Ignite Creation Date:
2025-12-24 @ 11:14 PM
Ignite Modification Date:
2025-12-25 @ 8:49 PM
Study NCT ID:
NCT04882969
Status:
WITHDRAWN
Last Update Posted:
2021-08-12
First Post:
2021-05-06
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Thulium Laser and KeraFactor for the Treatment of Androgenetic Alopecia
Sponsor:
Montefiore Medical Center
Organization:
Study Overview
Official Title:
A Pilot Study Evaluating the Safety and Efficacy of a Fractionated Thulium Laser and KeraFactor for the Treatment of Alopecia
Status:
WITHDRAWN
Status Verified Date:
2021-08
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Changed Indication
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief 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.
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 Oversight
Has Oversight DMC:
True
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
True
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
False
Is an FDA AA801 Violation?: