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

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).

Study Overview

• Status: Recruiting
• Conditions: Androgenetic Alopecia
• Intervention / Treatment: Device: ablative fractional 2940-nm Er: YAG laser; Device: non-ablative fractional 1565nm; Drug: 5% Minoxidil

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 Type: Interventional
• Enrollment (Estimated): 135
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Ru Dai; Phone Number: +8615982215914; Email: dairu@zju.edu.cn
• Study Contact Backup: Name: Ru Dai, M.D; Phone Number: +8615982215914; Email: dairu@zju.edu.cn

Study Locations

• China
  • Zhejiang
    • Hangzhou, Zhejiang, China, 310009
      • Recruiting
      • Second Affiliated Hospital, School of Medicine, Zhejiang University, China
      • Contact: Ru Dai, Ph.D; Phone Number: 86 15982215914; Email: dairu@zju.edu.cn

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: ablative fractional 2940-nm erbium yttrium aluminum garnet (Er: YAG) laser	Device: 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.
Experimental: non-ablative fractional 1565nm	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%.
Active Comparator: 5% minoxidil	Drug: 5% Minoxidil; topical 5% minoxidil, 1 ml, twice daily

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
TAHC	Use the trichoscopy to assess the changing number of non-vellus hairs in the target area .	week 24

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
HGQA	Hair growth questionnaire assessment	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	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	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.	week 8, week 12, week 16, week 24, week 36
Grade of Norwood-Hamilton	The Grade of Norwood-Hamilton Classification	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.	week 8, week 12, week 16, week 24, week 36

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Incidents of adverse events	Safety assessment	through study completion, an average of 36 weeks

Collaborators and Investigators

• Sponsor: Second Affiliated Hospital, School of Medicine, Zhejiang University
• Investigators: Principal Investigator: Xianjie Wu, Ph.D, Second Affiliated Hospital, School of Medicine, Zhejiang University

Study record dates

Study Major Dates

• Study Start (Actual): November 24, 2023
• Primary Completion (Estimated): June 30, 2024
• Study Completion (Estimated): December 31, 2024

Study Registration Dates

• First Submitted: January 2, 2024
• First Submitted That Met QC Criteria: January 21, 2024
• First Posted (Actual): January 23, 2024

Study Record Updates

• Last Update Posted (Actual): January 23, 2024
• Last Update Submitted That Met QC Criteria: January 21, 2024
• Last Verified: November 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Skin Diseases; Pathological Conditions, Anatomical; Hypotrichosis; Hair Diseases; Alopecia; Alopecia Areata; Antihypertensive Agents; Vasodilator Agents; Minoxidil
• Other Study ID Numbers: 20230943

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO
• IPD Plan Description: 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.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No