AzTrials
AzTrials

Androgenic AlopeciaNCT06292533

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

A study testing Er:YAG laser in people with Androgenic Alopecia and Alopecia, run by Universiti Tunku Abdul Rahman at 1 site in Malaysia.

Enrolling by invitation

Enrolling by invitation. The study team selects and invites participants, usually from an existing group of patients.

Sites and contacts
Official record
Search all trials

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. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Androgenic Alopecia, Alopecia
What is being tested?
Er:YAG laser
Type of treatment
Medical device
Could I receive a placebo?
No, everyone receives an active treatment
How many people
92 participants
Where
1 siteMalaysia
Study dates
1 Dec 2024to Dec 2025
Phase
Interventional
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

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

Who cannot join

  • 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

Trial locations and contacts

1 site in 1 country. Contact the study team or a site near you to ask about taking part.

Malaysia1 site

  • Hair Doc Puchong

    Bandar Puchong Jaya, Selangor, 47170

Other trials in Malaysia

About this 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.
Read the 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.

Being tested
Er:YAG laser
Keywords
Androgenic Alopecia, Alopecia treatment, Ultrapulse, Malaysian
Medical subject headings
Alopecia

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Er:YAG laserDevice

    Also called Ultrapulse

    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.

Study groups in NCT06292533
Study groupRoleWhat they receive
Intervention GroupExperimentalUltrapulse 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.
Receives: Device: Er:YAG laser
Control-waitlist GroupNo interventionParticipants 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 being measured

The primary outcome is the main question the study is designed to answer.

  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.

    Measured: 4 months

Secondary outcomes (3)

  1. 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).

    Measured: 4 months

  2. 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.

    Measured: 4 months

  3. 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.

    Measured: 4 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted5 Mar 2024
  2. Study start1 Dec 2024
  3. Primary completionAug 2025 (estimated)
  4. Study completionDec 2025 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Non-randomised
Intervention model
Parallel groups
Masking
Single blind
Who is masked
Outcomes assessor
Enrolment
92 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06292533
Sponsor's protocol ID
UTAR-30-2024
Status last verified
Dec 2024
First submitted
27 Feb 2024
Last updated
18 Dec 2024
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

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.

    PubMed 31321172

  • 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.

    PubMed 26885014

  • 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.

    PubMed 34435735

  • 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.

    PubMed 22879715

Questions about this trial

What is this clinical trial studying?

A study testing Er:YAG laser in people with Androgenic Alopecia and Alopecia, run by Universiti Tunku Abdul Rahman at 1 site in Malaysia.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 1 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: enrolling by invitation, as of the sponsor's last update on 18 Dec 2024. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Malaysia. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Global assessment of hair growth (time frame: 4 months). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT06292533, which also lists 4 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Dec 2024.

AzTrials uses cookies for analytics and advertising. You can accept or reject them; the site works either way. Privacy Policy.

Free account

Log in to keep searching

You’ve used your 3 free searches. AzTrials is free: log in or create a free account to keep searching clinical trials and save the ones you want to follow.

Create a free accountLog in