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 volunteersQualifiers
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
Parallel
Treatments tested in this trial
fraction laser
DeviceWe will performed the fraction laser on the scalp of participants with energy of 30-40mJ every month for 3 times.
Treatment groups
Trial outcomes
Primary outcomes
Change in hair density (d84)
Evaluation of the change in hair density of fractional laser combined with exosomes in improving hair growth
Secondary outcomes
Change in hair density (d168)
Evaluation of the change in hair density of fractional laser combined with exosomes in improving hair growth.
Change in Hair diameter (d168)
Evaluation of the change in hair diameter of fractional laser combined with exosomes in improving hair growth.
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
Change in global photographic assessment (d168)
Evaluation of the change in global photographic assessment of fractional laser combined with exosomes in improving hair growth
Sponsors and contacts
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Chang Gung Memorial Hospital
Lead sponsor
ExoOne bio
Collaborator
This trial is not recruiting at the moment. You can still explore other options: