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"iRestore" Light Therapy Apparatus

NCT03331003 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 100

Last updated 2017-11-06

No results posted yet for this study

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.

Conditions

Interventions

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.

Sponsors & Collaborators

  • National Taiwan University Hospital Hsin-Chu Branch

    collaborator OTHER

  • National Taiwan University Hospital

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
25 Years
Max Age
60 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2015-03-30
Primary Completion
2016-12-15
Completion
2016-12-15

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Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03331003 on ClinicalTrials.gov