1565nm Non-ablative Fractional Laser Treat Alopecia Areata

Zhejiang University

Status: Enrolling

Conditions: Alopecia Areata

Treatments: Procedure: placebo; Procedure: 1565nm Non-ablative Fractional Laser

Study type: Interventional

Funder types: Other

Identifiers

NCT05744505

2022-0797

Details and patient eligibility

About

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.

Enrollment: 10 estimated patients

Sex: All

Ages: 18 to 55 years old

Volunteers: No 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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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10 participants in 2 patient groups, including a placebo group

Laser group

Experimental group

Description:

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

Treatment:

Procedure: 1565nm Non-ablative Fractional Laser

control group

Placebo Comparator group

Description:

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

Treatment:

Procedure: placebo