1565nm Non-ablative Fractional Laser Treat Alopecia Areata

Alopecia Areata Clinical Trial

Official title:

1565nm Non-ablative Fractional Laser Treat Alopecia Areata

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05744505
• Other study ID #: 2022-0797
• Status: Recruiting
• Phase: N/A
• Start date: November 10, 2022
• Est. completion date: November 10, 2024

Study information

• Verified date: February 2023
• Source: Second Affiliated Hospital, School of Medicine, Zhejiang University
• Contact: Xianjie Wu, doctor
• Phone: 13750888267
• Email: wuxianjie[@]zju.edu.cn
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 10
• Est. completion date: November 10, 2024
• Est. primary completion date: November 10, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 55 Years

Eligibility

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.

Related Conditions & MeSH terms

• Alopecia
• Alopecia Areata

Intervention

Procedure:
• 1565nm Non-ablative Fractional Laser
Every 3 weeks
• placebo
Every 3 weeks

Locations

Country	Name	City	State
China	Xianjie Wu	Hangzhou	Zhejiang

Sponsors (1)

Lead Sponsor	Collaborator
Second Affiliated Hospital, School of Medicine, Zhejiang University

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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