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

NCT06292533 | Enrolling By Invitation DMC

• 1 other identifier: UTAR-30-2024
• Study Type: interventional
• Target: 92
• Locations: 1 country
• Sites: 1

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.

Conditions

Androgenic Alopecia; Alopecia

Keywords

Androgenic Alopecia; Alopecia treatment; Ultrapulse; Malaysian

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (3)

• Patient satisfaction

  4 months

• Quality of Life of Patient

  4 months

• Adverse effects

  4 months

Study Arms (2)

Intervention Group

EXPERIMENTAL

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

Control-waitlist Group

NO INTERVENTION

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.

Interventions

Er:YAG laser 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.

Also known as: Ultrapulse

Intervention Group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• Universiti Tunku Abdul Rahman: lead

Study Sites (1)

Hair Doc Puchong

Bandar Puchong Jaya, Selangor, 47170, Malaysia

Location

Related 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.

  PMID: 31321172 BACKGROUND

• 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 BACKGROUND

• 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 BACKGROUND

• 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 BACKGROUND

MeSH Terms

Conditions

Alopecia

Interventions

Lasers, Solid-State

Condition Hierarchy (Ancestors)

Hypotrichosis; Hair Diseases; Skin Diseases; Skin and Connective Tissue Diseases; Pathological Conditions, Anatomical; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Lasers; Optical Devices; Equipment and Supplies; Radiation Equipment and Supplies

Study Officials

• Yang Mooi Lim, PhD

  Universiti Tunku Abdul Rahman

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Director (Institute of Postgraduate Studies and Research), Professor

Study Record Dates

• First Submitted: February 27, 2024
• First Posted: March 5, 2024
• Study Start: December 1, 2024
• Primary Completion: August 1, 2025
• Study Completion: December 1, 2025
• Last Updated: December 18, 2024

Record last verified: 2024-12

Data Sharing

• IPD Sharing: Will not share

Locations

MY (1)