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

Chang Gung Medical Foundation

Status: Not yet enrolling

Conditions: Androgenetic Alopecia

Treatments: Device: fraction laser

Study type: Interventional

Funder types: Other

Identifiers

NCT07248410

ExoOne-CS-2025001a

Details and patient eligibility

About

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.

Enrollment: 30 estimated patients

Sex: Male

Ages: 18 to 50 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

1. Male pattern baldness diagnosed according to the Norwood-Hamilton classification III-V
2. Males aged 18 to 50 years
3. Willing to provide written informed consent and possessing the ability to read, write, speak, and understand
4. Able to follow the study's treatment guidelines

Exclusion criteria

1. Those who have taken oral Finasteride, Dutasteride, or Minoxidil within 6 months prior to the start of the trial.
2. Those who have used any topical or systemic medications that may affect hair growth within 6 months prior to the start of the trial.
3. 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.
4. Those with a history of hair transplant surgery.
5. Those suffering from other systemic or scalp diseases that may affect hair growth (e.g., iron deficiency anemia, immune disorders, thyroid diseases, and syphilis).
6. Those with a history of severe inflammation, keloids, malignant tumors, or poor wound healing at the treatment site.
7. Those with other diseases that make them unsuitable for fractional laser treatment.
8. Those with a history of malignant tumors or currently undergoing treatment.
9. 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 design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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30 participants in 2 patient groups

A: left scalp: exosome/right scalp: normal saline

Other group

Description:

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.

Treatment:

Device: fraction laser

B: right scalp: exosome/left scalp: normal saline

Other group

Description:

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.

Treatment:

Device: fraction laser