Status:
COMPLETED
"iRestore" Light Therapy Apparatus
Lead Sponsor:
National Taiwan University Hospital
Collaborating Sponsors:
National Taiwan University Hospital Hsin-Chu Branch
Conditions:
Alopecia
Eligibility:
All Genders
25-60 years
Phase:
NA
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 to...
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...
Eligibility Criteria
Inclusion
- 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)
- Very rarely burns, tans very easily (brown)
- Never burns (dark brown to black)
Exclusion
- 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.
- There is psoriasis, dermatitis, eczema or severe acne on the scalp.
- Those who suffer from the diseases which may influence the hair growth according to the opinions of the principal investigator, such as the immunodeficiency syndrome, connective tissue-related diseases or infectious baldness.
- Those with insignificant contrast of scalp and hair color, such as light skin color or white hair.
- Inability to cooperate with the trial: those subjects who can't use the device or pay a return visit periodically according to the instruction of the physician or hospital during the trial in the opinions of the principal investigator.
Key Trial Info
Start Date :
March 30 2015
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 15 2016
Estimated Enrollment :
100 Patients enrolled
Trial Details
Trial ID
NCT03331003
Start Date
March 30 2015
End Date
December 15 2016
Last Update
November 6 2017
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