Clinical Trials Logo

Clinical Trial Details — Status: Not yet recruiting

Administrative data

NCT number NCT06292533
Other study ID # UTAR-30-2024
Secondary ID
Status Not yet recruiting
Phase N/A
First received
Last updated
Start date June 2024
Est. completion date October 2024

Study information

Verified date May 2024
Source Universiti Tunku Abdul Rahman
Contact Yang Mooi Lim, PhD
Phone 60390860288
Email ymlim@utar.edu.my
Is FDA regulated No
Health authority
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

Study Design


Related Conditions & MeSH terms


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
See also
  Status Clinical Trial Phase
Active, not recruiting NCT04953416 - Fractional Non-ablative Laser for the Treatment of Hair Loss N/A
Completed NCT01929330 - Bioequivalence Study of Dutasteride Five 0.1 mg and One 0.5 mg Soft Gelatin Capsules in Healthy Male Volunteers Phase 1
Recruiting NCT05213936 - Scalp Cooling for Chemotherapy-Induced Alopecia in Patients of Color N/A
Completed NCT02919735 - Efficacy, Safety and Tolerability of CG428 Cutaneous Solution on Chemotherapy Induced Alopecia; Controlled Study (ELAN) Phase 2
Recruiting NCT02591823 - Hair Fall in Patients on Low Dose Methotrexate N/A
Enrolling by invitation NCT01651689 - Hair Counts From Vertical and Horizontal Sections of Scalp Biopsy SPecimens in Thai Population With Alopecia N/A
Completed NCT01189279 - Safety and Pharmacokinetics Study of New Formulation of Bimatoprost in Patients With Alopecia Phase 1
Recruiting NCT01111981 - Safety and Efficacy of Clobetasol Propionate 0.05% E Foam in Alopecia Phase 4
Terminated NCT01385839 - Efficacy of Hair Transplantation Compared With Hypodermic Needle Irritation in Alopecia Areata N/A
Active, not recruiting NCT03382184 - Fractional Photothermolysis for Hair Follicle Induction Early Phase 1
Not yet recruiting NCT05544448 - In Vitro Effect Study of Interleukin-2 Muteins on Regulatory T Cells of Patients With Different Autoimmune, Allo-immune or Inflammatory Diseases N/A
Completed NCT03689452 - The Effect of Platelet Rich Plasma on Non-scarring Alopecia N/A
Completed NCT06409650 - To Evaluate Safety and Efficacy of KX-826 in Chinese Female Subjects With Androgenetic Alopecia Phase 2
Recruiting NCT00801086 - Efficacy Study of Tempol to Prevent Hair Loss From Radiotherapy to the Brain Phase 2
Completed NCT06095739 - Study to Investigate the Effectiveness of a Topical Cosmetic Formulation DA-OTC-002 N/A
Completed NCT05587699 - The Parallel Study to Evaluate the Pharmacokinetics, Pharmacodynamics, and Safety of CKD-843 A Phase 1
Completed NCT03351322 - ENERGI-F701 for Female Hair Loss Treatment Phase 2
Terminated NCT02935569 - Compression Headband Use to Prevent Hair Loss During Whole Brain Radiotherapy N/A
Completed NCT01590238 - Enhancing Hair Density With Platelet Rich Fibrin Matrix (PRFM) Phase 3
Not yet recruiting NCT01557491 - Hair Regrowth After Bicoronal Incision N/A