A Prospective, Randomized, Controlled, Double-Blind Study That Evaluates the Safety and Efficacy of Three Active REVIAN Caps Versus a Non-Active REVIAN Cap (Sham) in Participants With Pattern Hair Loss (Androgenic Alopecia)
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 160
- 试验地点
- 4
- 主要终点
- Mean Change in Terminal Hair Count From Baseline to 16 Weeks
研究概览
简要总结
The REVIAN study is designed as a prospective, randomized, controlled, double-blind, parallel study to evaluate the efficacy and safety of the REVIAN System in male participants with androgenic alopecia. An Active modulated light therapy REVIAN System will be compared to a Placebo Comparator non-active REVIAN System in participants using the device for a daily 10-minute treatment over the course of 26-weeks. At each follow-up visit, participants will be interviewed to determine if any adverse events (AEs) were experienced since the previous follow-up visit. All participants will be required to complete self-administering scalp hair growth and life quality questionnaires at each follow-up visit. Investigators will be required to complete global assessments of scalp hair growth for each enrolled participant at each follow-up visit. Macrophotography evaluations will be performed at baseline, 8-, 16-, and 26 weeks for all participants using standard Canfield blinded reviewer. Global photographs of superior and vertex scalp will be taken by participants and by PI to be assessed by a blinded reviewer once all photos have been captured for each participant per visit.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Triple (Participant, Care Provider, Outcomes Assessor)
盲法说明
The allocation was concealed by numbered device containers and is distributed by unblinded study administrators who are not involved with the interview of participants for study eligibility.
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •The study population will consist of adult men and women between 18 and 65 years of age with diagnosis of Androgenic Alopecia, consistent with males who have Norwood Hamilton Classification IIa to V patterns of hair loss and females who have Ludwig-Savin Scale I-1 to I-4, II -1, II-2 or frontal, both with Fitzpatrick Skin Types I - IV. Participants agree to undergo all study procedures including global photographs of hair loss/growth, placement of a 1 mm tattoo dot placed on the scalp for macrophotography, refrain from using all other hair growth products or treatments (oral or topical medication including over the counter herbal medications, or Dutasteride), avoid the use of wigs, hairpieces, and/or hair extensions during the study, return for all the required follow-up visits, and in the opinion of the Clinical Investigator, are able to understand this clinical investigation and cooperate with the investigational procedures.
- •Candidates for this study must meet ALL of the following criteria:
- •Male and Female participants between 18 and 65 years of age
- •Must be able to read and speak English.
- •Participants who are able to give voluntary, written informed consent to participate in this clinical investigation and from whom consent has been obtained.
- •Participants, who, in the opinion of the Clinical Investigator, are able to understand this clinical investigation, cooperate with the investigational procedures and are willing to return for all the required follow-up visits.
- •Participant must be able to visit clinic site at 8-, 16- and 26-weeks study visits and be available by phone at 4 weeks.
- •Participant must have the ability to communicate effectively with study personnel in person or over the phone.
- •Participant must have diagnosis of Androgenic Alopecia (pattern hair loss).
- •Participant must have active hair loss consistent with Grades IIa to V, based on Norwood- Hamilton Scale or Ludwig-Savin Scale I-1 to I-4, II -1, II-2 or frontal and Grades I - IV using Fitzpatrick Skin Type Scale.
- •Participant's hair must be at least 1 inch in length. The hair style and length shall be the same for each follow-up visit. Participants will be instructed to not have their hair cut/styled within 5 days prior to a follow-up visit.
- •Participant is willing to have a dot tattoo placed on or around the target area of the scalp.
- •Participant is willing to undergo all study procedures including consent for global photographs of hair loss/growth and a 1 mm tattoo to mark the macrophotography site along the indicated transition area of the scalp between the hairline and the balding/thinning vertex area.
- •Participant is willing to avoid the use of wigs, hairpieces, and/or hair extensions during the study period.
- •Hair Specific Skindex-29 Quality of Life total overall score of ≥
- •Participant is willing to maintain their natural hair colour or including the use of coloring throughout the study period.
- •Participant agrees to refrain from using all other hair growth products or treatments (oral or topical medication including over the counter herbal medications, or Dutasteride) during the study period.
- •Participant has the ability to utilize a Bluetooth device and application on a smart device connected to Wi-Fi.
排除标准
- •Participants with 12 month history of taking Propecia or any other hair growth supplements including Rogaine or Minoxidil based products for 6-months prior to enrollment, having previous hair transplant, cell treatment, micro-needling, tattooing, or any other treatment to the scalp, suffering from an active autoimmune disease such as serum lupus erythematosus or alopecia areata, photosensitivity to visible light, currently suffering from a dermatological condition in the treatment area or has a significant scar in the hair treatment area that will make hair growth difficult (such as a systemic burn, malignancy, etc.), has a sensitivity or allergy to tattoo ink, using any medication deemed to inhibit hair growth as determined by the physician investigator, or have had radiation or chemotherapy in the last 12 months will be excluded.
- •Candidates will be excluded from the study if ANY of the following apply:
- •Female participants of childbearing potential who are not on some form of birth control and do not have a confirmed negative pregnancy test at baseline
- •Use of Propecia or any other hair growth supplements within 12 months prior to enrollment.
- •Use of Rogaine or Minoxidil based products within 6 months prior to enrollment.
- •Participants have a previous hair transplant, cell treatment, micro needling, tattooing, or any other treatment to the scalp.
- •Participant is suffering from an active autoimmune disease such as lupus erythematosus (systemic and cutaneous) or alopecia areata.
- •Photosensitivity to visible light operating within 400 - 850 nm or taking medication that REVIAN® Trial Confidential and Proprietary Page 23 of 55 Version 6.0 2018-08-22 increases photosensitivity.
- •Currently suffering from a dermatological condition in the treatment area or has a significant scar in the hair treatment area that, in the opinion of the investigator, will make hair growth difficult (such as a systemic burn, malignancy, etc.)
- •Participant has a sensitivity or allergy to tattoo ink.
- •Using any medication deemed to inhibit hair growth as determined by the physician investigator.
- •Employed by the sponsor, clinic site, or entity associated with the conduct of the study.
- •Has had radiation or chemotherapy in the last 12 months.
- •Have any condition or situation which, in the Investigator's opinion, puts the participant at significant risk, could confound the study results, or may interfere significantly with the participant's participation in the study.
- •Known prior inability to complete required study visits during treatment period;
- •Use of any other investigational drug, therapy, or device within the past 30 days of enrollment or concurrent participation in another research study;
- •Are unable to communicate or cooperate with the Investigator due to language problems, poor mental development, or impaired cerebral function;
- •Participants who are currently involved in any investigational drug or device trial or have been enrolled in such trials within the last 3 months.
研究组 & 干预措施
Non-Active REVIAN (Sham) Cap 100
Sham (Control) Group
干预措施: REVIAN 100 (Device)
Active REVIAN Cap 101
(625 nm and 660 nm)
干预措施: REVIAN 101 (Device)
Active REVIAN Cap 102
(425 nm)
干预措施: REVIAN 102 (Device)
Active REVIAN Cap 103
(425 nm, 625 nm and 660 nm)
干预措施: REVIAN 103 (Device)
结局指标
主要结局
Mean Change in Terminal Hair Count From Baseline to 16 Weeks
时间窗: Primary efficacy endpoint is 16-weeks follow-up from the initial application at baseline
The primary efficacy outcome of this study is mean change in hair count from baseline. Standardized Canfield macro-photographs will be taken to capture digital images at baseline and will be compared to images captured at various endpoints throughout the study. Multiple images will be taken at each endpoint and will be reviewed by independent blinded observers to conduct the hair count
次要结局
未报告次要终点