Skip to main content
OpenTrials
Enrolling by Invitation

NCT Number: NCT06292533

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.

Enrolling by Invitation

Interested in participating?

Request Info

Key information

Conditions

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

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Hair Doc Puchong

Bandar Puchong Jaya, Selangor, 47170, Malaysia

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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.

Other names: Ultrapulse

Primary outcomes

  1. Global assessment of hair growth

    Time frame: 4 months

    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.

Secondary outcomes

  1. Patient satisfaction

    Time frame: 4 months

    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).

  2. Quality of Life of Patient

    Time frame: 4 months

    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.

  3. Adverse effects

    Time frame: 4 months

    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.

Sponsors and collaborators

Lead sponsor

Universiti Tunku Abdul Rahman

Other

Registry information

Important dates

Study start
2024
Primary completion
2025
Study completion
2025
First posted
Mar 5, 2024
Registry last updated
Dec 18, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.