A Clinical Observation of 1565nm Non-ablative Fractional Laser in the Treatment of Androgenic Alopecia

A Randomized Controlled Trial of the Efficacy and Safety of 1565nm Non-ablative Fractional Laser on Treating Androgenic Alopecia

1. Androgenic alopecia (AGA) is a clinically common non cicatricial, progressive hair follicle microminiaturization disorder that begins in puberty or after puberty. The latest epidemiological survey shows that the prevalence rate of males in China is about 21.3%. In 2021, Nature published an article stating that stress hormones can inhibit hair growth by regulating hair follicle stem cells. This research conclusion provides new evidence for the impact of stress on hair growth. The trend of receiving AGA patients in the investigators' outpatient department is increasing. How to provide rapid, safe, and effective treatment for AGA patients is currently a hot topic for clinicians.
2. Studies have shown that phototherapy can effectively improve androgenic alopecia, alopecia areata, and hair loss after chemotherapy, and promote hair growth. At the same time, phototherapy can also be adjusted by adjusting the expression of reductase genes and vascular endothelial growth factor genes, as well as some endogenous epidermal growth factors, such as fibroblast growth factor and insulin-like growth factor, are also upregulated, which can stimulate hair growth.

3.1565 nm non-ablative fractional laser has the effects of inhibiting sebaceous gland secretion of oil, regulating collagen metabolism, and delaying changes in scalp collagen after hair loss. Previous studies have confirmed that 1565 nm non-ablative fractional laser therapy for alopecia areata has a good effect. Its possible mechanisms include increasing local blood flow, stimulating growth factors and cytokines during hair growth. At the same time, in order to achieve low energy, safe, and effective treatment without the need for hair cutting, the investigators had for the first time improved the 1565 nm non non-ablative fractional laser treatment tool, removing the original sapphire crystal cooling contact. This improvement can make the treatment head fully fit the scalp, and the excitation beam acts vertically on the treatment area, reducing energy attenuation.

Study Overview

• Status: Recruiting
• Conditions: Androgenic Alopecia
• Intervention / Treatment: Device: 1565nm Non-ablative Fractional Laser; Drug: 5% minoxidil external use; Device: 1565nm Non-ablative Fractional Laser combined with 5% minoxidil

• Study Type: Interventional
• Enrollment (Anticipated): 75
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Lin Gao, PhD; Phone Number: 029 +8602984775401; Email: gaolin@fmmu.edu.cn
• Study Contact Backup: Name: Chen Yu, PhD; Phone Number: 029 _8613571991903; Email: ycyc-2005@163.com

Study Locations

• China
  • Shaanxi
    • Xi'an, Shaanxi, China, 710032
      • Recruiting
      • Dermatology Derpartment of Xijing Hospital
      • Contact: Gang Wang, prof; Phone Number: +8684775401; Email: xjwgang@fmmu.edu.cn

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

1. Age: 18-40 years old, regardless of gender;
2. Clinical diagnosis of androgenic alopecia The diagnosis was based on the diagnostic criteria for androgenic alopecia in Clinical Dermatology, edited by Zhao Bian;
3. The patient agrees to participate in this trial and signs an informed consent form;
4. The scalp is free of bleeding, ulceration, infection, and other conditions that affect the visual field of laser surgery.

Exclusion Criteria:

1. Drugs that affect hair growth, including finasteride tablets, glucocorticoids, and vasoactive drugs, have been used within 6 months before treatment;
2. Those who undergo local scalp treatment within 3 months, including topical drugs, medical cosmetic treatment, etc;
3. Combined with severe damage to important organs such as heart, liver, kidney, and brain;
4. Symptomatic alopecia caused by other diseases, such as lupus erythematosus alopecia and folliculitis alopecia;
5. Scar constitution;
6. Patients with skin malignant tumors or precancerous lesions;
7. Pregnant or nursing;
8. Recent skin infections (such as viruses and bacteria);
9. Those who cannot persist in treatment and follow-up.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Crossover Assignment
• Masking: Single

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: 1565nm Non-ablative Fractional Laser	Device: 1565nm Non-ablative Fractional Laser; 1565nm Non-ablative Fractional Laser is used for treatment once every 2 weeks, a total of 10 times. 1565nm Non-ablative Fractional Laser uses square and rectangular light spots, and the size is adjusted according to the treatment area, which is about 8-16mm, 250-300spot, 10J/cm2.
Active Comparator: Minoxidil; Minoxidil for external use	Drug: 5% minoxidil external use; The method of use of 5% minoxidil tincture is for topical use on the scalp, 1 ml per time, 2 times per day.
Active Comparator: 1565nm Non-ablative Fractional Laser combined with Minoxidil for external use	Device: 1565nm Non-ablative Fractional Laser combined with 5% minoxidil; The two treatment mentioned above

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
hair mirror	Using a hair mirror, measure the hair density per unit area of the same part and field of view (the center of the longitudinal axis of the scalp and body), and calculate the number and density of hair per unit area.	2 weeks
BMI	weight and height will be combined to report BMI in kg/m^2	2 weeks

Collaborators and Investigators

• Sponsor: Xijing Hospital

Study record dates

Study Major Dates

• Study Start (Actual): March 1, 2022
• Primary Completion (Anticipated): December 31, 2023
• Study Completion (Anticipated): December 31, 2023

Study Registration Dates

• First Submitted: March 29, 2023
• First Submitted That Met QC Criteria: April 24, 2023
• First Posted (Actual): April 25, 2023

Study Record Updates

• Last Update Posted (Actual): April 25, 2023
• Last Update Submitted That Met QC Criteria: April 24, 2023
• Last Verified: January 1, 2023

More Information

Terms related to this study

• Keywords: Treatment; Androgenic Alopecia; 1565nm Non-ablative Fractional Laser
• Additional Relevant MeSH Terms: Skin Diseases; Pathological Conditions, Anatomical; Hypotrichosis; Hair Diseases; Alopecia; Alopecia Areata; Antihypertensive Agents; Vasodilator Agents; Minoxidil
• Other Study ID Numbers: XijingH-PF-KY20222044-F-1

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No