"iRestore" Light Therapy Apparatus
キーワード
概要
説明
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.
日付
最終確認済み: | 02/28/2014 |
最初に提出された: | 10/17/2017 |
提出された推定登録数: | 10/30/2017 |
最初の投稿: | 11/05/2017 |
最終更新が送信されました: | 10/30/2017 |
最終更新日: | 11/05/2017 |
実際の研究開始日: | 03/29/2015 |
一次完了予定日: | 12/14/2016 |
研究完了予定日: | 12/14/2016 |
状態または病気
介入/治療
Device: low level light therapy
Device: non-LLLT wavelength group group
段階
アームグループ
腕 | 介入/治療 |
---|---|
Experimental: low level light therapy 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 iRestore low-level light therapy on androgenetic alopecia |
Placebo Comparator: non-LLLT wavelength group group 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 group A LED light device is non-curative for the patients. |
適格基準
研究の対象となる年齢 | 25 Years に 25 Years |
研究に適格な性別 | All |
健康なボランティアを受け入れる | はい |
基準 | Inclusion Criteria: 1. The subjects of either gender who are 25-60 years old. 2. The male-pattern alopecia in men belongs to Stages IIa-V of the Norwood-Hamilton Scale; 3. The male-pattern alopecia in women belongs to Stages I-4, II-1 and II-2 of the Ludwig (Savin) Scale. 4. The subjects shall agree to have temporary punctate tattoo at the observed part. 5. There was continuous hair loss during the past 12 months. 6. Women with fertility shall agree to adopt appropriate contraception measures, including the intrauterine device, condom, spermicide, abstinence, vasoligation of the sexual partner, etc. 7. The skin type ranges between Types I and IV of Fitzpatrick scale, as shown in Table 1. 8. The subjects agree to shave off the hair at the observed part. 9. The photographic release form shall be read carefully before the signature. 10. 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 Criteria: 1. 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. 2. 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. 3. Patients with Type 2 diabetes. 4. Patients with heart disease who take phototoxic drugs. 5. Those who don't agree to maintain the hairstyle and hair color during the trial. 6. 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. 7. 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. 8. There is psoriasis, dermatitis, eczema or severe acne on the scalp. 9. 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. 10. Those with insignificant contrast of scalp and hair color, such as light skin color or white hair. 11. 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. |
結果
主な結果の測定
1. Hair coverage of the targeted area [In the 24th week]
二次的な結果の測定
1. evaluate the hair coverage [in the 4th and 12th weeks]
2. evaluate the increased hair thickness of the targeted area [in the 4th, 12th and 24th weeks]
3. number of the hair in the targeted area [in the 4th, 12th and 24th weeks]
4. global assessment of the hair growth condition [in the 4th, 12th and 24th weeks]
5. global assessment of the hair growth condition [in the 4th, 12th and 24th weeks]
6. global assessment of the hair growth condition [in the 4th, 12th and 24th weeks]
7. global assessment of the hair growth condition [in the 4th, 12th and 24th weeks]
8. The subjects' overall satisfaction assessment [in the 4th, 12th and 24th weeks]
9. The subjects' overall satisfaction assessment [in the 4th, 12th and 24th weeks]
10. The subjects' overall satisfaction assessment [in the 4th, 12th and 24th weeks]
11. The subjects' overall satisfaction assessment [in the 4th, 12th and 24th weeks]
12. The subjects' overall satisfaction assessment [in the 4th, 12th and 24th weeks]