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

NCT ID: NCT05827991

Last Updated: 2023-04-25

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: NA
• Total Enrollment: 75 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2022-03-01
• Study Completion Date: 2023-12-31

Brief 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.

Conditions

Androgenic Alopecia

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: CROSSOVER
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

1565nm Non-ablative Fractional Laser

1565nm Non-ablative Fractional Laser

Group Type: EXPERIMENTAL

1565nm Non-ablative Fractional Laser

Intervention Type: DEVICE

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.

Minoxidil

Minoxidil for external use

Group Type: ACTIVE_COMPARATOR

5% minoxidil external use

Intervention Type: DRUG

The method of use of 5% minoxidil tincture is for topical use on the scalp, 1 ml per time, 2 times per day.

1565nm Non-ablative Fractional Laser combined with Minoxidil for external use

1565nm Non-ablative Fractional Laser combined with Minoxidil for external use

Group Type: ACTIVE_COMPARATOR

1565nm Non-ablative Fractional Laser combined with 5% minoxidil

Intervention Type: DEVICE

The two treatment mentioned above

Interventions

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.

Intervention Type: DEVICE

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.

Intervention Type: DRUG

1565nm Non-ablative Fractional Laser combined with 5% minoxidil

The two treatment mentioned above

Intervention Type: DEVICE

Eligibility Criteria

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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 40 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Xijing Hospital

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Dermatology Derpartment of Xijing Hospital

Xi'an, Shaanxi, China

Site Status: RECRUITING

Countries

China

Central Contacts

Lin Gao, PhD

Role: CONTACT

gaolin@fmmu.edu.cn

+8602984775401 ext. 029

Chen Yu, PhD

Role: CONTACT

ycyc-2005@163.com

_8613571991903 ext. 029

Facility Contacts

Gang Wang, prof

Role: primary

xjwgang@fmmu.edu.cn

+8684775401

Other Identifiers

XijingH-PF-KY20222044-F-1

Identifier Type: -

Identifier Source: org_study_id