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
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Androgenetic Alopecia
- Sponsor
- Montefiore Medical Center
- Primary Endpoint
- Percentage of subjects with score of 2 or 3 on Clinician Global Aesthetic Improvement (CGAIS) scale at month 7 follow-up.
- Status
- Withdrawn
- Last Updated
- 3 years ago
Overview
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.
Investigators
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.
Outcomes
Primary Outcomes
Percentage of subjects with score of 2 or 3 on Clinician Global Aesthetic Improvement (CGAIS) scale at month 7 follow-up.
Time Frame: 7 months
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.
Percentage of subjects with score of 2 or 3 on Subject Global Aesthetic Improvement at month 7 follow-up.
Time Frame: 7 months
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.
Secondary Outcomes
- Percentage of subjects with score of 2 or 3 on Patient Satisfaction Questionnaire at month 7 follow-up.(7 months)
- Reported pain score on Numeric Rating Scale for Pain for first 4 months during treatment(4 months)