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NCT Number: NCT07248410

A Split-Scalp Study Evaluating the Efficacy and Safety of Fractional Laser Therapy With and Without Exosomes in the Treatment of Androgenetic Alopecia

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.

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Key information

Age range

18 year–50 year

Sex eligibility

Male

Study type

Interventional

Phase

Not applicable

Primary location

Chang Gung Memorial Hospital Taoyuan branch

Taoyuan, 33302, Taiwan

Location contact

Chun-Yu Cheng

CONTACT

[email protected]

033196200

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

fraction laser

Device

We will performed the fraction laser on the scalp of participants with energy of 30-40mJ every month for 3 times.

Primary outcomes

  1. 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

Secondary outcomes

  1. Change in hair density (d168)

    Time frame: Baseline to Day 168

    Evaluation of the change in hair density of fractional laser combined with exosomes in improving hair growth.

  2. Change in Hair diameter (d168)

    Time frame: Baseline to Day 168

    Evaluation of the change in hair diameter of fractional laser combined with exosomes in improving hair growth.

  3. Change in the percentage of vellus hair and terminal hair (d168)

    Time frame: Baseline to Day 168

    Evaluation of the change in the percentage of vellus hair and terminal hair of fractional laser combined with exosomes in improving hair growth

  4. Change in global photographic assessment (d168)

    Time frame: Baseline to Day 168

    Evaluation of the change in global photographic assessment of fractional laser combined with exosomes in improving hair growth

Study contacts

Contact information is provided by the study sponsor or research team.

Chun-Yu Cheng, MD

CONTACT

[email protected]

+88633196200

Sponsors and collaborators

Lead sponsor

Chang Gung Memorial Hospital

Other

Collaborators

  • ExoOne bio

Registry information

Important dates

Study start
2025
Primary completion
2027
Study completion
2027
First posted
Nov 25, 2025
Registry last updated
Nov 25, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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