1470nm laser för behandling av androgenetisk alopeci och ärrbildande alopeci
En pilotstudie som utvärderar säkerheten och effektiviteten hos en 1470nm laser för behandling av androgenetisk alopeci och ärrbildande alopeci
Single-center, open-label, baseline-controlled, pilot study evaluating the use of a Nonablative 1470 nm laser for the treatment of androgenetic alopecia and scarring alopecia.
Studieöversikt
Status
Betingelser
Intervention / Behandling
Detaljerad beskrivning
Single-center, open-label, baseline-controlled, pilot study evaluating the use of a Nonablative 1470 nm laser for the treatment of androgenetic alopecia and scarring alopecia. The study may enroll up to 10 participants looking for improvement in their hair loss. All participants will have biopsy-proven alopecia before enrollment. There will be two treatment arms with 5 participants in the androgenetic alopecia arm and 5 participants in the scarring alopecia arm. Multiple treatment areas of the scalp may be performed. Each subject will receive up to three treatments. Follow-up visits are planned for months 6, 9, 12, and 15. Standardized photography, hair density measurement of the treated scalp 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.
For this study, the investigators will use non-ablative HALO laser (1470nm) (Sciton). The non-ablative fractionated treatments with minimal downtime provide synergistic benefit of minimizing tissue damage while improving treatment tolerance and efficiency. The laser works by creating micro-channels in the dermis of the pilosebaceous unit, while leaving bridges of untouched tissue for improved permeability, faster healing, and enhanced delivery of topical treatments. The laser creates controlled zones of coagulation within the dermis. The parameters of the laser will be set according to optimal operation protocol and in accordance with guidelines set forth by Sciton. Each laser treatment will take approximately 10 to 15 minutes per subject. Pretreatment procedure will consist of topical anesthetic then cleaning of the affected area of the scalp with antiseptic, either 70% ethanol or 3% hydrogen peroxide. Post-treatment care will follow standard of care, including the application of topical betamethasone dipropionate cream 0.05% to the treated area. The U.S. Food and Drug Administration (FDA) has cleared the 1470 nm laser for dermatologic purposes. This study will use the laser off-label for the treatment of alopecia. This laser has been approved for the treatment of skin, however, it has not been tested for the treatment of androgenetic alopecia or scarring alopecia, thus this is a novel study to investigate its effectiveness
The follow up phase will consist of clinical assessments including before and after photographs graded by blinded observers and hair density evaluation using Canfield HairMetrix ® device. Subjects are instructed to inform clinical staff after the treatment if they experience any adverse events and will complete patient questionnaires, pain score, and self-assessment of hair growth.
Studietyp
Inskrivning (Beräknad)
Fas
- Inte tillämpbar
Kontakter och platser
Studiekontakt
- Namn: Ryan Chan, BA
- Telefonnummer: 631-553-2203
- E-post: ryachan@montefiore.org
Studera Kontakt Backup
- Namn: Kseniya Kobets
Studieorter
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New York
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Elmsford, New York, Förenta staterna, 10523
- Rekrytering
- Montefiore Einstein Advanced Care
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Kontakt:
- Gabriela Gjini
- Telefonnummer: 914-457-4130
- E-post: ggjini@montefiore.org
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-
Deltagandekriterier
Urvalskriterier
Åldrar som är berättigade till studier
Tar emot friska volontärer
Kön som är behöriga för studier
Beskrivning
Inclusion Criteria:
- Healthy males and females, ≥ 18 years of age at time of informed consent, seeking treatment for hair loss
- Subject must voluntarily sign and date an IRB approved informed consent form
- Subjects with diagnosis of biopsy proven androgenetic alopecia or scarring alopecia with hair loss recorded over the past 6 months
- Subjects must have a stable hair loss treatment regimen with a plateau in results for at least 3 months
- Able to read, understand and voluntarily provide written informed consent
- Subject is determined to be healthy, non-smoker who agrees not to make any changes to their daily hair treatment regimen 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
Exclusion Criteria:
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Subject does not have the capacity to consent to the study
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Subject has other types of alopecia of the scalp like alopecia areata
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History of intralesional steroid injections to the scalp in the last 12 months
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Pregnant women
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Any medical condition that in the consideration of the investigator, would present an increased risk of a photosensitivity reaction to the subject
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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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Allergy or history of prior reaction to lidocaine
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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
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History or current use of the following prescription medications:
i. Immunosuppressive medications/biologics, 6 months prior to and during the study ii. Accutane or other systemic retinoids within the past twelve months
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Smoking or vaping in the past 12 months
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History of uncontrolled hyperlipidemia, diabetes mellitus, hepatitis, or bleeding disorders
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History of major depressive disorders or endocrine disorders including but not limited to; hypothyroidism, Hashimoto's thyroiditis, or hyperthyroidism
Studieplan
Hur är studien utformad?
Designdetaljer
- Primärt syfte: Behandling
- Tilldelning: Icke-randomiserad
- Interventionsmodell: Parallellt uppdrag
- Maskning: Ingen (Open Label)
Vapen och interventioner
Deltagargrupp / Arm |
Intervention / Behandling |
|---|---|
|
Experimentell: Androgenetic Alopecia
The parameters of the laser will be set according to optimal operation protocol and in accordance with guidelines set forth by Sciton. Each laser treatment will take approximately 10 to 15 minutes per subject to target androgenetic alopecia. |
Patients will be treated with the 1470nm non-ablative laser. |
|
Experimentell: Scarring Alopecia
The parameters of the laser will be set according to optimal operation protocol and in accordance with guidelines set forth by Sciton. Each laser treatment will take approximately 10 to 15 minutes per subject to target scarring alopecia. |
Patients will be treated with the 1470nm non-ablative laser. |
Vad mäter studien?
Primära resultatmått
Resultatmått |
Åtgärdsbeskrivning |
Tidsram |
|---|---|---|
|
Live and Photographic assessment of hair loss
Tidsram: Month 1 (baseline), Month 2, Month 3, Month 6, Month 9, Month 12, Month 15
|
Live and Photographic assessment of hair loss will be assessed using the 7-point Clinician rated Global Aesthetic Improvement Scale (CGAIS). The GAIS is a standardized tool used in dermatology and aesthetic medicine to evaluate treatment success for hair loss (such as androgenetic and scarring alopecia). The 7-point GAIS is scored using a scale ranging from -3 (Greatly decreased - hair growth and density) to 3 (Greatly increased - hair growth and density). A score of zero represents no change. |
Month 1 (baseline), Month 2, Month 3, Month 6, Month 9, Month 12, Month 15
|
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Hair Density
Tidsram: Month 1 (baseline), and during the four follow-up periods at Month 6, Month 9, Month 12, and Month 15 (i.e., up to 14 months after initial treatment)
|
Hair density will be assessed using the Canfield HairMetrix imaging device. The average number of hairs per follicular unit will be summarized by arm using descriptive statistics. |
Month 1 (baseline), and during the four follow-up periods at Month 6, Month 9, Month 12, and Month 15 (i.e., up to 14 months after initial treatment)
|
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Hair Counts
Tidsram: Month 1 (baseline), and during the four follow-up periods at Month 6, Month 9, Month 12, and Month 15 (i.e., up to 14 months after initial treatment)
|
Hair counts will also be assessed using the Canfield HairMetrix imaging device. Hair counts/cm^2 will be summarized by study arm using descriptive statistics. |
Month 1 (baseline), and during the four follow-up periods at Month 6, Month 9, Month 12, and Month 15 (i.e., up to 14 months after initial treatment)
|
Sekundära resultatmått
Resultatmått |
Åtgärdsbeskrivning |
Tidsram |
|---|---|---|
|
Subject Satisfaction - Overall
Tidsram: Month 1, Month 2, Month 3, Month 6, Month 9, Month 12, and Month 15
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Overall subject satisfaction will be assessed using a Patient Satisfaction Questionnaire (PSQ). Participants will be asked to complete the assessment while referring to their image in the mirror and current post-treatment photos compared to baseline photos. Specifically, participants will be asked to "Please choose the option that better represents the change in how your hair looks OVERALL in the area treated?" using a scale ranging from -3 (Greatly decreased) to 3 (Greatly increased). A score of zero represents no change. Scores will be summarized by study arm using descriptive statistics. |
Month 1, Month 2, Month 3, Month 6, Month 9, Month 12, and Month 15
|
|
Subject Satisfaction - Hair Thickness
Tidsram: Month 1, Month 2, Month 3, Month 6, Month 9, Month 12, and Month 15
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Subject satisfaction with hair thickness will be assessed using a Patient Satisfaction Questionnaire (PSQ). Participants will be asked to complete the assessment while referring to their image in the mirror and current post-treatment photos compared to baseline photos. Specifically, participants will be asked to "Please choose the option that better represents the change in your hair THICKNESS in the area treated?" using a scale ranging from -3 (Greatly decreased) to 3 (Greatly increased). A score of zero represents no change. Scores will be summarized by study arm using descriptive statistics. |
Month 1, Month 2, Month 3, Month 6, Month 9, Month 12, and Month 15
|
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Subject Satisfaction - Hair Shedding/Loss
Tidsram: Month 1, Month 2, Month 3, Month 6, Month 9, Month 12, and Month 15
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Subject satisfaction with hair shedding/loss will be assessed using a Patient Satisfaction Questionnaire (PSQ). Participants will be asked to complete the assessment while referring to their image in the mirror and current post-treatment photos compared to baseline photos. Specifically, participants will be asked to "Please choose the option that better represents the change in your hair SHEDDING/LOSS in the area treated?" using a scale ranging from -3 (Greatly decreased) to 3 (Greatly increased). A score of zero represents no change. Scores will be summarized by study arm using descriptive statistics. |
Month 1, Month 2, Month 3, Month 6, Month 9, Month 12, and Month 15
|
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Subject Satisfaction - Hair Darkness
Tidsram: Month 1, Month 2, Month 3, Month 6, Month 9, Month 12, and Month 15
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Subject satisfaction with hair darkness will be assessed using a Patient Satisfaction Questionnaire (PSQ). Participants will be asked to complete the assessment while referring to their image in the mirror and current post-treatment photos compared to baseline photos. Specifically, participants will be asked to "Please choose the option that better represents the change in your hair DARKNESS in the area treated?" using a scale ranging from -3 (Greatly decreased) to 3 (Greatly increased). A score of zero represents no change. Scores will be summarized by study arm using descriptive statistics. |
Month 1, Month 2, Month 3, Month 6, Month 9, Month 12, and Month 15
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Subject Satisfaction - Satisfaction with Treatment
Tidsram: Month 1, Month 2, Month 3, Month 6, Month 9, Month 12, and Month 15
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Subject satisfaction with treatment will be assessed using a Patient Satisfaction Questionnaire (PSQ). Participants will be asked to complete the assessment while referring to their image in the mirror and current post-treatment photos compared to baseline photos. Specifically, participants will be asked "How would you characterize your satisfaction with the treatment?" based on the following ordinal scale: Very Satisfied; Satisfied; Slightly Satisfied; Neither satisfied nor dissatisfied; or Dissatisfied. Results will be summarized by study arm. |
Month 1, Month 2, Month 3, Month 6, Month 9, Month 12, and Month 15
|
Samarbetspartners och utredare
Sponsor
Samarbetspartners
Utredare
- Huvudutredare: Kseniya Kobets, MD, Albert Einstein College of Medicine Montefiore Medical Center
Studieavstämningsdatum
Studera stora datum
Studiestart (Faktisk)
Primärt slutförande (Beräknad)
Avslutad studie (Beräknad)
Studieregistreringsdatum
Först inskickad
Först inskickad som uppfyllde QC-kriterierna
Första postat (Faktisk)
Uppdateringar av studier
Senaste uppdatering publicerad (Faktisk)
Senaste inskickade uppdateringen som uppfyllde QC-kriterierna
Senast verifierad
Mer information
Termer relaterade till denna studie
Ytterligare relevanta MeSH-villkor
Andra studie-ID-nummer
- 2022-14192
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