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

Androgenetic Alopecia Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06218498
• Other study ID #: 20230943
• Status: Recruiting
• Phase: N/A
• 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
• 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

Related Conditions & MeSH terms

• Alopecia
• Alopecia Areata
• Androgenetic Alopecia

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