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Enrolling by invitation NCT06292533

Effectiveness of Ultrapulse for the Treatment of Androgenic Alopecia Among Malaysian: A Quasi-experimental Study

No phase Interventional Androgenic Alopecia Alopecia

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Er:YAG laser.
Who it may be relevant to
Registry conditions: Androgenic Alopecia, Alopecia. Basic parameters: from 18 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Malaysia
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Overview

The goal of this study is to to evaluate the effectiveness of Ultrapulse for the treatment of androgenic alopecia among Malaysian. The main questions it aims to answer are: * the efficacy of Ultrapulse in treatment of androgenic alopecia among Malaysian * the safety and adverse effect of Ultrapulse treatment. * the quality of life of androgenic alopecia among Malaysian.

Detailed description

Ultrapulse is a is a laser beauty device using erbium-doped yttrium aluminium garnet laser (er:YAG). Er:YAG laser is a laser with wavelength of 2940nm which is able to penetrate into the dermis to a depth of 3-4 mm, and energy absorption occurs in the area of the dermal papilla, resulting in an increase in blood circulation of the papilla and activation of metabolism in the hair follicle. It generates multiple micro pores at the epidermal layer that enhances the absorption of the active substances that help to stimulate hair growth developed by Lyzer Co. Ltd in Korea.

Interventions

  • Device Er:YAG laser
    Ultrapulse is a is a laser beauty device using erbium-doped yttrium aluminium garnet laser (er:YAG). Er:YAG laser is a laser with wavelength of 2940nm which is able to penetrate into the dermis to a depth of 3-4 mm, and energy absorption occurs in the area of the dermal papilla, resulting in an increase in blood circulation of the papilla and activation of metabolism in the hair follicle.

Primary outcome measures

  • Global assessment of hair growth [Time frame: 4 months]
Secondary outcome measures (3)
  • Patient satisfaction [Time frame: 4 months]
  • Quality of Life of Patient [Time frame: 4 months]
  • Adverse effects [Time frame: 4 months]

Eligibility criteria

Inclusion criteria

\- Patient with androgenic alopecia with severity of Norwood-Hamilton Scale II to VI for male and Ludwig Scale I to III for female

Exclusion criteria

  • Use of topical or systemic medications affecting hair growth within the 6 months before recruitment
  • Previous hair transplantation, underwent scalp reconstruction procedure, hair braiding or scalp tattoo

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
Non-randomized
Model
Parallel assignment
Masking
Single blind
Primary purpose
Treatment

Study locations

Malaysia · 1 center
  • Hair Doc Puchong — Bandar Puchong Jaya

Publications

  • Dabek RJ, Austen WG Jr, Bojovic B. Laser-assisted Hair Regrowth: Fractional Laser Modalities for the Treatment of Androgenic Alopecia. Plast Reconstr Surg Glob Open. 2019 Apr 11;7(4):e2157. doi: 10.1097/GOX.0000000000002157. eCollection 2019 Apr. PMID 31321172
  • Ke J, Guan H, Li S, Xu L, Zhang L, Yan Y. Erbium: YAG laser (2,940 nm) treatment stimulates hair growth through upregulating Wnt 10b and beta-catenin expression in C57BL/6 mice. Int J Clin Exp Med. 2015 Nov 15;8(11):20883-9. eCollection 2015. PMID 26885014
  • Day D, McCarthy M, Talaber I. Non-ablative Er:YAG laser is an effective tool in the treatment arsenal of androgenetic alopecia. J Cosmet Dermatol. 2022 May;21(5):2056-2063. doi: 10.1111/jocd.14370. Epub 2021 Aug 26. PMID 34435735
  • Han SH, Byun JW, Lee WS, Kang H, Kye YC, Kim KH, Kim DW, Kim MB, Kim SJ, Kim HO, Sim WY, Yoon TY, Huh CH, Hwang SS, Ro BI, Choi GS. Quality of life assessment in male patients with androgenetic alopecia: result of a prospective, multicenter study. Ann Dermatol. 2012 Aug;24(3):311-8. doi: 10.5021/ad.2012.24.3.311. Epub 2012 Jul 25. PMID 22879715

Identifiers

NCT: NCT06292533 · UTAR-30-2024

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗