Clinical trial NCT06218498: Comparison of an Non-ablative Fractional 1565nm vs. an Ablative 2940-nm Fractional Er Laser for the Treatment of Androgenetic Alopecia
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
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Androgenetic Alopecia
Lead sponsor: Second Affiliated Hospital, School of Medicine, Zhejiang University
Sponsor class: OTHER
First posted: 2024-01-23
Enrollment: 135
Sex: MALE
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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).

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.

Eligibility criteria: 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

Primary outcomes:
measure: TAHC
timeFrame: week 24
Secondary outcomes:
measure: HGQA
timeFrame: week 8, week 12, week 16, week 24, week 36
measure: TAHC
timeFrame: week 8, week 12, week 20, week 36
measure: TAHW
timeFrame: week 8, week 12, week 16, week 24, week 36
measure: IGA
timeFrame: week 8, week 12, week 16, week 24, week 36
measure: Grade of Norwood-Hamilton
timeFrame: week 12, week 24, week 36
measure: SSA
timeFrame: week 8, week 12, week 16, week 24, week 36
Other outcomes:
measure: Incidents of adverse events
timeFrame: through study completion, an average of 36 weeks
Locations:
city: Hangzhou
country: China
facility: Second Affiliated Hospital, School of Medicine, Zhejiang University, China
state: Zhejiang
Study officials:
affiliation: Second Affiliated Hospital, School of Medicine, Zhejiang University
name: Xianjie Wu, Ph.D
role: PRINCIPAL_INVESTIGATOR
References: