Clinical trial NCT05129254: Thulium Laser and Topical Platelet Rich Plasma (PRP) vs. PRP Injection for the Treatment of Male Androgenetic Alopecia
Official title: A Pilot Study Evaluating the Safety and Efficacy of a Fractionated Thulium Laser and Topical Platelet Rich Plasma vs. Platelet Rich Plasma Injection for the Treatment of Male Androgenetic Alopecia
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: NA
Conditions: Androgenetic Alopecia
Keywords: alopecia
laser
platelet rich plasma
male pattern hair loss
Lead sponsor: Montefiore Medical Center
Sponsor class: OTHER
First posted: 2021-11-22
Enrollment: 0
Sex: MALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: To compare the efficacy of laser to improve delivery of topical platelet rich plasma (PRP) to promote hair growth, the investigators will employ a randomized, unblinded, baseline-controlled study design. There will be two parallel treatment arms in the study. The first arm will enroll six participants to receive thulium laser and topical PRP. The second arm will enroll six participants to receive PRP injection alone. Total participants enrolled will be twelve (12). There will be a total of 8 study visits (4 treatment and 4 follow-up) lasting 16 months.

Each participant will receive an initial series of 4 treatments, either laser + topical PRP or PRP injection alone once a month for the first 4 months (month 1, 2, 3, 4). Thereafter, patients will be followed at 3-month intervals at month 7, 10, 13, and 16.
Primary purpose: TREATMENT

Brief summary: 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.

Detailed description: 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.

Eligibility criteria: Inclusion Criteria:

* Healthy male, ≥ 18 years of age at time of informed consent, seeking treatment for hair loss.
* Subject must voluntarily sign and date an IRB approved informed consent form
* Subjects with diagnosis of androgenetic alopecia with hair loss recorded over the past 6 months. (Norwood Hamilton Class 3-4 for males)
* Able to read, understand and voluntarily provide written informed consent.
* Subject is determined to be healthy, non-smoker who agrees not to make any changes to their daily hair treatment regime during the study.
* Subjects able and willing to comply with the treatment protocol and follow-up schedule and requirements.
* Understands and accepts the obligation not to undergo any other procedures in the areas to be treated through the follow-up period.

Exclusion Criteria:

* Subjects does not have the capacity to consent to the study
* Subject has other types of alopecia of the scalp (i.g., alopecia areata, scarring alopecia)
* Use of minoxidil or 5-alpha reductase inhibitors (i.e., finasteride, dutasteride) 3 months prior to screening date.
* Any medical condition that in the consideration of the investigator, would present an increased risk of a photosensitivity reaction to the subject.
* Any previous surgical procedure in the treatment area in the past 12 months, or major surgery in the last 6 months.
* History of immunosuppression/immune deficiency disorders (including AIDS and HIV infection), and/or any history of systemic chemotherapy for prior 12 months.
* History or current use of the following prescription medications:

  i. Immunosuppressive medications/biologics, 6 months prior to and during the study ii. Accutane or other systemic retinoids within the past twelve months
* Smoking or vaping in the past 12 months.
* History of hyperlipidemia, diabetes mellitus, hepatitis, or bleeding disorders.
* History of major depressive disorders or endocrine disorders including but not limited to; hypothyroidism, Hashimoto's thyroiditis, or hyperthyroidism.

Primary outcomes:
measure: Percentage of subjects with score of 2 or 3 on Clinician Global Aesthetic Improvement (CGAIS) scale at month 7 follow-up.
timeFrame: 7 months
measure: Percentage of subjects with score of 2 or 3 on Subject Global Aesthetic Improvement at month 7 follow-up.
timeFrame: 7 months
Secondary outcomes:
measure: Percentage of subjects with score of 2 or 3 on Patient Satisfaction Questionnaire at month 7 follow-up.
timeFrame: 7 months
measure: Reported pain score on Numeric Rating Scale for Pain for first 4 months during treatment
timeFrame: 4 months
Other outcomes:
Locations:
Study officials:
affiliation: Montefiore Medical Center
name: Kseniya Kobets, MD
role: PRINCIPAL_INVESTIGATOR
References: