"iRestore" Light Therapy Apparatus

Status Completed

Clinical Trial 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.

Clinical Trial 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. ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details

NCT number	NCT03331003
Study type	Interventional
Source	National Taiwan University Hospital
Contact
Status	Completed
Phase	N/A
Start date	March 30, 2015
Completion date	December 15, 2016

View Details

See also
Status	Clinical Trial	Phase
Active, not recruiting	`NCT04953416` - Fractional Non-ablative Laser for the Treatment of Hair Loss	N/A
Completed	`NCT01929330` - Bioequivalence Study of Dutasteride Five 0.1 mg and One 0.5 mg Soft Gelatin Capsules in Healthy Male Volunteers	Phase 1
Recruiting	`NCT05213936` - Scalp Cooling for Chemotherapy-Induced Alopecia in Patients of Color	N/A
Completed	`NCT02919735` - Efficacy, Safety and Tolerability of CG428 Cutaneous Solution on Chemotherapy Induced Alopecia; Controlled Study (ELAN)	Phase 2
Recruiting	`NCT02591823` - Hair Fall in Patients on Low Dose Methotrexate	N/A
Enrolling by invitation	`NCT01651689` - Hair Counts From Vertical and Horizontal Sections of Scalp Biopsy SPecimens in Thai Population With Alopecia	N/A
Completed	`NCT01189279` - Safety and Pharmacokinetics Study of New Formulation of Bimatoprost in Patients With Alopecia	Phase 1
Recruiting	`NCT01111981` - Safety and Efficacy of Clobetasol Propionate 0.05% E Foam in Alopecia	Phase 4
Terminated	`NCT01385839` - Efficacy of Hair Transplantation Compared With Hypodermic Needle Irritation in Alopecia Areata	N/A
Active, not recruiting	`NCT03382184` - Fractional Photothermolysis for Hair Follicle Induction	Early Phase 1
Not yet recruiting	`NCT05544448` - In Vitro Effect Study of Interleukin-2 Muteins on Regulatory T Cells of Patients With Different Autoimmune, Allo-immune or Inflammatory Diseases	N/A
Completed	`NCT03689452` - The Effect of Platelet Rich Plasma on Non-scarring Alopecia	N/A
Completed	`NCT06409650` - To Evaluate Safety and Efficacy of KX-826 in Chinese Female Subjects With Androgenetic Alopecia	Phase 2
Recruiting	`NCT00801086` - Efficacy Study of Tempol to Prevent Hair Loss From Radiotherapy to the Brain	Phase 2
Completed	`NCT06095739` - Study to Investigate the Effectiveness of a Topical Cosmetic Formulation DA-OTC-002	N/A
Completed	`NCT05587699` - The Parallel Study to Evaluate the Pharmacokinetics, Pharmacodynamics, and Safety of CKD-843 A	Phase 1
Completed	`NCT03351322` - ENERGI-F701 for Female Hair Loss Treatment	Phase 2
Not yet recruiting	`NCT01557491` - Hair Regrowth After Bicoronal Incision	N/A
Completed	`NCT01590238` - Enhancing Hair Density With Platelet Rich Fibrin Matrix (PRFM)	Phase 3
Terminated	`NCT02935569` - Compression Headband Use to Prevent Hair Loss During Whole Brain Radiotherapy	N/A