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

NCT05827991 | Unknown

• 1 other identifier: XijingH-PF-KY20222044-F-1
• Study Type: interventional
• Target: 75
• Locations: 1 country
• Sites: 1

Brief Summary

1. 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. 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.

Conditions

Androgenic Alopecia

Keywords

1565nm Non-ablative Fractional Laser; Androgenic Alopecia; Treatment

Outcome Measures

Primary Outcomes (2)

• 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

Study Arms (3)

1565nm Non-ablative Fractional Laser

EXPERIMENTAL

1565nm Non-ablative Fractional Laser

Device: 1565nm Non-ablative Fractional Laser

Minoxidil

ACTIVE COMPARATOR

Minoxidil for external use

Drug: 5% minoxidil external use

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

ACTIVE COMPARATOR

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

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

Interventions

1565nm Non-ablative Fractional Laser 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.

1565nm Non-ablative Fractional Laser

5% minoxidil external use DRUG

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

Minoxidil

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

The two treatment mentioned above

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

Eligibility Criteria

• Age: 18 Years - 40 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• Xijing Hospital: lead

Study Sites (1)

Dermatology Derpartment of Xijing Hospital

Xi'an, Shaanxi, 710032, China

RECRUITING

MeSH Terms

Conditions

Alopecia

Condition Hierarchy (Ancestors)

Hypotrichosis; Hair Diseases; Skin Diseases; Skin and Connective Tissue Diseases; Pathological Conditions, Anatomical; Pathological Conditions, Signs and Symptoms

Central Study Contacts

Lin Gao, PhD

CONTACT

+8602984775401; gaolin@fmmu.edu.cn

Chen Yu, PhD

CONTACT

_8613571991903; ycyc-2005@163.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 29, 2023
• First Posted: April 25, 2023
• Study Start: March 1, 2022
• Primary Completion: December 31, 2023
• Study Completion: December 31, 2023
• Last Updated: April 25, 2023

Record last verified: 2023-01

Locations

CN (1)