Cette page a été traduite automatiquement et l'exactitude de la traduction n'est pas garantie. Veuillez vous référer au version anglaise pour un texte source.

Laser 1470nm pour le traitement de l'alopécie androgénétique et de l'alopécie cicatricielle

29 septembre 2026 mis à jour par: Montefiore Medical Center

Une étude pilote évaluant l'innocuité et l'efficacité d'un laser de 1470 nm pour le traitement de l'alopécie androgénétique et de l'alopécie cicatricielle

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.

Aperçu de l'étude

Statut

Recrutement

Les conditions

Intervention / Traitement

Description détaillée

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.

Type d'étude

Interventionnel

Inscription (Estimé)

10

Phase

  • N'est pas applicable

Contacts et emplacements

Cette section fournit les coordonnées de ceux qui mènent l'étude et des informations sur le lieu où cette étude est menée.

Coordonnées de l'étude

Sauvegarde des contacts de l'étude

  • Nom: Kseniya Kobets

Lieux d'étude

  • États-Unis
    • New York
      • Elmsford, New York, États-Unis, 10523
        • Recrutement
        • Montefiore Einstein Advanced Care
        • Contact:

Critères de participation

Les chercheurs recherchent des personnes qui correspondent à une certaine description, appelée critères d'éligibilité. Certains exemples de ces critères sont l'état de santé général d'une personne ou des traitements antérieurs.

Critère d'éligibilité

Âges éligibles pour étudier

18 ans à 99 ans (Adulte, Adulte plus âgé)

Accepte les volontaires sains

Oui

Sexes éligibles pour l'étude

Tout

La description

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:

  • Subject does not have the capacity to consent to the study

  • Subject has other types of alopecia of the scalp like alopecia areata

  • History of intralesional steroid injections to the scalp in the last 12 months

  • Pregnant women

  • Any medical condition that in the consideration of the investigator, would present an increased risk of a photosensitivity reaction to the subject

  • Any previous surgical procedure in the treatment area in the past 12 months, or major surgery in the last 6 months

  • Allergy or history of prior reaction to lidocaine

  • 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:

    i. Immunosuppressive medications/biologics, 6 months prior to and during the study ii. Accutane or other systemic retinoids within the past twelve months

  • Smoking or vaping in the past 12 months

  • History of uncontrolled 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

Plan d'étude

Cette section fournit des détails sur le plan d'étude, y compris la façon dont l'étude est conçue et ce que l'étude mesure.

Comment l'étude est-elle conçue ?

Détails de conception

  • Objectif principal: Traitement
  • Répartition: Non randomisé
  • Modèle interventionnel: Affectation parallèle
  • Masquage: Aucun (étiquette ouverte)

Armes et Interventions

Groupe de participants / Bras
Intervention / Traitement
Expérimental: 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.
Dispositif: Sciton HALO 1470nm Non-ablative laser

Patients will be treated with the 1470nm non-ablative laser.
Expérimental: 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.
Dispositif: Sciton HALO 1470nm Non-ablative laser

Patients will be treated with the 1470nm non-ablative laser.

Que mesure l'étude ?

Principaux critères de jugement

Mesure des résultats
Description de la mesure
Délai
Live and Photographic assessment of hair loss
Délai: 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
Hair Density
Délai: 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)
Hair Counts
Délai: 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)

Mesures de résultats secondaires

Mesure des résultats
Description de la mesure
Délai
Subject Satisfaction - Overall
Délai: Month 1, Month 2, Month 3, Month 6, Month 9, Month 12, and Month 15

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
Délai: Month 1, Month 2, Month 3, Month 6, Month 9, Month 12, and Month 15

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
Subject Satisfaction - Hair Shedding/Loss
Délai: Month 1, Month 2, Month 3, Month 6, Month 9, Month 12, and Month 15

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
Subject Satisfaction - Hair Darkness
Délai: Month 1, Month 2, Month 3, Month 6, Month 9, Month 12, and Month 15

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
Subject Satisfaction - Satisfaction with Treatment
Délai: Month 1, Month 2, Month 3, Month 6, Month 9, Month 12, and Month 15

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

Collaborateurs et enquêteurs

C'est ici que vous trouverez les personnes et les organisations impliquées dans cette étude.

Parrainer

Montefiore Medical Center

Collaborateurs

Sciton

Les enquêteurs

  • Chercheur principal: Kseniya Kobets, MD, Albert Einstein College of Medicine Montefiore Medical Center

Dates d'enregistrement des études

Ces dates suivent la progression des dossiers d'étude et des soumissions de résultats sommaires à ClinicalTrials.gov. Les dossiers d'étude et les résultats rapportés sont examinés par la Bibliothèque nationale de médecine (NLM) pour s'assurer qu'ils répondent à des normes de contrôle de qualité spécifiques avant d'être publiés sur le site Web public.

Dates principales de l'étude

Début de l'étude (Réel)

7 décembre 2023

Achèvement primaire (Estimé)

1 juillet 2028

Achèvement de l'étude (Estimé)

1 juillet 2028

Dates d'inscription aux études

Première soumission

7 juillet 2022

Première soumission répondant aux critères de contrôle qualité

13 juillet 2022

Première publication (Réel)

15 juillet 2022

Mises à jour des dossiers d'étude

Dernière mise à jour publiée (Réel)

1 octobre 2026

Dernière mise à jour soumise répondant aux critères de contrôle qualité

29 septembre 2026

Dernière vérification

1 septembre 2026

Plus d'information

Termes liés à cette étude

Mots clés

Termes MeSH pertinents supplémentaires

Autres numéros d'identification d'étude

  • 2022-14192

Plan pour les données individuelles des participants (IPD)

Prévoyez-vous de partager les données individuelles des participants (DPI) ?

NON

Informations sur les médicaments et les dispositifs, documents d'étude

Étudie un produit pharmaceutique réglementé par la FDA américaine

Non

Étudie un produit d'appareil réglementé par la FDA américaine

Oui

produit fabriqué et exporté des États-Unis.

Non

Ces informations ont été extraites directement du site Web clinicaltrials.gov sans aucune modification. Si vous avez des demandes de modification, de suppression ou de mise à jour des détails de votre étude, veuillez contacter register@clinicaltrials.gov. Dès qu'un changement est mis en œuvre sur clinicaltrials.gov, il sera également mis à jour automatiquement sur notre site Web .

S'abonner