Clinical Trials Logo

Clinical Trial Details — Status: Active, not recruiting

Administrative data

NCT number NCT04953416
Other study ID # LUM-ABU-M22-ResurFX-19-01
Secondary ID
Status Active, not recruiting
Phase N/A
First received
Last updated
Start date September 8, 2020
Est. completion date March 2022

Study information

Verified date July 2021
Source Lumenis Ltd.
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

This is a single center, prospective, open label clinical trial with before-after study design. The study is designed to evaluate the feasibility of hair growth in female and male pattern hair loss (androgenic alopecia, telogen effluvium, and alopecia areata) using a fractional non-ablative 1565nm ResurFX module.


Description:

This is a single center, prospective, open label clinical trial with before-after study design. The study is designed to evaluate the feasibility of hair growth in female and male pattern hair loss (androgenic alopecia, alopecia areata) using a fractional non-ablative 1565nm ResurFX module. This study will include up to 13 visits at the clinic: screening; at least 5 and up to 10 treatment (Tx) visits 14+/-3 days apart, and follow up (FU) visits at 1 and 3 months (each can be +/-7 days out of window) after the last treatment session. See Figure 3: Study Design for an illustration of the study design, for a summary of the study procedures and Table 1 for the schedule of times and events. The study population will include up to 35 healthy subjects.


Recruitment information / eligibility

Status Active, not recruiting
Enrollment 31
Est. completion date March 2022
Est. primary completion date January 2022
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 18 Years to 45 Years
Eligibility Inclusion Criteria: - Subjects with noticeable alopecia of the following types: androgenic alopecia, telogen effluvium and alopecia areata - Experiencing active hair loss within the last 1 months but no longer than 5 years - Male/Female hair pattern loss base on: 1. Male presenting Norwood Hamilton Scale - Stage 1 and up to 4 2. Female presenting Sinclair Grade I-IV - Subjects in general good health - Male and female, age 18-45 years old - Women of child-bearing potential that agree to abstain from pregnancy or breastfeeding during the course of the study - Women of child-bearing potential are required to use a reliable method of birth control (such as an intrauterine device, birth control pills, condom with spermicidal, NuvaRing, partner with vasectomy, Implanon or other approved devices, or abstinence) at least 3 months prior to enrollment and throughout the course of the study - Willing to remain on the same diet/habits (per physician recommendation) - Subject is willing and able to comply with protocol requirements and all study visits - Subject is willing and able to provide a written informed consent Exclusion Criteria: - Male/Female hair pattern loss base on: 1. Male presenting Norwood Hamilton Scale - Stage 5 and up to 7 2. Female presenting Sinclair Grade V - Subjects who suffer from scarring alopecia or alopecia totalis - Women who are pregnant, lactating, or less than 6 months post-lactation completion, possibly pregnant or planning a pregnancy during the study period - Currently participating in or recently participated in another clinical trial (within the last 90 days) - Has photosensitivity to laser treatment Previous/Current Alopecia Treatment - Has used during the six months prior to screening or is currently on any of the following medications: finasteride (or any other 5a-reductase inhibitor medications), medications with anti-androgenic properties, topical estrogen, progesterone, tamoxifen, anabolic steroids, medications which can potential cause hypertrichosis, oral glucocorticoids, lithium, phenothiazines, or other medication at the discretion of the investigator - Has used during 6 months prior to screening or is currently on Minoxidil - Has used oral phytotherapy within 2 months prior to study Treatment area related - Subject who color (any type of dye) their hair less than 2 weeks prior to treatment and can't withhold dying their hair during the course of the treatment period. - Has any active skin infection in the scalp or scarring - Has had hair transplants, scalp reduction, current hair weave or tattooing in the target area, which makes it difficult to perform treatment and assessments - Has a chronic dermatological condition (eczema, psoriasis, infection, etc.) of the scalp - Has ever received radiation therapy to the scalp Medical Conditions - History of cancer with the exception of (1) successfully treated basal cell or squamous cell carcinoma of the skin or (2) subjects with a history of successfully treated cancer that have been disease-free for five years (not in the treatment area) - Any current cancer, or has had chemotherapy in the past year - Bleeding disorders and/or using anti-platelet and anticoagulant medication - Uncontrolled systemic disease (diabetes) or infection - History of hypogonadism - Has significant systemic illness - Has a known underlying medical problem that could influence hair growth such as HIV infection, connective tissue disease, a thyroid condition, inflammatory bowel disease or other medical conditions, at the discretion of the investigator. - Has used Accutane in the past 6 months - Has a history of poor wound healing - Has a history of keloid formation - Has a history or evidence of heavy smoking (more than 1 package/20 cigarettes a day), any drug and/or alcohol abuse (over 500ml of 40% hard liquor a week) within the 12 months prior to study - Significant concurrent illness that, in the investigator's opinion would interfere with the subject's participation in the study.

Study Design


Related Conditions & MeSH terms


Intervention

Device:
1565nm non ablative fractional laser
The ResurFX module contains Erbium:Glass Fiber Laser Technology with wavelength of 1565 nm, which is transferred to the ResurFX handpiece via a fiber.

Locations

Country Name City State
Ukraine AMG Lviv

Sponsors (1)

Lead Sponsor Collaborator
Lumenis Ltd.

Country where clinical trial is conducted

Ukraine, 

Outcome

Type Measure Description Time frame Safety issue
Primary Hair Density Improvement evaluate the change in hair density in the target area hair count between baseline and follow up (at 1 month following last treatment), as assessed by scalp macro-imaging. week 0 and week 24 week follow up
Secondary Subjective Improvement Subjective global assessment of hair regrowth by subjects and the investigator at 1 and 3 months following last treatment using a 5-point improvement scale 24 week and 32 week follow up
Secondary Hair Density Improvement Change in hair density in the target area between baseline and 3 month following last treatment, as assessed by scalp macro-imaging. week 0 and week 32 week follow up
Secondary Adverse events Skin safety throughout the study as determined by the investigator by examining the post-treatment occurrences of complications and adverse events week: 2, 4, 6, 8, 10, 12, 14, 16, 18, 20, 24, 32
See also
  Status Clinical Trial Phase
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
Completed NCT01590238 - Enhancing Hair Density With Platelet Rich Fibrin Matrix (PRFM) Phase 3
Not yet recruiting NCT01557491 - Hair Regrowth After Bicoronal Incision N/A
Terminated NCT02935569 - Compression Headband Use to Prevent Hair Loss During Whole Brain Radiotherapy N/A
Completed NCT00515762 - Prevention of Persistent Alopecia Following Docetaxel by Means of Scalp Cooling Phase 2