The objective of this clinical study is to assess the safety and efficacy of using a laser and hair growth factors in the treatment of male-pattern hair loss. Participating subjects will receive up to two (2) treatments per month for 6 months with the laser and post-treatment topically applied hair growth factors and will have a 6 month follow-up period.
This is a single-center, open-label, baseline-controlled, study evaluating the use of a Thulium laser (1927nm) and post-treatment topically applied KeraFactor, which contain hair-stimulating growth factors, in the treatment of androgenetic alopecia. The study may enroll up to 20 subjects looking for improvement in their hair loss. Multiple treatment areas per subject may be included. Each subject will receive up to two (2) treatments per month over a 3-month period. Follow Up Visits are planned for 3, and 9 months post last treatment. Standardized photography of the treatment 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. The follow up phase will consist of before and after photographs graded by blinded observers. Subjects are instructed to inform clinical staff after the treatment if they experience any adverse events.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
LaseMD Lutronic Laser is a 1927-nm fractionated thulium laser, which is better absorbed by water than non-ablative 1,540-nm erbium glass laser energy. The laser energy and power can be customized to target a specific penetration depth and achieve selective photothermolysis in skin while mitigating injury to surrounding tissue. The thermal energy generated by the laser has been shown to facilitate the delivery of kerafactor, which contain hair growth factors to stimulate follicular progenitor cell proliferation and differentiation into follicular keratinocytes to promote hair growth.
Montefiore Medical Center
The Bronx, New York, United States
Percentage of subjects with score of 2 or 3 on Clinician Global Aesthetic Improvement (CGAIS) scale at week 12 of treatment.
Clinician Global Aesthetic Improvement Scale (CGAIS) is a Likert scale, ranging from "greatly decreased (-3)" hair growth to "greatly increased (+3)" hair growth. 1. Greatly decreased (-3) 2. Moderately decreased (-2) 3. Slightly decreased (-1) 4. No change (0) 5. Slightly increased (+1) 6. Moderately increased (+2) 7. 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: 12 weeks
Percentage of subjects with score of 2 or 3 on Subject Global Aesthetic Improvement at week 12 of treatment.
Subject Global Aesthetic Improvement Scale (SGAIS) is a Likert scale, ranging from "greatly decreased (-3)" hair growth to "greatly increased (+3)" hair growth. 1. Greatly decreased (-3) 2. Moderately decreased (-2) 3. Slightly decreased (-1) 4. No change (0) 5. Slightly increased (+1) 6. Moderately increased (+2) 7. 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: 12 weeks
Percentage of subjects with score of 2 or 3 on Patient Satisfaction Questionnaire at week 12 of treatment.
Patient Satisfaction Questionnaire will use Lickert scale, ranging from "greatly decreased (-3)" to "greatly increased (+3)". 1. Greatly decreased (-3) 2. Moderately decreased (-2) 3. Slightly decreased (-1) 4. No change (0) 5. Slightly increased (+1) 6. Moderately increased (+2) 7. Greatly increased (+3) The seven point Lickert scale will apply to following patient satisfaction questions: 1. Please choose the option that better represents the change in how your hair looks OVERALL in the area treated? 2. Please choose the option that better represents the change in your hair THICKNESS in the area treated? 3. Please choose the option that better represents the change in your hair SHEDDING/LOSS in the area treated? 4. Please choose the option that better represents the change in your hair DARKNESS in the area treated.
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Time frame: 12 weeks
Reported pain score on Numeric Rating Scale for Pain
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 Kerafactor.
Time frame: 12 weeks