Clinical trial NCT06292533: Effectiveness of Ultrapulse for the Treatment of Androgenic Alopecia Among Malaysian: A Quasi-experimental Study
Official title: Effectiveness of Ultrapulse for the Treatment of Androgenic Alopecia Among Malaysian: A Quasi-experimental Study
Study type: INTERVENTIONAL
Overall status: ENROLLING_BY_INVITATION
Phase: NA
Conditions: Androgenic Alopecia
Alopecia
Keywords: Androgenic Alopecia
Alopecia treatment
Ultrapulse
Malaysian
Lead sponsor: Universiti Tunku Abdul Rahman
Sponsor class: OTHER
First posted: 2024-03-05
Enrollment: 92
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: 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.

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

Primary outcomes:
measure: Global assessment of hair growth
timeFrame: 4 months
Secondary outcomes:
measure: Patient satisfaction
timeFrame: 4 months
measure: Quality of Life of Patient
timeFrame: 4 months
measure: Adverse effects
timeFrame: 4 months
Other outcomes:
Locations:
city: Bandar Puchong Jaya
country: Malaysia
facility: Hair Doc Puchong
state: Selangor
Study officials:
affiliation: Universiti Tunku Abdul Rahman
name: Yang Mooi Lim, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: 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.
citation: 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.
citation: 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.