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

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Zhejiang University

Status

Enrolling

Conditions

Androgenetic Alopecia

Treatments

Drug: 5% Minoxidil
Device: non-ablative fractional 1565nm
Device: ablative fractional 2940-nm Er: YAG laser

Study type

Interventional

Funder types

Other

Identifiers

NCT06218498
20230943

Details and patient eligibility

About

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).

Full 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.

Enrollment

135 estimated patients

Sex

Male

Ages

18 to 65 years old

Volunteers

No Healthy Volunteers

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

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Single Blind

135 participants in 3 patient groups

ablative fractional 2940-nm erbium yttrium aluminum garnet (Er: YAG) laser
Experimental group
Treatment:
Device: ablative fractional 2940-nm Er: YAG laser
non-ablative fractional 1565nm
Experimental group
Treatment:
Device: non-ablative fractional 1565nm
5% minoxidil
Active Comparator group
Treatment:
Drug: 5% Minoxidil

Trial contacts and locations

1

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Central trial contact

Ru Dai, M.D; Ru Dai

Data sourced from clinicaltrials.gov

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