"iRestore" Light Therapy Apparatus

NCT03331003 | Completed

• 1 other identifier: 201310067DSB
• Study Type: interventional
• Target: 100
• Locations: 0 countries
• Sites: N/A

Brief 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

Alopecia

Outcome Measures

Primary Outcomes (1)

• Hair coverage of the targeted area

  The photomicrography is taken to record the hair growth in the target area. The Folliscope (IBS-01 Pro Beauty Scope, Kowa Optics Corp.) is used to record the hair coverage in the tattooed area and analyze the hair growth number. The photography of the global scalp is also taken to record the top scalp and hair line shapes of the subjects. Hair coverage equals to ∑\_(i=1)\^n\*π R\_i\^2

  In the 24th week

Secondary Outcomes (12)

• evaluate the hair coverage

  in the 4th and 12th weeks

• evaluate the increased hair thickness of the targeted area

  in the 4th, 12th and 24th weeks

• number of the hair in the targeted area

  in the 4th, 12th and 24th weeks

• global assessment of the hair growth condition

  in the 4th, 12th and 24th weeks

• global assessment of the hair growth condition

  in the 4th, 12th and 24th weeks

Study Arms (2)

low level light therapy

EXPERIMENTAL

1 group uses the investigational device on the left side, and the subjects will have half part receiving low level light therapy (red light-emitting diode and laser irradiation)

Device: low level light therapy

non-LLLT wavelength group group

PLACEBO COMPARATOR

the control device on the right side, other half with non-low-level laser therapy wavelength (white light-emitting diode light bulb coating with red paint to make the irradiating light close to the red).

Device: non-LLLT wavelength group

Interventions

low level light therapy DEVICE

iRestore low-level light therapy on androgenetic alopecia

low level light therapy

non-LLLT wavelength group DEVICE

A LED light device is non-curative for the patients.

non-LLLT wavelength group group

Eligibility Criteria

• Age: 25 Years - 60 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• The subjects of either gender who are 25-60 years old.
• The male-pattern alopecia in men belongs to Stages IIa-V of the Norwood-Hamilton Scale;
• The male-pattern alopecia in women belongs to Stages I-4, II-1 and II-2 of the Ludwig (Savin) Scale.
• The subjects shall agree to have temporary punctate tattoo at the observed part.
• There was continuous hair loss during the past 12 months.
• Women with fertility shall agree to adopt appropriate contraception measures, including the intrauterine device, condom, spermicide, abstinence, vasoligation of the sexual partner, etc.
• The skin type ranges between Types I and IV of Fitzpatrick scale, as shown in Table 1.
• The subjects agree to shave off the hair at the observed part.
• The photographic release form shall be read carefully before the signature.
• The informed consent form shall be read carefully to understand the detailed trial content and the signature shall be made without any disturbance.
• Table 1. Fitzpatrick Skin Typing
• Always burns, never tans
• Usually burns, tans minimally
• Frequently burns and tans (light brown)
• Rarely burns, tans easily (brown)

You may not qualify if:

• Use or administration of the following drugs within 6 months before the recruitment:
• Minoxidil, finasteride or other inhibitors of 5α-reductase;
• The drugs that may inhibit androgen, such as cyproterone, spironolactone, ketoconazole, flutamide and bicalutamide.
• The drugs that may cause hirsutism, such as ciclosporin, diazoxide, phenytoin, Propecia, Dutasteride and psoralens, or other drugs for treating prostatic hypertrophy.
• Oral adrenal corticoid (except inhaler adrenal corticoid)
• The drugs with possible phototoxicity, such as tetracyclins, thiazides and certain NSAIDS.
• Lithium or antischizophrenic drugs (phenothiazines);
• Any drugs that will influence the assessment results or subjects' safety according to the opinions of the principal investigator.
• Anti-cancer drugs.
• Pregnant or breastfeeding women or those plan to get pregnant during the trial. The women with fertility shall take the contraceptive drugs orally or have the implantation, injection or subcutaneous injection of contraceptive drugs.
• Patients with Type 2 diabetes.
• Patients with heart disease who take phototoxic drugs.
• Those who don't agree to maintain the hairstyle and hair color during the trial.
• Those who had hair transplantation, scalp reconstruction procedure, hair braiding or scalp tattoo, which will influence the assessment results of the test or the subjects' safety according to the opinions of the principal investigator.
• Those who use or once used depilation agents, laser hair removal or beeswax on the scalp to remove the hair or perform any action which will influence the assessment results of the trial according to the opinions of the principal investigator.

Sponsors & Collaborators

• National Taiwan University Hospital: lead
• National Taiwan University Hospital Hsin-Chu Branch: collaborator

MeSH Terms

Conditions

Alopecia

Interventions

Low-Level Light Therapy

Condition Hierarchy (Ancestors)

Hypotrichosis; Hair Diseases; Skin Diseases; Skin and Connective Tissue Diseases; Pathological Conditions, Anatomical; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Laser Therapy; Therapeutics; Phototherapy

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 18, 2017
• First Posted: November 6, 2017
• Study Start: March 30, 2015
• Primary Completion: December 15, 2016
• Study Completion: December 15, 2016
• Last Updated: November 6, 2017

Record last verified: 2014-03