NCT04882969

Thulium Laser and KeraFactor for the Treatment of Androgenetic Alopecia

A Pilot Study Evaluating the Safety and Efficacy of a Fractionated Thulium Laser and KeraFactor for the Treatment of Alopecia

• Status: Withdrawn
• Phase: N/A
• Study type: Interventional
• Enrollment: 0 (actual)
• Sponsor: Montefiore Medical Center · Academic / Other
• Sex: All
• Age: 18 Years – 65 Years
• Healthy volunteers: Accepted

Summary

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.

Detailed description

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.

Conditions

• Androgenetic Alopecia

Interventions

Type	Name	Description
DEVICE	Fractionated Thulium laser	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.

Timeline

• Start date: 2021-09-01
• Primary completion: 2023-06-30
• Completion: 2024-12-31
• First posted: 2021-05-12
• Last updated: 2021-08-12

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated device study