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1565nm Non-ablative Fractional Laser Treat Alopecia Areata

Primary Purpose

Alopecia Areata

Status
Recruiting
Phase
Not Applicable
Locations
China
Study Type
Interventional
Intervention
1565nm Non-ablative Fractional Laser
placebo
Sponsored by
Second Affiliated Hospital, School of Medicine, Zhejiang University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Alopecia Areata focused on measuring Alopecia Areata, 1565nm Non-ablative Fractional Laser, immune privilege

Eligibility Criteria

18 Years - 55 Years (Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Xianjie WuRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

Laser group

control group

Arm Description

Every 3 weeks, a fixed 1 / 2 of the alopecia area was treated with a 1565-nm non-ablative fractional laser.

There was no treatment for the other half of the alopecia area in the patients.

Outcomes

Primary Outcome Measures

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.
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.

Secondary Outcome Measures

Full Information

First Posted
February 7, 2023
Last Updated
February 23, 2023
Sponsor
Second Affiliated Hospital, School of Medicine, Zhejiang University
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1. Study Identification

Unique Protocol Identification Number
NCT05744505
Brief Title
1565nm Non-ablative Fractional Laser Treat Alopecia Areata
Official Title
1565nm Non-ablative Fractional Laser Treat Alopecia Areata
Study Type
Interventional

2. Study Status

Record Verification Date
February 2023
Overall Recruitment Status
Recruiting
Study Start Date
November 10, 2022 (Actual)
Primary Completion Date
November 10, 2023 (Anticipated)
Study Completion Date
November 10, 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Second Affiliated Hospital, School of Medicine, Zhejiang University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No

5. Study Description

Brief Summary
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Alopecia Areata
Keywords
Alopecia Areata, 1565nm Non-ablative Fractional Laser, immune privilege

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
10 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Laser group
Arm Type
Experimental
Arm Description
Every 3 weeks, a fixed 1 / 2 of the alopecia area was treated with a 1565-nm non-ablative fractional laser.
Arm Title
control group
Arm Type
Placebo Comparator
Arm Description
There was no treatment for the other half of the alopecia area in the patients.
Intervention Type
Procedure
Intervention Name(s)
1565nm Non-ablative Fractional Laser
Intervention Description
Every 3 weeks
Intervention Type
Procedure
Intervention Name(s)
placebo
Intervention Description
Every 3 weeks
Primary Outcome Measure Information:
Title
Change from Baseline alopecia area at one year
Description
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.
Time Frame
baseline and 3, 9, 12 months after the first treatment
Title
Change from Baseline scalp biopsy at one week after the second laser treatment
Description
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.
Time Frame
baseline and one week after the second laser treatment

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
55 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Xianjie Wu, doctor
Phone
13750888267
Email
wuxianjie@zju.edu.cn
Facility Information:
Facility Name
Xianjie Wu
City
Hangzhou
State/Province
Zhejiang
ZIP/Postal Code
310009
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Xianjie Wu
Phone
13750888267
Email
wuxianjie@zju.edu.cn

12. IPD Sharing Statement

Learn more about this trial

1565nm Non-ablative Fractional Laser Treat Alopecia Areata

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