1565nm Non-ablative Fractional Laser Treat Alopecia Areata

The goal of this clinical trial is to evaluate and explore the mechanism of 1565-nm non-ablative fractional laser in the treatment of alopecia areata. The main questions it aims to answer are: (a) comparing the secretion of various cells and cytokines around and within hair follicles before and after treatment; (b) determining the Lord Want effector cells with cytokines and demonstrating that they mediate involvement in correcting the immune immunity collapse process. Participants' 1/2 of the treated alopecia area was compared to their own other half of the untreated alopecia area, and they were followed every three months for efficacy assessment and scalp biopsy.

Study Overview

• Status: Recruiting
• Conditions: Alopecia Areata
• Intervention / Treatment: Procedure: 1565nm Non-ablative Fractional Laser; Procedure: placebo

• Study Type: Interventional
• Enrollment (Anticipated): 10
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Xianjie Wu, doctor; Phone Number: 13750888267; Email: wuxianjie@zju.edu.cn

Study Locations

• China
  • Zhejiang
    • Hangzhou, Zhejiang, China, 310009
      • Recruiting
      • Xianjie Wu
      • Contact: Xianjie Wu; Phone Number: 13750888267; Email: wuxianjie@zju.edu.cn

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 55 years (Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• Male or female subjects aged ≥ 18 years and ≤ 55 years of age;
• Alopecia areata subjects, and diagnosed with alopecia areata for 6 -12 months before screening;
• Women of childbearing age, non-pregnant or lactating, and subjects and their partners voluntarily take contraceptive measures deemed effective by the investigator during treatment and for at least 6 months after the last trial;
• Those who have no contraindications to the use of materials;
• Subject is able to understand and voluntarily sign the written informed consent form, which must be signed prior to the execution of any trial-specified study procedures;
• Subjects must be voluntary and able to complete the study procedure and follow-up examination.

Exclusion Criteria:

• Subjects who meet the diagnostic criteria for alopecia areata but are accompanied by the following diseases cannot be enrolled: local infection (bacterial, fungal or viral) at the site requiring laser treatment; Have a psychiatric disorder (e.g., schizophrenia, neurosis, organic psychosis, etc.);
• Subjects who have previously treated drugs or surgeries and cannot be enrolled in the following situations: receiving other anti-alopecia areata treatments (including topical glucocorticoids,microneedling, laser treatment, etc.) at the same time; Receiving any other clinical investigational drug treatment concurrently;
• Any other situation or condition in which the investigator considers that the subject is not suitable to participate in this study.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Laser group; Every 3 weeks, a fixed 1 / 2 of the alopecia area was treated with a 1565-nm non-ablative fractional laser.	Procedure: 1565nm Non-ablative Fractional Laser; Every 3 weeks
Placebo Comparator: control group; There was no treatment for the other half of the alopecia area in the patients.	Procedure: placebo; Every 3 weeks

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change from Baseline alopecia area at one year	The range of alopecia area in patients receiving 1565nm Non-ablative Fractional Laser treatment was assessed by the hair loss severity scoring tool (SALT) to evaluate the efficacy every three months. The higher the score, the more severe the hair loss and the less effective the treatment.	baseline and 3, 9, 12 months after the first treatment
Change from Baseline scalp biopsy at one week after the second laser treatment	Single-cell sequencing will be used to analyze CD8 + NKG 2 D + T cells, Th 1, Th 2, Th 17, and Treg cells before and after treatment, analyzing differences in cytokine secretion.	baseline and one week after the second laser treatment

Collaborators and Investigators

• Sponsor: Second Affiliated Hospital, School of Medicine, Zhejiang University

Study record dates

Study Major Dates

• Study Start (Actual): November 10, 2022
• Primary Completion (Anticipated): November 10, 2023
• Study Completion (Anticipated): November 10, 2024

Study Registration Dates

• First Submitted: February 7, 2023
• First Submitted That Met QC Criteria: February 23, 2023
• First Posted (Estimate): February 27, 2023

Study Record Updates

• Last Update Posted (Estimate): February 27, 2023
• Last Update Submitted That Met QC Criteria: February 23, 2023
• Last Verified: February 1, 2023

More Information

Terms related to this study

• Keywords: Alopecia Areata; 1565nm Non-ablative Fractional Laser; immune privilege
• Additional Relevant MeSH Terms: Skin Diseases; Pathological Conditions, Anatomical; Hypotrichosis; Hair Diseases; Alopecia; Alopecia Areata
• Other Study ID Numbers: 2022-0797

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No