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

Alopecia Clinical Trial

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT06292533
• Other study ID #: UTAR-30-2024
• Status: Not yet recruiting
• Phase: N/A
• Start date: March 2024
• Est. completion date: October 2024

Study information

• Verified date: February 2024
• Source: Universiti Tunku Abdul Rahman
• Contact: Yang Mooi Lim, PhD
• Phone: 60390860288
• Email: ymlim[@]utar.edu.my
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 92
• Est. completion date: October 2024
• Est. primary completion date: October 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Alopecia
• Alopecia Areata
• Androgenic Alopecia

Intervention

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.

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Universiti Tunku Abdul Rahman

References & Publications (4)

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. — View 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. — View 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. — View 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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
Secondary	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
Secondary	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