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

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.

Study Overview

• Status: Enrolling by invitation
• Conditions: Alopecia; Androgenic Alopecia
• Intervention / Treatment: Device: Er:YAG laser

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.

• Study Type: Interventional
• Enrollment (Estimated): 92
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Malaysia
  • Selangor
    • Bandar Puchong Jaya, Selangor, Malaysia, 47170
      • Hair Doc Puchong

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Non-Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: 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.	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.; Other Names: Ultrapulse
No Intervention: 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Global assessment of hair growth	Hair loss index will be recorded in the map and chart provided Cohen Hair Loss Classification System. The hair loss is scored with a single value from 1 to 100 to represent the percentage of hair of the patient's scalp. Global photography of the participant's scalp will be taken during first visit (baseline), immediate post-treatment (6 treatments), 2 weeks post-treatment and 1 month post-treatment. The evaluator will be responsible for scoring the hair loss index based on the global photograph provided.	4 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Patient satisfaction	The patient satisfaction of the participants in both intervention and control-waitlist group will be assessed during first visit (baseline), immediate post-treatment (6 treatments), 2 weeks post-treatment and 1 month post-treatment. by using SAPS questionnaire. It is scored by 0 (extremely dissatisfied) to 28 (extremely satisfied).	4 months
Quality of Life of Patient	The Hair specific Skindex-29 questionnaire comprised three types of scales: a symptom scale (7 items), a function scale (12 items), and an emotion scale (10 items). It is rated each question on a scale from 0 (never bothered) to 5 (always bothered). Responses for each item were converted to a linear scale, ranging from 0 (never bothered) to 100 (always bothered). A scale score represented the average score of the answered items, while a global score was the mean of the sums of each scale. A high score indicated a significantly impaired quality of life, whereas a low score indicated a mild impact on quality of life. The quality of life of the participants in both intervention and control-waitlist group will be assessed during first visit (baseline), immediate post-treatment (6 treatments), 2 weeks post-treatment and 1 month post-treatment.	4 months
Adverse effects	The adverse effects of the treatment will be recorded in the table in the provided sheet with the severity of 0 (no effect) to 3 (severe) except for pain using the visual analog scale from 0 (no pain) to 10 (extreme pain). The adverse effects will be recorded before and after participant received every treatment and during follow up.	4 months

Collaborators and Investigators

• Sponsor: Universiti Tunku Abdul Rahman
• Investigators: Principal Investigator: Yang Mooi Lim, PhD, Universiti Tunku Abdul Rahman

Publications and helpful links

General 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.
• 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.
• 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.
• 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.

Study record dates

Study Major Dates

• Study Start (Actual): December 1, 2024
• Primary Completion (Estimated): August 1, 2025
• Study Completion (Estimated): December 1, 2025

Study Registration Dates

• First Submitted: February 27, 2024
• First Submitted That Met QC Criteria: February 27, 2024
• First Posted (Actual): March 5, 2024

Study Record Updates

• Last Update Posted (Actual): March 25, 2025
• Last Update Submitted That Met QC Criteria: December 17, 2024
• Last Verified: December 1, 2024

More Information

Terms related to this study

• Keywords: Androgenic Alopecia; Alopecia treatment; Ultrapulse; Malaysian
• Additional Relevant MeSH Terms: Pathological Conditions, Anatomical; Skin Diseases; Hypotrichosis; Hair Diseases; Alopecia Areata; Alopecia
• Other Study ID Numbers: UTAR-30-2024

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No