OneDoc Picopulse™ for the Treatment of Melasma Among Malaysian Women

Melanoma (Skin) Clinical Trial

Official title:

OneDoc Picopulse™ for the Treatment of Melasma Among Malaysian Women

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04834167
• Other study ID #: UTAR-45-2021
• Status: Completed
• Phase: N/A
• Start date: May 1, 2021
• Est. completion date: December 1, 2022

Study information

• Verified date: November 2023
• Source: Universiti Tunku Abdul Rahman
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

OneDoc Picopulse™ is a radiopulse technology beauty grade device invented for treating melasma.

Description:

This is a new attempt to evaluate the effectiveness of OneDoc PicopulseTM in treating melasma among women of childbearing age in Klang Valley, Malaysia. This pilot feasibility study protocol is to access feasibility of the OneDoc Picopulse™ in the future definitive trial. The findings of this study would justify OneDoc Picopulse™ as one of the promising alternative treatment for melasma.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 32
• Est. completion date: December 1, 2022
• Est. primary completion date: December 1, 2022
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years to 65 Years

Eligibility

Inclusion Criteria:

• Women presenting dermal melasma with Fritzpatrick skin type III to V
• Malaysian citizen
• Agreed to participate
• Provide informed consent

Exclusion Criteria:

• Patients who had a laser procedure, phototherapy therapy, peel, oral therapy, topical treatment or used lightening creams in the treatment area within the past 6 months.
• Patients with pregnancy, lactating, active dermatitis, had a history of immunosuppression/immune deficiency disorders
• Patients who photosensitivity or taking drugs known to induce photosensitivity,
• Patients that have been exposed to severe sun exposure, having severe epidermal injury, allergy and sensitivity
• Patients who could not attend follow-up treatments

Related Conditions & MeSH terms

• Melanoma (Skin)
• Melanosis
• Skin Diseases
• Skin Disorder

Intervention

Device:
• OneDoc Picopulse
Eligible patients will proceed to receive skin cleansing prior to OneDoc Picopulse treatment. After the cleansing, the patients will receive OneDoc Picopulse treatment for 15 mins. Patients will receive ten picopulse treatments for bi-monthly.

Locations

Country	Name	City	State
Malaysia	OneDoc	Cheras

Sponsors (1)

Lead Sponsor	Collaborator
Universiti Tunku Abdul Rahman

Country where clinical trial is conducted

Malaysia, 

References & Publications (3)

Amini F, Thazin Oo NM, Okechukwu PN, Seghayat MS, Ng ESC. Polymorphisms in P53 and VEGFA genes in different subtypes of periorbital hyperpigmentation in a Malaysian Chinese population. Australas J Dermatol. 2019 May;60(2):e99-e104. doi: 10.1111/ajd.12918. — View Citation

Chalermchai T, Rummaneethorn P. Effects of a fractional picosecond 1,064 nm laser for the treatment of dermal and mixed type melasma. J Cosmet Laser Ther. 2018 Jun;20(3):134-139. doi: 10.1080/14764172.2017.1376098. Epub 2017 Dec 4. — View Citation

Labadie JG, Krunic AL. Long pulsed dye laser with a back-to-back double-pulse technique and compression for the treatment of epidermal pigmented lesions. Lasers Surg Med. 2019 Feb;51(2):136-140. doi: 10.1002/lsm.23009. Epub 2018 Oct 15. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Acceptability of the treatment	Short Assessment of Patient Satisfaction (SAPS) questionnaire with additional Qualitative data collection; The score range for SAPS is from 0 (extremely dissatisfied) to 28 (extremely satisfied)	One month
Secondary	Feasibility of the recruitment and measurement tools	Number of patients referred from OneDoc and eligible for screening; Number of patients recruited; Follow-up response rates (2 weeks and 1 month follow-ups)	Pre-treatment, two weeks and one month
Secondary	Treatment adherence	Number of treatments attended	five months
Secondary	Melasma	Melasma Severity Index (MSI) and by observation; MSI score ranges from 0 (no melasma) to 64 (severe melasma)	Through study completion, an average of 24 weeks
Secondary	Quality of life of patients	Melasma Quality of Life Scale (MELASQOL) score ranges from 10 to 70; Higher the score, worse is the quality of life	Pre-treatment, two weeks and one month post-treatment
Secondary	Safety evaluation	Incidence and severity of side effects caused by treatments	immediately after and before each subsequent treatment