Androgenic AlopeciaNCT05827991
A Clinical Observation of 1565nm Non-ablative Fractional Laser in the Treatment of Androgenic Alopecia
A study testing 1565nm Non-ablative Fractional Laser, 5% minoxidil external use and 1565nm Non-ablative Fractional Laser combined with 5% minoxidil in people with Androgenic Alopecia, run by Xijing Hospital at 1 site in China.
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%. Read more about this study
- Who is it for?
- Ages 18 to 40 years
- Conditions the study is for
- Androgenic Alopecia
- What is being tested?
- 1565nm Non-ablative Fractional Laser, 5% minoxidil external use and 1565nm Non-ablative Fractional Laser combined with 5% minoxidil
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 75 participants
- Where
- 1 siteChina
- Study dates
- 1 Mar 2022to 31 Dec 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 40 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- 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.
Who cannot join
- 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;
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- Pregnant or nursing;
- Recent skin infections (such as viruses and bacteria);
- Those who cannot persist in treatment and follow-up.
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
Dermatology Derpartment of Xijing Hospital
Xi'an, Shaanxi, 710032
Gang Wang, prof, +8684775401, xjwgang@fmmu.edu.cn
About this study
Official title: A Randomized Controlled Trial of the Efficacy and Safety of 1565nm Non-ablative Fractional Laser on Treating Androgenic Alopecia
- 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.
- Conditions
- Androgenic Alopecia
- Being tested
- 1565nm Non-ablative Fractional Laser, 5% minoxidil external use, 1565nm Non-ablative Fractional Laser combined with 5% minoxidil
- Keywords
- 1565nm Non-ablative Fractional Laser, Androgenic Alopecia, Treatment
- Medical subject headings
- Alopecia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
1565nm Non-ablative Fractional LaserDevice
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.
5% minoxidil external useDrug
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 5% minoxidilDevice
The two treatment mentioned above
| Study group | Role | What they receive |
|---|---|---|
| 1565nm Non-ablative Fractional Laser | Experimental | 1565nm Non-ablative Fractional Laser Receives: Device: 1565nm Non-ablative Fractional Laser |
| Minoxidil | Active comparator | Minoxidil for external use Receives: 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 Receives: Device: 1565nm Non-ablative Fractional Laser combined with 5% minoxidil |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 2 weeks
BMI
weight and height will be combined to report BMI in kg/m^2
Measured: 2 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Apr 2023
- Study start1 Mar 2022
- Primary completion31 Dec 2023 (estimated)
- Study completion31 Dec 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Androgenic AlopeciaStudies of the same condition, open and under way.
- More trials run by Xijing HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 75 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Xijing Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05827991
- Sponsor's protocol ID
- XijingH-PF-KY20222044-F-1
- Status last verified
- Jan 2023
- First submitted
- 29 Mar 2023
- Last updated
- 25 Apr 2023
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 25 Apr 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized Controlled Trial of the Efficacy and Safety of 1565nm Non-ablative Fractional Laser on Treating Androgenic Alopecia
- ClinicalTrials.gov ID
- NCT05827991
- Acronym / sponsor ID
- XijingH-PF-KY20222044-F-1
- Conditions
- Androgenic Alopecia
- Keywords
- 1565nm Non-ablative Fractional Laser, Androgenic Alopecia, Treatment
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 75 participants (estimated)
- Lead sponsor
- Xijing HospitalUniversity, hospital or other
- Study start
- 1 Mar 2022 (actual)
- Primary completion
- 31 Dec 2023 (estimated)
- Study completion
- 31 Dec 2023 (estimated)
- First posted
- 25 Apr 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
- 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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| 1565nm Non-ablative Fractional Laser | Experimental | Device: 1565nm Non-ablative Fractional Laser1565nm Non-ablative Fractional Laser |
| Minoxidil | Active comparator | Drug: 5% minoxidil external useMinoxidil for external use |
| 1565nm Non-ablative Fractional Laser combined with Minoxidil for external use | Active comparator | Device: 1565nm Non-ablative Fractional Laser combined with 5% minoxidil1565nm Non-ablative Fractional Laser combined with Minoxidil for external use |
Who may qualify
- Ages
- 18 to 40 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (9 listed)
- 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;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 1565nm Non-ablative Fractional Laser1565nm 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. | Device | 1565nm Non-ablative Fractional Laser |
| 5% minoxidil external useThe method of use of 5% minoxidil tincture is for topical use on the scalp, 1 ml per time, 2 times per day. | Drug | Minoxidil |
| 1565nm Non-ablative Fractional Laser combined with 5% minoxidilThe two treatment mentioned above | Device | 1565nm Non-ablative Fractional Laser combined with Minoxidil for external use |
Primary outcome
hair mirror
Time frame: 2 weeks
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
Time frame: 2 weeks
weight and height will be combined to report BMI in kg/m^2
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Apr 2023.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing 1565nm Non-ablative Fractional Laser, 5% minoxidil external use and 1565nm Non-ablative Fractional Laser combined with 5% minoxidil in people with Androgenic Alopecia, run by Xijing Hospital at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 25 Apr 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Lin Gao, PhD (+8602984775401 ext. 029, gaolin@fmmu.edu.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
hair mirror (time frame: 2 weeks). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 25 Apr 2023.