Androgenetic AlopeciaNCT06218498
Comparison of an Non-ablative Fractional 1565nm vs. an Ablative 2940-nm Fractional Er Laser for the Treatment of Androgenetic Alopecia
A study testing ablative fractional 2940-nm Er: YAG laser, non-ablative fractional 1565nm and 5% Minoxidil in people with Androgenetic Alopecia, run by Second Affiliated Hospital, Zhejiang University, School of Medicine at 1 site in China.
Trial summary
Laser sources have established their potential effect in inducing hair regrowth. No study has compared the effect of ablative fractional 2940-nm erbium yttrium aluminum garnet (Er: YAG) laser and non-fractional 15650nm fractional laser in the treatment of androgenetic alopecia (AGA). Read more about this study
- Who is it for?
- Ages 18 to 65 years, men only
- Conditions the study is for
- Androgenetic Alopecia
- What is being tested?
- ablative fractional 2940-nm Er: YAG laser, non-ablative fractional 1565nm and 5% Minoxidil
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 135 participants
- Where
- 1 siteChina
- Study dates
- 24 Nov 2023to 31 Dec 2024
- 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 65 years
- Men only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- age between 18 and 65 years;；
- clinical diagnosis of AGA；
- AGA diagnosis was evaluated following Norwood Hamilton grade II-V criteria；
- no previous laser treatments for AGA in the past six months before enrollment；
- willingness to provide pictures and follow-up studies.
Who cannot join
- if presented with severe diseases of internal organs, eyes, or skin;
- inflammation, infection, or unhealed wounds on the skin around the site of treatment on the head;
- systematic treatment with corticosteroids or other immunosuppressants and immunomodulators in the past 3 months
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
Second Affiliated Hospital, School of Medicine, Zhejiang University, China
Hangzhou, Zhejiang, 310009
Ru Dai, Ph.D, 86 15982215914, dairu@zju.edu.cn
About this study
Official title: Comparison of an Non-ablative Fractional 1565nm vs. an Ablative 2940-nm Fractional Erbium-glass Laser for the Treatment of Male Androgenetic Alopecia
Laser sources have established their potential effect in inducing hair regrowth. No study has compared the effect of ablative fractional 2940-nm erbium yttrium aluminum garnet (Er: YAG) laser and non-fractional 15650nm fractional laser in the treatment of androgenetic alopecia (AGA).
Read the detailed description
The investigators performed a prospective study between to compare the efficacy and safety of ablative fractional 2940-nm erbium yttrium aluminum garnet (Er: YAG) laser and non-fractional 15650nm fractional laser in the treatment of androgenetic alopecia (AGA). The efficacy of the two therapies was evaluated by the investigator's Global Assessment (IGA) scores and the patient's Likert satisfaction scale at week 12 and week 24. Changes in total, terminal and villous hair count, total and terminal hair diameter, and AGA grade were also recorded. Adverse events were evaluated at each follow-up.
- Conditions
- Androgenetic Alopecia
- Being tested
- ablative fractional 2940-nm Er: YAG laser, non-ablative fractional 1565nm, 5% Minoxidil
- Medical subject headings
- Alopecia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ablative fractional 2940-nm Er: YAG laserDevice
Ablative fractional 2940-nm Er: YAG laser (Dermablate MCL31, Asclepion Laser Technologies, Germany), the following parameters were used: model of N25%, energy density of 20-30J/cm2, pulse time of 300μs and one to two passes.
non-ablative fractional 1565nmDevice
Non-ablative fractional 1565nm (Lumenis, M22): Resur Fx len, energy of 30-35J/cm2, density of 200spot/cm2, overlap ≤10%.
5% MinoxidilDrug
topical 5% minoxidil, 1 ml, twice daily
| Study group | Role | What they receive |
|---|---|---|
| ablative fractional 2940-nm erbium yttrium aluminum garnet (Er: YAG) laser | Experimental | Not described Receives: Device: ablative fractional 2940-nm Er: YAG laser |
| non-ablative fractional 1565nm | Experimental | Not described Receives: Device: non-ablative fractional 1565nm |
| 5% minoxidil | Active comparator | Not described Receives: Drug: 5% Minoxidil |
What is being measured
The primary outcome is the main question the study is designed to answer.
TAHC
Use the trichoscopy to assess the changing number of non-vellus hairs in the target area .
Measured: week 24
Secondary outcomes (6)
HGQA
Hair growth questionnaire assessment
Measured: week 8, week 12, week 16, week 24, week 36
TAHC
Use the trichoscopy to assess the changing number of non-vellus hairs in the target area
Measured: week 8, week 12, week 20, week 36
TAHW
Use the trichoscopy to assess the changing diameter of non-vellus hairs in the target area
Measured: week 8, week 12, week 16, week 24, week 36
IGA
Investigator's Global Assessment. IGA was evaluated using a 7-point scale as follows: -3= obvious reduction of hair; -2= moderate reduction of hair; -1= mild reduction of hair; 0= change; 1= mild growth of hair; 2= moderate growth of hair; 3= obvious growth of hair.
Measured: week 8, week 12, week 16, week 24, week 36
Grade of Norwood-Hamilton
The Grade of Norwood-Hamilton Classification
Measured: week 12, week 24, week 36
SSA
Subject self-assessment. SSA was evaluated using a 7-point scale as follows: -3= obvious reduction of hair; -2= moderate reduction of hair; -1= mild reduction of hair; 0= change; 1= mild growth of hair; 2= moderate growth of hair; 3= obvious growth of hair.
Measured: week 8, week 12, week 16, week 24, week 36
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Jan 2024
- Study start24 Nov 2023
- Primary completion30 Jun 2024 (estimated)
- Study completion31 Dec 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Androgenetic AlopeciaStudies of the same condition, open and under way.
- More trials run by Second Affiliated Hospital, Zhejiang University, School of MedicineThe 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
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 135 participants (estimated)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Xianjie Wu, Ph.D, Principal investigator, Second Affiliated Hospital, Zhejiang University, School of Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06218498
- Sponsor's protocol ID
- 20230943
- Status last verified
- Nov 2023
- First submitted
- 2 Jan 2024
- Last updated
- 23 Jan 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: The data that support the findings of this study are not publicly available due to the privacy of research participants but are available from the sponsor upon reasonable request.
Study at a glance
From the registry record, last updated by the sponsor on 23 Jan 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of an Non-ablative Fractional 1565nm vs. an Ablative 2940-nm Fractional Erbium-glass Laser for the Treatment of Male Androgenetic Alopecia
- ClinicalTrials.gov ID
- NCT06218498
- Acronym / sponsor ID
- 20230943
- Conditions
- Androgenetic Alopecia
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 135 participants (estimated)
- Lead sponsor
- Second Affiliated Hospital, Zhejiang University, School of MedicineUniversity, hospital or other
- Study start
- 24 Nov 2023 (actual)
- Primary completion
- 30 Jun 2024 (estimated)
- Study completion
- 31 Dec 2024 (estimated)
- First posted
- 23 Jan 2024 (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.
Laser sources have established their potential effect in inducing hair regrowth. No study has compared the effect of ablative fractional 2940-nm erbium yttrium aluminum garnet (Er: YAG) laser and non-fractional 15650nm fractional laser in the treatment of androgenetic alopecia (AGA).
Detailed description
The investigators performed a prospective study between to compare the efficacy and safety of ablative fractional 2940-nm erbium yttrium aluminum garnet (Er: YAG) laser and non-fractional 15650nm fractional laser in the treatment of androgenetic alopecia (AGA). The efficacy of the two therapies was evaluated by the investigator's Global Assessment (IGA) scores and the patient's Likert satisfaction scale at week 12 and week 24. Changes in total, terminal and villous hair count, total and terminal hair diameter, and AGA grade were also recorded. Adverse events were evaluated at each follow-up.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| ablative fractional 2940-nm erbium yttrium aluminum garnet (Er: YAG) laser | Experimental | Device: ablative fractional 2940-nm Er: YAG laser |
| non-ablative fractional 1565nm | Experimental | Device: non-ablative fractional 1565nm |
| 5% minoxidil | Active comparator | Drug: 5% Minoxidil |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- age between 18 and 65 years;；
- clinical diagnosis of AGA；
- AGA diagnosis was evaluated following Norwood Hamilton grade II-V criteria；
- no previous laser treatments for AGA in the past six months before enrollment；
- willingness to provide pictures and follow-up studies.
Key exclusion criteria (3 listed)
- if presented with severe diseases of internal organs, eyes, or skin;
- inflammation, infection, or unhealed wounds on the skin around the site of treatment on the head;
- systematic treatment with corticosteroids or other immunosuppressants and immunomodulators in the past 3 months
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 |
|---|---|---|
| ablative fractional 2940-nm Er: YAG laserAblative fractional 2940-nm Er: YAG laser (Dermablate MCL31, Asclepion Laser Technologies, Germany), the following parameters were used: model of N25%, energy density of 20-30J/cm2, pulse time of 300μs and one to two passes. | Device | ablative fractional 2940-nm erbium yttrium aluminum garnet (Er: YAG) laser |
| non-ablative fractional 1565nmNon-ablative fractional 1565nm (Lumenis, M22): Resur Fx len, energy of 30-35J/cm2, density of 200spot/cm2, overlap ≤10%. | Device | non-ablative fractional 1565nm |
| 5% Minoxidiltopical 5% minoxidil, 1 ml, twice daily | Drug | 5% minoxidil |
Primary outcome
TAHC
Time frame: week 24
Use the trichoscopy to assess the changing number of non-vellus hairs in the target area .
6 secondary outcomes
HGQA
Time frame: week 8, week 12, week 16, week 24, week 36
TAHC
Time frame: week 8, week 12, week 20, week 36
TAHW
Time frame: week 8, week 12, week 16, week 24, week 36
IGA
Time frame: week 8, week 12, week 16, week 24, week 36
Grade of Norwood-Hamilton
Time frame: week 12, week 24, week 36
SSA
Time frame: week 8, week 12, week 16, week 24, week 36
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Jan 2024.
- Individual participant dataSharing planned: No. The data that support the findings of this study are not publicly available due to the privacy of research participants but are available from the sponsor upon reasonable request.
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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.
Xianjie Wu, Ph.D principal investigator
Second Affiliated Hospital, Zhejiang University, School of Medicine
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing ablative fractional 2940-nm Er: YAG laser, non-ablative fractional 1565nm and 5% Minoxidil in people with Androgenetic Alopecia, run by Second Affiliated Hospital, Zhejiang University, School of Medicine 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 5 inclusion and 3 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 23 Jan 2024. 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 Ru Dai (+8615982215914, dairu@zju.edu.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
TAHC (time frame: week 24). 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 23 Jan 2024.