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

NCT ID: NCT07248410

Last Updated: 2025-11-25

Basic Information

• Recruitment Status: NOT_YET_RECRUITING
• Clinical Phase: NA
• Total Enrollment: 30 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2025-11-24
• Study Completion Date: 2027-10-31

Brief 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. 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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: TRIPLE

Study Groups

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

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.

Group Type: OTHER

fraction laser

Intervention Type: DEVICE

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

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

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.

Group Type: OTHER

fraction laser

Intervention Type: DEVICE

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

Interventions

fraction laser

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

Intervention Type: DEVICE

Eligibility Criteria

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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 50 Years
• Eligible Sex: MALE
• Accepts Healthy Volunteers: No

Sponsors

ExoOne bio

UNKNOWN

Sponsor Role: collaborator

Chang Gung Memorial Hospital

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Chang Gung Memorial Hospital Taoyuan branch

Taoyuan District, Taoyuan, Taiwan

Countries

Taiwan

Central Contacts

Chun-Yu Cheng, MD

Role: CONTACT

dermatology99999@gmail.com

+88633196200

Facility Contacts

Chun-Yu Cheng

Role: primary

dermatology99999@gmail.com

033196200

References

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.

Reference Type: BACKGROUND

PMID: 30982177 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 40141845 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 40305498 (View on PubMed)

Other Identifiers

ExoOne-CS-2025001a

Identifier Type: -

Identifier Source: org_study_id