1565nm Non-ablative Fractional Laser Treat Alopecia Areata

NCT ID: NCT05744505

Last Updated: 2023-02-27

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: NA
• Total Enrollment: 10 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2022-11-10
• Study Completion Date: 2024-11-10

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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Laser group

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

Group Type: EXPERIMENTAL

1565nm Non-ablative Fractional Laser

Intervention Type: PROCEDURE

Every 3 weeks

control group

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

Group Type: PLACEBO_COMPARATOR

placebo

Intervention Type: PROCEDURE

Every 3 weeks

Interventions

1565nm Non-ablative Fractional Laser

Every 3 weeks

Intervention Type: PROCEDURE

placebo

Every 3 weeks

Intervention Type: PROCEDURE

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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 55 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Second Affiliated Hospital, School of Medicine, Zhejiang University

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Xianjie Wu

Hangzhou, Zhejiang, China

Site Status: RECRUITING

Countries

China

Central Contacts

Xianjie Wu, doctor

Role: CONTACT

wuxianjie@zju.edu.cn

13750888267

Facility Contacts

Xianjie Wu

Role: primary

wuxianjie@zju.edu.cn

13750888267

Other Identifiers

2022-0797

Identifier Type: -

Identifier Source: org_study_id