AlopeciaNCT04953416
Fractional Non-ablative Laser for the Treatment of Hair Loss
A study testing 1565nm non ablative fractional laser in people with Alopecia, run by Lumenis Be Ltd. at 1 site in Ukraine.
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. Read more about this study
- Who is it for?
- Ages 18 to 45 yearsHealthy volunteers can take part
- Conditions the study is for
- Alopecia
- What is being tested?
- 1565nm non ablative fractional laser
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 31 participants
- Where
- 1 siteUkraine
- Study dates
- 8 Sep 2020to Mar 2022
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 45 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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:
- Male presenting Norwood Hamilton Scale - Stage 1 and up to 4
- Female presenting Sinclair Grade I-IV
- Subjects in general good health
Show all 12Show fewer
- 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
Who cannot join
- Male/Female hair pattern loss base on:
- Male presenting Norwood Hamilton Scale - Stage 5 and up to 7
- 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)
Show all 30Show fewer
- 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 5α-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.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Evaluation of Safety and Performance of Fractional Non-ablative Laser for the Treatment of Hair Loss - A Pilot Study
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.
Read the detailed 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.
- Conditions
- Alopecia
- Being tested
- 1565nm non ablative fractional laser
- Medical subject headings
- Alopecia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
1565nm non ablative fractional laserDevice
Also called ResurFX by Lumenis Ltd.
The ResurFX module contains Erbium:Glass Fiber Laser Technology with wavelength of 1565 nm, which is transferred to the ResurFX handpiece via a fiber.
| Study group | Role | What they receive |
|---|---|---|
| Scalp treatment with ResurFX | Experimental | Not described Receives: Device: 1565nm non ablative fractional laser |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: week 0 and week 24 week follow up
Secondary outcomes (3)
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
Measured: 24 week and 32 week follow up
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.
Measured: week 0 and week 32 week follow up
Adverse events
Skin safety throughout the study as determined by the investigator by examining the post-treatment occurrences of complications and adverse events
Measured: week: 2, 4, 6, 8, 10, 12, 14, 16, 18, 20, 24, 32
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Jul 2021
- Study start8 Sep 2020
- Primary completionJan 2022 (estimated)
- Study completionMar 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for AlopeciaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 31 participants (actual)
Sponsor and investigators
- Lead sponsor
- Lumenis Be Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Olga Yarish, MD, Principal investigator, AMG clinic
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04953416
- Sponsor's protocol ID
- LUM-ABU-M22-ResurFX-19-01
- Status last verified
- Jul 2021
- First submitted
- 29 Jun 2021
- Last updated
- 8 Jul 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: As this is a feasibility evaluation we do not want to publish yet.
Study at a glance
From the registry record, last updated by the sponsor on 8 Jul 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of Safety and Performance of Fractional Non-ablative Laser for the Treatment of Hair Loss - A Pilot Study
- ClinicalTrials.gov ID
- NCT04953416
- Acronym / sponsor ID
- LUM-ABU-M22-ResurFX-19-01
- Conditions
- Alopecia
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 31 participants (actual)
- Lead sponsor
- Lumenis Be Ltd.Industry (pharma, biotech, devices)
- Study start
- 8 Sep 2020 (actual)
- Primary completion
- Jan 2022 (estimated)
- Study completion
- Mar 2022 (estimated)
- First posted
- 8 Jul 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed 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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Scalp treatment with ResurFX | Experimental | Device: 1565nm non ablative fractional laser |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (12 listed)
- 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:
- Subjects in general good health
- Male and female, age 18-45 years old
Key exclusion criteria (30 listed)
- Male/Female hair pattern loss base on:
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 1565nm non ablative fractional laserAlso: ResurFX by Lumenis Ltd.The ResurFX module contains Erbium:Glass Fiber Laser Technology with wavelength of 1565 nm, which is transferred to the ResurFX handpiece via a fiber. | Device | Scalp treatment with ResurFX |
Primary outcome
Hair Density Improvement
Time frame: week 0 and week 24 week follow up
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.
3 secondary outcomes
Subjective Improvement
Time frame: 24 week and 32 week follow up
Hair Density Improvement
Time frame: week 0 and week 32 week follow up
Adverse events
Time frame: week: 2, 4, 6, 8, 10, 12, 14, 16, 18, 20, 24, 32
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Jul 2021.
- Individual participant dataSharing planned: No. As this is a feasibility evaluation we do not want to publish yet.
Related trials for Alopecia
Active, not recruitingPhase 3
A Study to Learn About Medicine Called Ritlecitinib in Children Aged Between 6 to 12 Years With Severe Alopecia Areata
Severe Alopecia Areata
RecruitingPhase 2
Evaluate the Efficacy and Safety of Ruxolitinib on Hair Regrowth in Patients With Autoimmune Polyendocrinopathy Candidiasis Ectodermal Dystrophy (APECED)-Associated Alopecia Areata
Autoimmune Polyendocrinopathy Candidiasis Ectodermal Dystrophy (Apeced), Alopecia Areata
Active, not recruitingObservational study
Litfulo Capsules Special Investigation
Alopecia Areata
Active, not recruitingObservational study
Real-World Effectiveness of Ritlecitinib in Alopecia Areata Patients in the US: A Retrospective Analysis Using EHR and Claims Data
Alopecia Areata
Active, not recruitingObservational study
Characterization And Clinical Outcomes of AA Patients Treated With Ritlecitinib
Alopecia Areata
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Olga Yarish, MD principal investigator
AMG clinic
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing 1565nm non ablative fractional laser in people with Alopecia, run by Lumenis Be Ltd. at 1 site in Ukraine.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 12 inclusion and 30 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 8 Jul 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Ukraine. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Hair Density Improvement (time frame: week 0 and week 24 week follow up). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Jul 2021.