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

NCT06218498 | Unknown

• 1 other identifier: 20230943
• Study Type: interventional
• Target: 135
• Locations: 1 country
• Sites: 1

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).

Conditions

Androgenetic Alopecia

Outcome Measures

Primary Outcomes (1)

• TAHC

  Use the trichoscopy to assess the changing number of non-vellus hairs in the target area .

  week 24

Secondary Outcomes (6)

• HGQA

  week 8, week 12, week 16, week 24, week 36

• TAHC

  week 8, week 12, week 20, week 36

• TAHW

  week 8, week 12, week 16, week 24, week 36

• IGA

  week 8, week 12, week 16, week 24, week 36

• Grade of Norwood-Hamilton

  week 12, week 24, week 36

Other Outcomes (1)

• Incidents of adverse events

  through study completion, an average of 36 weeks

Study Arms (3)

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

Interventions

ablative fractional 2940-nm Er: YAG laser 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.

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

non-ablative fractional 1565nm DEVICE

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

non-ablative fractional 1565nm

5% Minoxidil DRUG

topical 5% minoxidil, 1 ml, twice daily

5% minoxidil

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: male
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Second Affiliated Hospital, School of Medicine, Zhejiang University: lead

Study Sites (1)

Second Affiliated Hospital, School of Medicine, Zhejiang University, China

Hangzhou, Zhejiang, 310009, China

RECRUITING

MeSH Terms

Conditions

Alopecia

Interventions

Lasers, Solid-State; Minoxidil

Condition Hierarchy (Ancestors)

Hypotrichosis; Hair Diseases; Skin Diseases; Skin and Connective Tissue Diseases; Pathological Conditions, Anatomical; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Lasers; Optical Devices; Equipment and Supplies; Radiation Equipment and Supplies; Piperidines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Pyrimidines

Study Officials

• Xianjie Wu, Ph.D

  Second Affiliated Hospital, School of Medicine, Zhejiang University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Ru Dai

CONTACT

+8615982215914; dairu@zju.edu.cn

Ru Dai, M.D

CONTACT

+8615982215914; dairu@zju.edu.cn

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 2, 2024
• First Posted: January 23, 2024
• Study Start: November 24, 2023
• Primary Completion: June 30, 2024
• Study Completion: December 31, 2024
• Last Updated: January 23, 2024

Record last verified: 2023-11

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)