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

Androgenic Alopecia Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05827991
• Other study ID #: XijingH-PF-KY20222044-F-1
• Status: Recruiting
• Phase: N/A
• Start date: March 1, 2022
• Est. completion date: December 31, 2023

Study information

• Verified date: January 2023
• Source: Xijing Hospital
• Contact: Lin Gao, PhD
• Phone: +8602984775401
• Email: gaolin[@]fmmu.edu.cn
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 75
• Est. completion date: December 31, 2023
• Est. primary completion date: December 31, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 40 Years

Eligibility

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.

Related Conditions & MeSH terms

• Alopecia
• Alopecia Areata
• Androgenic Alopecia

Intervention

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.

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.

Device:
• 1565nm Non-ablative Fractional Laser combined with 5% minoxidil
The two treatment mentioned above

Locations

Country	Name	City	State
China	Dermatology Derpartment of Xijing Hospital	Xi'an	Shaanxi

Sponsors (1)

Lead Sponsor	Collaborator
Xijing Hospital

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	BMI	weight and height will be combined to report BMI in kg/m^2	2 weeks