1565nm Non-ablative Fractional Laser Treat Alopecia Areata

NCT05744505 | Unknown

• 1 other identifier: 2022-0797
• Study Type: interventional
• Target: 10
• Locations: 1 country
• Sites: 1

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.

Conditions

Alopecia Areata

Keywords

Alopecia Areata; 1565nm Non-ablative Fractional Laser; immune privilege

Outcome Measures

Primary Outcomes (2)

• 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

Study Arms (2)

Laser group

EXPERIMENTAL

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

control group

PLACEBO COMPARATOR

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

Procedure: placebo

Interventions

1565nm Non-ablative Fractional Laser PROCEDURE

Every 3 weeks

Laser group

placebo PROCEDURE

Every 3 weeks

control group

Eligibility Criteria

• Age: 18 Years - 55 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

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

Study Sites (1)

Xianjie Wu

Hangzhou, Zhejiang, 310009, China

RECRUITING

MeSH Terms

Conditions

Alopecia Areata

Condition Hierarchy (Ancestors)

Alopecia; Hypotrichosis; Hair Diseases; Skin Diseases; Skin and Connective Tissue Diseases

Central Study Contacts

Xianjie Wu, doctor

CONTACT

13750888267; wuxianjie@zju.edu.cn

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 7, 2023
• First Posted: February 27, 2023
• Study Start: November 10, 2022
• Primary Completion: November 10, 2023
• Study Completion: November 10, 2024
• Last Updated: February 27, 2023

Record last verified: 2023-02

Locations

CN (1)