NCT03331003

"iRestore" Light Therapy Apparatus

"iRestore" Light Therapy Apparatus in the Treatment of Androgenetic Alopecia: A Randomized, Double-blind, Self-comparison, Sham Device-controlled, Multicenter Trial

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 100 (actual)
• Sponsor: National Taiwan University Hospital · Academic / Other
• Sex: All
• Age: 25 Years – 60 Years
• Healthy volunteers: Accepted

Summary

Current effective therapies of pattern hiar loss are topical minoxidil and oral finasteride. Finasteride is an inhibitor of type 2 5α-reductase and will cause hypospadias in male infant if taken or touched by pregnant woman. The effect of minoxidil is still known now but the dilation of scalp vessel might improve the progression of pattern hair oss. However, minoxidil is not effective for frontotemporal recession and sometimes cause scalp irritation. Low-level laser therapy (LLLT) a new therapy to treat alopecia. In 2007, LLLT was approved by the FDA as a treatment for hair loss. In some small studies, patients had a decrease in the number of vellus hairs, an increase in the number of terminal hairs, and an increase in shaft diameter. Up to now, however, no longer, placebo-controlled studies have proved its efficacy in this application. According to the mechanism of paradoxical hair growth (PHG), sublethal injury to the hair follicle could stimulate the hair follicle to enter anagen via the release of factors that alter angiogenesis, leading to increased blood flow to the dermal papilla. Furthermore, load inflammation in the papilla nad heat shok response, possibly mediated by HSP27, may play a role in activation of follicular stem cell. This study is a randomized, blinded, self-comparison and superior clinical trial design. In this clinical trial, the investigators try to evaluate the efficacy of low-level laser therapy in treating pattern hair loss. Pattern hair loss is characterized by increased vellus hairs and decreased shaft diameter, and these features are improved by LLLT in previous.

Detailed description

This study is A randomized, double-blind, self-comparison, sham device- controlled, multicenter Trial. Total subjects is 100 and the clinical trial was conducted in National Taiwan University Hospital and National Taiwan University Hospital-Hsinchu Branch. The study starts from December 2013 to June 2015 for within 18 months. The potential subjects will be collected into the clinical study, and have 24 weeks of treatment. The forth, twelve and twenty-fourth weeks are took as evaluation point. Besides the photo shooting area, recording the density of hair growth, analyzing of hair growth number, and the width of hair will be quantified. At the same time, the subject will also have the safety evaluation to see if there are any reddish or skin disorder(erythema, edema, dried, skin keratinization) or other systematic symptom. After quantifying the data, the degree of covered area in target area is seen as primary end point.

Conditions

• Alopecia

Interventions

Type	Name	Description
DEVICE	low level light therapy	iRestore low-level light therapy on androgenetic alopecia
DEVICE	non-LLLT wavelength group	A LED light device is non-curative for the patients.

Timeline

• Start date: 2015-03-30
• Primary completion: 2016-12-15
• Completion: 2016-12-15
• First posted: 2017-11-06
• Last updated: 2017-11-06