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

Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexMale
Age18-50
SponsorChang Gung Memorial Hospital

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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

Disqualifiers

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.

Trial design

Design model

Parallel

Treatments tested in this trial

  • fraction laser

    Device

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

Treatment groups

30 Participants
are divided into 2 treatment groups
Group A: A: left scalp: exosome/right scalp: normal salineOther 1 intervention
Group B: B: right scalp: exosome/left scalp: normal salineOther 1 intervention

Trial outcomes

Primary outcomes

1

Change in hair density (d84)

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

Time frame
Baseline to Day 84

Secondary outcomes

1

Change in hair density (d168)

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

Time frame
Baseline to Day 168
2

Change in Hair diameter (d168)

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

Time frame
Baseline to Day 168
3

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

Time frame
Baseline to Day 168
4

Change in global photographic assessment (d168)

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

Time frame
Baseline to Day 168

Other outcomes

Sponsors and contacts

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