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

Primary Purpose

Androgenic Alopecia

Status
Recruiting
Phase
Not Applicable
Locations
China
Study Type
Interventional
Intervention
1565nm Non-ablative Fractional Laser
5% minoxidil external use
1565nm Non-ablative Fractional Laser combined with 5% minoxidil
Sponsored by
Xijing Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Androgenic Alopecia focused on measuring 1565nm Non-ablative Fractional Laser, Androgenic Alopecia, Treatment

Eligibility Criteria

18 Years - 40 Years (Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria: 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. Exclusion Criteria: 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.

Sites / Locations

  • Dermatology Derpartment of Xijing HospitalRecruiting

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Active Comparator

Active Comparator

Arm Label

1565nm Non-ablative Fractional Laser

Minoxidil

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

Arm Description

1565nm Non-ablative Fractional Laser

Minoxidil for external use

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

Outcomes

Primary Outcome Measures

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.
BMI
weight and height will be combined to report BMI in kg/m^2

Secondary Outcome Measures

Full Information

First Posted
March 29, 2023
Last Updated
April 24, 2023
Sponsor
Xijing Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT05827991
Brief Title
A Clinical Observation of 1565nm Non-ablative Fractional Laser in the Treatment of Androgenic Alopecia
Official Title
A Randomized Controlled Trial of the Efficacy and Safety of 1565nm Non-ablative Fractional Laser on Treating Androgenic Alopecia
Study Type
Interventional

2. Study Status

Record Verification Date
January 2023
Overall Recruitment Status
Recruiting
Study Start Date
March 1, 2022 (Actual)
Primary Completion Date
December 31, 2023 (Anticipated)
Study Completion Date
December 31, 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Xijing Hospital

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No

5. Study Description

Brief Summary
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. 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Androgenic Alopecia
Keywords
1565nm Non-ablative Fractional Laser, Androgenic Alopecia, Treatment

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Crossover Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
75 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
1565nm Non-ablative Fractional Laser
Arm Type
Experimental
Arm Description
1565nm Non-ablative Fractional Laser
Arm Title
Minoxidil
Arm Type
Active Comparator
Arm Description
Minoxidil for external use
Arm Title
1565nm Non-ablative Fractional Laser combined with Minoxidil for external use
Arm Type
Active Comparator
Arm Description
1565nm Non-ablative Fractional Laser combined with Minoxidil for external use
Intervention Type
Device
Intervention Name(s)
1565nm Non-ablative Fractional Laser
Intervention Description
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
Drug
Intervention Name(s)
5% minoxidil external use
Intervention Description
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
Device
Intervention Name(s)
1565nm Non-ablative Fractional Laser combined with 5% minoxidil
Intervention Description
The two treatment mentioned above
Primary Outcome Measure Information:
Title
hair mirror
Description
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.
Time Frame
2 weeks
Title
BMI
Description
weight and height will be combined to report BMI in kg/m^2
Time Frame
2 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
40 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: 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. Exclusion Criteria: 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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Lin Gao, PhD
Phone
+8602984775401
Ext
029
Email
gaolin@fmmu.edu.cn
First Name & Middle Initial & Last Name or Official Title & Degree
Chen Yu, PhD
Phone
_8613571991903
Ext
029
Email
ycyc-2005@163.com
Facility Information:
Facility Name
Dermatology Derpartment of Xijing Hospital
City
Xi'an
State/Province
Shaanxi
ZIP/Postal Code
710032
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Gang Wang, prof
Phone
+8684775401
Email
xjwgang@fmmu.edu.cn

12. IPD Sharing Statement

Learn more about this trial

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

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