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

Not Applicable

Recruiting

• Conditions: Androgenetic Alopecia
• Interventions: Drug: 5% Minoxidil; Device: non-ablative fractional 1565nm

• Registration Number: NCT06218498
• Lead Sponsor: Second Affiliated Hospital, School of Medicine, Zhejiang University

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.

Study Timeline

• Status Verified: 2023-11
• Study Start: 2023-11-24
• Study First Submitted: 2024-01-02
• Study First Submitted QC: 2024-01-21
• Last Update Submitted: 2024-01-21
• Study First Posted: 2024-01-23
• Last Update Posted: 2024-01-23
• Primary Completion: 2024-06-30
• Study Completion: 2024-12-31

Recruitment & Eligibility

• Status: RECRUITING
• Sex: Male
• Target Recruitment: 135

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
5% minoxidil	5% Minoxidil	-
non-ablative fractional 1565nm	non-ablative fractional 1565nm	-

Primary Outcome Measures

Name	Time	Method
TAHC	week 24	Use the trichoscopy to assess the changing number of non-vellus hairs in the target area .

Secondary Outcome Measures

Name	Time	Method
IGA	week 8, week 12, week 16, week 24, week 36	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.
Grade of Norwood-Hamilton	week 12, week 24, week 36	The Grade of Norwood-Hamilton Classification
HGQA	week 8, week 12, week 16, week 24, week 36	Hair growth questionnaire assessment
TAHC	week 8, week 12, week 20, week 36	Use the trichoscopy to assess the changing number of non-vellus hairs in the target area
TAHW	week 8, week 12, week 16, week 24, week 36	Use the trichoscopy to assess the changing diameter of non-vellus hairs in the target area
SSA	week 8, week 12, week 16, week 24, week 36	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.

Trial Locations

Locations (1)

Second Affiliated Hospital, School of Medicine, Zhejiang University, China; 🇨🇳 Hangzhou, Zhejiang, China