"iRestore" Light Therapy Apparatus
Condition: Alopecia
MeSH terms: Alopecia; Alopecia Areata
Study type: Interventional

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.
    

Intervention name(s): low level light therapy; non-LLLT wavelength group
Intervention type(s): Device; Device
Intervention description(s): iRestore low-level light therapy on androgenetic alopecia; A LED light device is non-curative for the patients.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Investigator)
Primary purpose: Treatment