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

NCT ID: NCT06292533

Last Updated: 2024-12-18

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

ENROLLING_BY_INVITATION

Clinical Phase

NA

Total Enrollment

92 participants

Study Classification

INTERVENTIONAL

Study Start Date

2024-12-01

Study Completion Date

2025-12-31

Brief Summary

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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

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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.

Conditions

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Androgenic Alopecia Alopecia

Keywords

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Androgenic Alopecia Alopecia treatment Ultrapulse Malaysian

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Outcome Assessors

Study Groups

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Intervention Group

Ultrapulse treatment will be delivered by trained beautician for 6 sessions with 2 weeks interval. After the last session, participants will then follow up every 2 weeks for 1 month.

Group Type EXPERIMENTAL

Er:YAG laser

Intervention Type DEVICE

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.

Control-waitlist Group

Participants in control-waitlist group will receive homecare treatment that does not interfere with hair growth for 6 sessions with 2 weeks interval, follow up every 2 weeks for 1 month after last session and receive Ultrapulse treatment after the research end.

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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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.

Intervention Type DEVICE

Other Intervention Names

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Ultrapulse

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Universiti Tunku Abdul Rahman

OTHER

Sponsor Role lead

Responsible Party

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Yang Mooi Lim

Director (Institute of Postgraduate Studies and Research), Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Yang Mooi Lim, PhD

Role: PRINCIPAL_INVESTIGATOR

Universiti Tunku Abdul Rahman

Locations

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Hair Doc Puchong

Bandar Puchong Jaya, Selangor, Malaysia

Site Status

Countries

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Malaysia

References

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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.

Reference Type BACKGROUND
PMID: 31321172 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 26885014 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 34435735 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 22879715 (View on PubMed)

Other Identifiers

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UTAR-30-2024

Identifier Type: -

Identifier Source: org_study_id