A Split-Scalp Study Evaluating the Efficacy and Safety of Fractional Laser Therapy With and Without Exosomes in the Treatment of Androgenetic Alopecia
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: fraction laser.
- Who it may be relevant to
- Registry conditions: Androgenetic Alopecia. Basic parameters: 18 years — 50 years · Male.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Taiwan
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Overview
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.
Interventions
- Device fraction laser
We will performed the fraction laser on the scalp of participants with energy of 30-40mJ every month for 3 times.
Primary outcome measures
- Change in hair density (d84) [Time frame: Baseline to Day 84]
Secondary outcome measures (4)
- 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]
Eligibility criteria
Inclusion criteria
- 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
Exclusion criteria
- 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.
- 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.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Triple blind
- Primary purpose
- Treatment
Study locations
Taiwan · 1 center
- Chang Gung Memorial Hospital Taoyuan branch — Taoyuan
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. PMID 30982177
- Amini 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. PMID 40141845
- Chen 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. PMID 40305498
Identifiers
NCT: NCT07248410 · ExoOne-CS-2025001a