Clinical trial NCT05744505: 1565nm Non-ablative Fractional Laser Treat Alopecia Areata
Official title: 1565nm Non-ablative Fractional Laser Treat Alopecia Areata
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Alopecia Areata
Keywords: Alopecia Areata
1565nm Non-ablative Fractional Laser
immune privilege
Lead sponsor: Second Affiliated Hospital, School of Medicine, Zhejiang University
Sponsor class: OTHER
First posted: 2023-02-27
Enrollment: 10
Sex: ALL
Minimum age (years): 18
Maximum age (years): 55
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


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.

Primary outcomes:
measure: Change from Baseline alopecia area at one year
timeFrame: baseline and 3, 9, 12 months after the first treatment
measure: Change from Baseline scalp biopsy at one week after the second laser treatment
timeFrame: baseline and one week after the second laser treatment
Secondary outcomes:
Other outcomes:
Locations:
city: Hangzhou
country: China
facility: Xianjie Wu
state: Zhejiang
Study officials:
References: