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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT06218498
Other study ID # 20230943
Secondary ID
Status Recruiting
Phase N/A
First received
Last updated
Start date November 24, 2023
Est. completion date December 31, 2024

Study information

Verified date November 2023
Source Second Affiliated Hospital, School of Medicine, Zhejiang University
Contact Ru Dai
Phone +8615982215914
Email dairu@zju.edu.cn
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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).


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.


Recruitment information / eligibility

Status Recruiting
Enrollment 135
Est. completion date December 31, 2024
Est. primary completion date June 30, 2024
Accepts healthy volunteers No
Gender Male
Age group 18 Years to 65 Years
Eligibility 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


Related Conditions & MeSH terms


Intervention

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.
non-ablative fractional 1565nm
Non-ablative fractional 1565nm (Lumenis, M22): Resur Fx len, energy of 30-35J/cm2, density of 200spot/cm2, overlap =10%.
Drug:
5% Minoxidil
topical 5% minoxidil, 1 ml, twice daily

Locations

Country Name City State
China Second Affiliated Hospital, School of Medicine, Zhejiang University, China Hangzhou Zhejiang

Sponsors (1)

Lead Sponsor Collaborator
Second Affiliated Hospital, School of Medicine, Zhejiang University

Country where clinical trial is conducted

China, 

Outcome

Type Measure Description Time frame Safety issue
Other Incidents of adverse events Safety assessment through study completion, an average of 36 weeks
Primary TAHC Use the trichoscopy to assess the changing number of non-vellus hairs in the target area . week 24
Secondary HGQA Hair growth questionnaire assessment week 8, week 12, week 16, week 24, week 36
Secondary 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
Secondary 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
Secondary 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
Secondary Grade of Norwood-Hamilton The Grade of Norwood-Hamilton Classification week 12, week 24, week 36
Secondary 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
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