Androgenetic AlopeciaNCT04882969
Thulium Laser and KeraFactor for the Treatment of Androgenetic Alopecia
A study testing Fractionated Thulium laser in people with Androgenetic Alopecia, run by Montefiore Medical Center at 1 site in United States.
Trial summary
The objective of this clinical study is to assess the safety and efficacy of using a laser and hair growth factors in the treatment of male-pattern hair loss. Participating subjects will receive up to two (2) treatments per month for 6 months with the laser and post-treatment topically applied hair growth factors and… Read more about this study
- Who is it for?
- Ages 18 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Androgenetic Alopecia
- What is being tested?
- Fractionated Thulium laser
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Sep 2021to 31 Dec 2024
- 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 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Subject must voluntarily sign and date an IRB approved informed consent form
- Subjects with diagnosis of androgenetic alopecia with hair loss recorded over the past 6 months. (Ludwig Savin Scale: Class I-4, II-1, II-2 for females and Norwood Hamilton Class 3-4 for males
- Able to read, understand and voluntarily provide written informed consent.
- Healthy male or female, ≥ 18 years of age at time of informed consent up to 65 years of age, seeking treatment for hair loss.
- Subject is determined to be healthy, non-smoker who agrees not to make any changes to their daily hair treatment regime during the study.
- Subjects able and willing to comply with the treatment protocol and follow-up schedule and requirements.
- Understands and accepts the obligation not to undergo any other procedures in the areas to be treated through the follow-up period.
- Women of child-bearing age are required to be using a reliable, non-hormonal method of birth control for the duration of the study. Subjects will be asked to have a negative Urine Pregnancy test at baseline.
Who cannot join
- Subjects does not have the capacity to consent to the study
- Subject has other types of alopecia of the scalp (i.g., alopecia areata, scarring alopecia)
- Use of minoxidil or 5-alpha reductase inhibitors (i.e., finasteride, dutasteride) 3 months prior to screening date.
- Any medical condition that in the consideration of the investigator, would present an increased risk of a photosensitivity reaction to the subject.
- Pregnant in the last 12 months, intending to become pregnant, postpartum or nursing in the last 12 months.
- Any previous surgical procedure in the treatment area in the past 12 months, or major surgery in the last 6 months.
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- History of immunosuppression/immune deficiency disorders (including AIDS and HIV infection), and/or any history of systemic chemotherapy for prior 12 months.
- History or current use of the following prescription medications: Immunosuppressive medications/biologics, 6 months prior to and during the study. Accutane or other systemic retinoids within the past twelve months.
- Smoking or vaping in the past 12 months.
- History of hyperlipidemia, diabetes mellitus, hepatitis, or bleeding disorders.
- History of major depressive disorders or endocrine disorders including but not limited to; hypothyroidism, Hashimoto's thyroiditis, or hyperthyroidism as well as Polycystic Ovarian Syndrome (PCOS) in females.
Trial locations and contacts
1 site in 1 country.
United States1 site
Montefiore Medical Center
The Bronx, New York, 10467
About this study
Official title: A Pilot Study Evaluating the Safety and Efficacy of a Fractionated Thulium Laser and KeraFactor for the Treatment of Alopecia
The objective of this clinical study is to assess the safety and efficacy of using a laser and hair growth factors in the treatment of male-pattern hair loss. Participating subjects will receive up to two (2) treatments per month for 6 months with the laser and post-treatment topically applied hair growth factors and will have a 6 month follow-up period.
Read the detailed description
This is a single-center, open-label, baseline-controlled, study evaluating the use of a Thulium laser (1927nm) and post-treatment topically applied KeraFactor, which contain hair-stimulating growth factors, in the treatment of androgenetic alopecia. The study may enroll up to 20 subjects looking for improvement in their hair loss. Multiple treatment areas per subject may be included. Each subject will receive up to two (2) treatments per month over a 3-month period. Follow Up Visits are planned for 3, and 9 months post last treatment. Standardized photography of the treatment areas will be recorded Pre and Post Treatment at each visit. Measurement outcomes will be compared to baseline. During the initial visit, subjects who meet the study's eligibility criteria will receive the first treatment after signing informed consent form.
The follow up phase will consist of before and after photographs graded by blinded observers. Subjects are instructed to inform clinical staff after the treatment if they experience any adverse events.
- Conditions
- Androgenetic Alopecia
- Being tested
- Fractionated Thulium laser
- Keywords
- alopecia, androgenetic, laser, hair loss
- Medical subject headings
- Alopecia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Fractionated Thulium laserDevice
Also called LaseMD Lutronic Laser
LaseMD Lutronic Laser is a 1927-nm fractionated thulium laser, which is better absorbed by water than non-ablative 1,540-nm erbium glass laser energy. The laser energy and power can be customized to target a specific penetration depth and achieve selective photothermolysis in skin while mitigating injury to surrounding tissue. The thermal energy generated by the laser has been shown to facilitate the delivery of kerafactor, which contain hair growth factors to stimulate follicular progenitor cell proliferation and differentiation into follicular keratinocytes to promote hair growth.
| Study group | Role | What they receive |
|---|---|---|
| Fractionated Thulium Laser and KeraFactor | Experimental | All participating subjects will serve as their own baseline control and will receive treatment of their androgenetic alopecia with LaseMD, a 1927nm Fractionated Thulium laser and post-treatment topically applied KeraFactor every 2 weeks for 12 week period. Receives: Device: Fractionated Thulium laser |
What is being measured
The primary outcome is the main question the study is designed to answer.
Percentage of subjects with score of 2 or 3 on Clinician Global Aesthetic Improvement (CGAIS) scale at week 12 of treatment.
Clinician Global Aesthetic Improvement Scale (CGAIS) is a Likert scale, ranging from "greatly decreased (-3)" hair growth to "greatly increased (+3)" hair growth.
- Greatly decreased (-3)
- Moderately decreased (-2)
- Slightly decreased (-1)
- No change (0)
- Slightly increased (+1)
- Moderately increased (+2)
- Greatly increased (+3)
Based on a live assessment of the subject while referring to the subject's pre-treatment scalp photographs, the clinician will make an assessment of post-treatment hair growth.
Measured: 12 weeks
Percentage of subjects with score of 2 or 3 on Subject Global Aesthetic Improvement at week 12 of treatment.
Subject Global Aesthetic Improvement Scale (SGAIS) is a Likert scale, ranging from "greatly decreased (-3)" hair growth to "greatly increased (+3)" hair growth.
- Greatly decreased (-3)
- Moderately decreased (-2)
- Slightly decreased (-1)
- No change (0)
- Slightly increased (+1)
- Moderately increased (+2)
- Greatly increased (+3)
Subjects will be given a hand mirror for self-assessment of post-treatment hair growth compared to subject's pre-treatment scalp photographs.
Measured: 12 weeks
Secondary outcomes (2)
Percentage of subjects with score of 2 or 3 on Patient Satisfaction Questionnaire at week 12 of treatment.
Patient Satisfaction Questionnaire will use Lickert scale, ranging from "greatly decreased (-3)" to "greatly increased (+3)".
- Greatly decreased (-3)
- Moderately decreased (-2)
- Slightly decreased (-1)
- No change (0)
- Slightly increased (+1)
- Moderately increased (+2)
- Greatly increased (+3)
The seven point Lickert scale will apply to following patient satisfaction questions:
- Please choose the option that better represents the change in how your hair looks OVERALL in the area treated?
- Please choose the option that better represents the change in your hair THICKNESS in the area treated?
- Please choose the option that better represents the change in your hair SHEDDING/LOSS in the area treated?
- Please choose the option that better represents the change in your hair DARKNESS in the area treated.
Measured: 12 weeks
Reported pain score on Numeric Rating Scale for Pain
The Numeric Rating Scale for Pain is an 11-point scale scored from 0-10, with 0 = no pain, 5 = moderate pain, and 10 = worst possible pain. Subjects select a value that is most in line with the intensity of their pain experienced during and after treatment with Thulium Laser and topical Kerafactor.
Measured: 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 May 2021
- Study start1 Sep 2021 (estimated)
- Primary completion30 Jun 2023 (estimated)
- Study completion31 Dec 2024 (estimated)
Why it stopped: Changed Indication
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Androgenetic AlopeciaStudies of the same condition, open and under way.
- More trials run by Montefiore Medical CenterThe sponsor's other registered studies.
- 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
- Model description
- Each participating subject will serve as his or her baseline control and will receive up to two (2) treatments per month for 3 months with Thulium laser and post-laser treatment topically applied Kerafactor.
- Masking
- None (open label)
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Montefiore Medical Center
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Kseniya Kobets, Montefiore Medical Center
- Investigators
- Kseniya Kobets, MD, Principal investigator, Montefiore Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04882969
- Sponsor's protocol ID
- 2021-12914
- Status last verified
- Aug 2021
- First submitted
- 6 May 2021
- Last updated
- 12 Aug 2021
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 12 Aug 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Pilot Study Evaluating the Safety and Efficacy of a Fractionated Thulium Laser and KeraFactor for the Treatment of Alopecia
- ClinicalTrials.gov ID
- NCT04882969
- Acronym / sponsor ID
- 2021-12914
- Conditions
- Androgenetic Alopecia
- Keywords
- alopecia, androgenetic, laser, hair loss
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: Changed Indication
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Montefiore Medical CenterUniversity, hospital or other
- Study start
- 1 Sep 2021 (estimated)
- Primary completion
- 30 Jun 2023 (estimated)
- Study completion
- 31 Dec 2024 (estimated)
- First posted
- 12 May 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.
The objective of this clinical study is to assess the safety and efficacy of using a laser and hair growth factors in the treatment of male-pattern hair loss. Participating subjects will receive up to two (2) treatments per month for 6 months with the laser and post-treatment topically applied hair growth factors and will have a 6 month follow-up period.
Detailed description
This is a single-center, open-label, baseline-controlled, study evaluating the use of a Thulium laser (1927nm) and post-treatment topically applied KeraFactor, which contain hair-stimulating growth factors, in the treatment of androgenetic alopecia. The study may enroll up to 20 subjects looking for improvement in their hair loss. Multiple treatment areas per subject may be included. Each subject will receive up to two (2) treatments per month over a 3-month period. Follow Up Visits are planned for 3, and 9 months post last treatment. Standardized photography of the treatment areas will be recorded Pre and Post Treatment at each visit. Measurement outcomes will be compared to baseline. During the initial visit, subjects who meet the study's eligibility criteria will receive the first treatment after signing informed consent form.
The follow up phase will consist of before and after photographs graded by blinded observers. Subjects are instructed to inform clinical staff after the treatment if they experience any adverse events.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- Each participating subject will serve as his or her baseline control and will receive up to two (2) treatments per month for 3 months with Thulium laser and post-laser treatment topically applied Kerafactor.
| Arm | Type | Receives |
|---|---|---|
| Fractionated Thulium Laser and KeraFactor | Experimental | Device: Fractionated Thulium laserAll participating subjects will serve as their own baseline control and will receive treatment of their androgenetic alopecia with LaseMD, a 1927nm Fractionated Thulium laser and post-treatment topically applied KeraFactor every 2 weeks for 12 week period. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- Subject must voluntarily sign and date an IRB approved informed consent form
- Subjects with diagnosis of androgenetic alopecia with hair loss recorded over the past 6 months. (Ludwig Savin Scale: Class I-4, II-1, II-2 for females and Norwood Hamilton Class 3-4 for males
- Able to read, understand and voluntarily provide written informed consent.
- Healthy male or female, ≥ 18 years of age at time of informed consent up to 65 years of age, seeking treatment for hair loss.
- Subject is determined to be healthy, non-smoker who agrees not to make any changes to their daily hair treatment regime during the study.
Key exclusion criteria (11 listed)
- Subjects does not have the capacity to consent to the study
- Subject has other types of alopecia of the scalp (i.g., alopecia areata, scarring alopecia)
- Use of minoxidil or 5-alpha reductase inhibitors (i.e., finasteride, dutasteride) 3 months prior to screening date.
- Any medical condition that in the consideration of the investigator, would present an increased risk of a photosensitivity reaction to the subject.
- Pregnant in the last 12 months, intending to become pregnant, postpartum or nursing in the last 12 months.
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 |
|---|---|---|
| Fractionated Thulium laserAlso: LaseMD Lutronic LaserLaseMD Lutronic Laser is a 1927-nm fractionated thulium laser, which is better absorbed by water than non-ablative 1,540-nm erbium glass laser energy. The laser energy and power can be customized to target a specific penetration depth and achieve selective photothermolysis in skin while mitigating injury to surrounding tissue. The thermal energy generated by the laser has been shown to facilitate the delivery of kerafactor, which contain hair growth factors to stimulate follicular progenitor cell proliferation and differentiation into follicular keratinocytes to promote hair growth. | Device | Fractionated Thulium Laser and KeraFactor |
Primary outcome
Percentage of subjects with score of 2 or 3 on Clinician Global Aesthetic Improvement (CGAIS) scale at week 12 of treatment.
Time frame: 12 weeks
Clinician Global Aesthetic Improvement Scale (CGAIS) is a Likert scale, ranging from "greatly decreased (-3)" hair growth to "greatly increased (+3)" hair growth. 1. Greatly decreased (-3) 2. Moderately decreased (-2) 3. Slightly decreased (-1) 4. No change (0) 5. Slightly increased (+1) 6. Moderately increased (+2) 7. Greatly increased (+3) Based on a live assessment of the subject while referring to the subject's pre-treatment scalp photographs, the clinician will make an assessment of post-treatment hair growth.
Percentage of subjects with score of 2 or 3 on Subject Global Aesthetic Improvement at week 12 of treatment.
Time frame: 12 weeks
Subject Global Aesthetic Improvement Scale (SGAIS) is a Likert scale, ranging from "greatly decreased (-3)" hair growth to "greatly increased (+3)" hair growth. 1. Greatly decreased (-3) 2. Moderately decreased (-2) 3. Slightly decreased (-1) 4. No change (0) 5. Slightly increased (+1) 6. Moderately increased (+2) 7. Greatly increased (+3) Subjects will be given a hand mirror for self-assessment of post-treatment hair growth compared to subject's pre-treatment scalp photographs.
2 secondary outcomes
Percentage of subjects with score of 2 or 3 on Patient Satisfaction Questionnaire at week 12 of treatment.
Time frame: 12 weeks
Reported pain score on Numeric Rating Scale for Pain
Time frame: 12 weeks
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Aug 2021.
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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.
Kseniya Kobets, MD principal investigator
Montefiore Medical Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Fractionated Thulium laser in people with Androgenetic Alopecia, run by Montefiore Medical Center at 1 site in United States.
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 8 inclusion and 11 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: withdrawn, as of the sponsor's last update on 12 Aug 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 United States. 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?
The study was withdrawn before enrolling participants, so there are no results.
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?
Percentage of subjects with score of 2 or 3 on Clinician Global Aesthetic Improvement (CGAIS) scale at week 12 of treatment. (time frame: 12 weeks). The study lists 2 primary outcomes in all. 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 12 Aug 2021.