Comparison of an Non-ablative Fractional 1565nm vs. an Ablative 2940-nm Fractional Er Laser for the Treatment of Androgenetic Alopecia

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

NA

Total Enrollment

135 participants

Study Classification

INTERVENTIONAL

Study Start Date

2023-11-24

Study Completion Date

2024-12-31

Brief Summary

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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).

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Detailed Description

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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

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Androgenetic Alopecia

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Outcome Assessors

Study Groups

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ablative fractional 2940-nm erbium yttrium aluminum garnet (Er: YAG) laser

Group Type EXPERIMENTAL

ablative fractional 2940-nm Er: YAG laser

Intervention Type DEVICE

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 1565nm

Group Type EXPERIMENTAL

non-ablative fractional 1565nm

Intervention Type DEVICE

Non-ablative fractional 1565nm (Lumenis, M22): Resur Fx len, energy of 30-35J/cm2, density of 200spot/cm2, overlap ≤10%.

5% minoxidil

Group Type ACTIVE_COMPARATOR

5% Minoxidil

Intervention Type DRUG

topical 5% minoxidil, 1 ml, twice daily

Interventions

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ablative fractional 2940-nm Er: YAG laser

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.

Intervention Type DEVICE

non-ablative fractional 1565nm

Non-ablative fractional 1565nm (Lumenis, M22): Resur Fx len, energy of 30-35J/cm2, density of 200spot/cm2, overlap ≤10%.

Intervention Type DEVICE

5% Minoxidil

topical 5% minoxidil, 1 ml, twice daily

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* 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.

Exclusion Criteria

* 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

Minimum Eligible Age

18 Years

Maximum Eligible Age

65 Years

Eligible Sex

MALE

Accepts Healthy Volunteers

No