilical cord mesenchymal stem cell exosome solution; the control group will receive fractional laser treatment combined with a placebo. Participants will receive three fractional laser treatments and will be followed up for 6 months. At each follow-up visit, hair density, diameter, vellus hair to terminal hair ratio, and adverse reactions will be assessed using trichotomy; a global photographic assessment will be performed using standardized imaging equipment.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| A: left scalp: exosome/right scalp: normal saline | Other | Device: fraction laserDuring the first 3 months, participants received fractional laser treatment once a month. The left scalp was applied with exosome product once in the morning and once in the evening, while the right scalp was applied with normal saline once in the morning and once in the evening, with each dose being 1 ml. During the next 3 months, the left scalp was applied with the exosome product once in the morning and once in the evening, while the right scalp was applied with normal saline once in the morning and once in the evening. |
| B: right scalp: exosome/left scalp: normal saline | Other | Device: fraction laserDuring the first 3 months, participants received fractional laser treatment once a month. The right scalp was applied with exosome product once in the morning and once in the evening, while the left scalp was applied with normal saline once in the morning and once in the evening, with each dose being 1 ml. During the next 3 months, the right scalp was applied with the exosome product once in the morning and once in the evening, while the left scalp was applied with normal saline once in the morning and once in the evening. |
Who may qualify
- Ages
- 18 to 50 years
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- Male pattern baldness diagnosed according to the Norwood-Hamilton classification III-V
- Males aged 18 to 50 years
- Willing to provide written informed consent and possessing the ability to read, write, speak, and understand
- Able to follow the study's treatment guidelines
Key exclusion criteria (9 listed)
- Those who have taken oral Finasteride, Dutasteride, or Minoxidil within 6 months prior to the start of the trial.
- Those who have used any topical or systemic medications that may affect hair growth within 6 months prior to the start of the trial.
- Those who have received phototherapy, laser therapy, exosome therapy, or hair regrowth injections (such as minimally invasive procedures) within 6 months prior to the start of the trial.
- Those with a history of hair transplant surgery.
- Those suffering from other systemic or scalp diseases that may affect hair growth (e.g., iron deficiency anemia, immune disorders, thyroid diseases, and syphilis).
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 |
|---|---|---|
| fraction laserWe will performed the fraction laser on the scalp of participants with energy of 30-40mJ every month for 3 times. | Device | A: left scalp: exosome/right scalp: normal saline, B: right scalp: exosome/left scalp: normal saline |
Primary outcome
Change in hair density (d84)
Time frame: Baseline to Day 84
Evaluation of the change in hair density of fractional laser combined with exosomes in improving hair growth
4 secondary outcomes
Change in hair density (d168)
Time frame: Baseline to Day 168
Change in Hair diameter (d168)
Time frame: Baseline to Day 168
Change in the percentage of vellus hair and terminal hair (d168)
Time frame: Baseline to Day 168
Change in global photographic assessment (d168)
Time frame: Baseline to Day 168
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 22 Oct 2026.
- Background: PubMed 30982177Suchonwanit P, Rojhirunsakool S, Khunkhet S. A randomized, investigator-blinded, controlled, split-scalp study of the efficacy and safety of a 1550-nm fractional erbium-glass laser, used in combination with topical 5% minoxidil versus 5% minoxidil alone, for the treatment of androgenetic alopecia. Lasers Med Sci. 2019 Dec;34(9):1857-1864. doi: 10.1007/s10103-019-02783-8. Epub 2019 Apr 13.
- Background: PubMed 40141845Amini F, Teh JJ, Tan CK, Tan ESS, Ng ESC. A Pilot Randomized Controlled Trial (RCT) Evaluating the Efficacy of an Exosome-Containing Plant Extract Formulation for Treating Male Alopecia. Life (Basel). 2025 Mar 20;15(3):500. doi: 10.3390/life15030500.
- Background: PubMed 40305498Chen YC, Tsai WC, Li ZX, Lin WJ, Lin HY, Hsieh YJ, Wang KH, Chen YY, Hwang TL, Lin TY. Exosomes from human umbilical cord mesenchymal stem cells promote the growth of human hair dermal papilla cells. PLoS One. 2025 Apr 30;20(4):e0320154. doi: 10.1371/journal.pone.0320154. eCollection 2025.
- Individual participant dataSharing planned: No
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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 study testing fraction laser in people with Androgenetic Alopecia, run by Chang Gung Memorial Hospital at 1 site in Taiwan.
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 4 inclusion and 9 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: looking for participants now, as of the sponsor's last update on 22 Oct 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 Taiwan. 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?
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 Chun-Yu Cheng, MD (+88633196200, dermatology99999@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in hair density (d84) (time frame: Baseline to Day 84). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07248410, which also lists 3 linked publications.
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 22 Oct 2026.