The objective of this clinical study is to compare the safety and efficacy of a laser and topically applied platelet-rich plasma vs. platelet rich plasma injection in the treatment of male-pattern hair loss. Participating subjects will receive up to four (4) monthly treatments and will have a 12 month follow-up period.
This is a single institution, open-label, baseline-controlled, prospective study evaluating the use of a non-ablative fractionated thulium laser and topical autologous platelet-rich plasma (PRP) vs. PRP injection for the treatment of male androgenetic alopecia (MAA). Given that this is a feasibility study, the investigators do provide formal sample size calculations. The findings of the study will inform that effect size associated with the treatment under study, which will inform the sample size (and power) calculations of a full, large-scale study. For this feasibility study, the investigators conservatively estimated the number of eligible patients that can reasonably enroll in the study time frame. Over the course of 1 year, the investigators typically see 50 patients with this condition annually. Of those, the investigators anticipate 25-50% would be eligible and agree to participate in the study. Given this, the investigators reasonably believe the enrollment will be 12 male subjects, ≥ 18 years of age at time of signed informed consent, of whom 6 will be randomized to receive laser + topical PRP and 6 to receive PRP injection. Follow-up visits are planned for months 7, 10, 13, and 16. Standardized photography, hair density measurement of the treated scalp areas will be recorded Pre and Post Treatment at each visit. Measurement outcomes will be compared to baseline. During the initial visit, subjects who meet the study's eligibility criteria will receive the first treatment after signing informed consent form.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
For this study, the investigators will use non-ablative fractional Thulium laser (1927 nm), provided by LaseMD, (Lutronic, Inc, USA). The non-ablative fractionated treatments with minimal downtime provide synergistic benefit of minimizing tissue damage while improving treatment tolerance and efficiency. The laser works by creating micro-channels in the dermis of the pilosebaceous unit, while leaving bridges of untouched tissue for improved permeability, faster healing, and enhanced delivery of topical treatments. The parameters of the laser will be set according to optimal operation protocol and in accordance with guidelines set forth by LaseMD. More than one affected area of the scalp may be treated per session. Each laser treatment will take approximately 10 to 15 minutes per subject. Pretreatment preparation will consist of cleaning the affected area of the scalp with antiseptic, either 70% ethanol or 3% hydrogen peroxide.
Platelet rich plasma (PRP) will be collected from participant in accordance with FDA section 21CFR640.34 regulation on collection and preparation of PRP. The collected blood will be processed according to manufacturer protocol to obtain PRP, which will be injected with a syringe and needle subcutaneously into the participant's scalp.
Percentage of subjects with score of 2 or 3 on Clinician Global Aesthetic Improvement (CGAIS) scale at month 7 follow-up.
Clinician Global Aesthetic Improvement Scale (CGAIS) is a Likert scale, ranging from "greatly decreased (-3)" hair growth to "greatly increased (+3)" hair growth. Greatly decreased (-3) Moderately decreased (-2) Slightly decreased (-1) No change (0) Slightly increased (+1) Moderately increased (+2) Greatly increased (+3) Based on a live assessment of the subject while referring to the subject's pre-treatment scalp photographs, the clinician will make an assessment of post-treatment hair growth.
Time frame: 7 months
Percentage of subjects with score of 2 or 3 on Subject Global Aesthetic Improvement at month 7 follow-up.
Subject Global Aesthetic Improvement Scale (SGAIS) is a Likert scale, ranging from "greatly decreased (-3)" hair growth to "greatly increased (+3)" hair growth. Greatly decreased (-3) Moderately decreased (-2) Slightly decreased (-1) No change (0) Slightly increased (+1) Moderately increased (+2) Greatly increased (+3) Subjects will be given a hand mirror for self-assessment of post-treatment hair growth compared to subject's pre-treatment scalp photographs.
Time frame: 7 months
Percentage of subjects with score of 2 or 3 on Patient Satisfaction Questionnaire at month 7 follow-up.
Patient Satisfaction Questionnaire will use Lickert scale, ranging from "greatly decreased (-3)" to "greatly increased (+3)". Greatly decreased (-3) Moderately decreased (-2) Slightly decreased (-1) No change (0) Slightly increased (+1) Moderately increased (+2) Greatly increased (+3) The seven point Lickert scale will apply to following patient satisfaction questions: Please choose the option that better represents the change in how your hair looks OVERALL in the area treated? Please choose the option that better represents the change in your hair THICKNESS in the area treated? Please choose the option that better represents the change in your hair SHEDDING/LOSS in the area treated? Please choose the option that better represents the change in your hair DARKNESS in the area treated.
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Platelet rich plasma (PRP) will be collected from participant in accordance with FDA section 21CFR640.34 regulation on collection and preparation of PRP. The collected blood will be processed according to manufacturer protocol to obtain PRP, which will be applied topically with a syringe to one or more affected areas on the participant's scalp that were previously treated with thulium laser.
Time frame: 7 months
Reported pain score on Numeric Rating Scale for Pain for first 4 months during treatment
The Numeric Rating Scale for Pain is an 11-point scale scored from 0-10, with 0 = no pain, 5 = moderate pain, and 10 = worst possible pain. Subjects select a value that is most in line with the intensity of their pain experienced during and after treatment with Thulium Laser and topical platelet rich plasma or platelet rich plasma injection. The NRS pain questionnaire will be given to participants to complete for each treatment for the first 4 months of the study.
Time frame: 4 months