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OneDoc Picopulse™ for the Treatment of Melasma Among Malaysian Women

NCT ID: NCT04834167

Last Updated: 2023-11-30

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

32 participants

Study Classification

INTERVENTIONAL

Study Start Date

2021-05-01

Study Completion Date

2022-12-01

Brief Summary

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

Detailed Description

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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.

Conditions

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Skin Diseases Skin Disorder Melanoma (Skin)

Keywords

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Melasma Skin treatment Picopulse Malaysian women

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Treatment

Eligible patients will receive ten picopulse treatments for bi-monthly.

Group Type EXPERIMENTAL

OneDoc Picopulse

Intervention Type DEVICE

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.

Interventions

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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.

Intervention Type DEVICE

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

65 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No

Sponsors

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Universiti Tunku Abdul Rahman

OTHER

Sponsor Role lead

Responsible Party

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Yang Mooi Lim

Deputy Director (Institute of Postgraduate Studies and Research), Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Yang Mooi Lim, PhD

Role: PRINCIPAL_INVESTIGATOR

Universiti Tunku Abdul Rahman

Locations

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OneDoc

Cheras, , Malaysia

Site Status

Countries

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Malaysia

References

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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. Epub 2018 Sep 14.

Reference Type RESULT
PMID: 30215845 (View on PubMed)

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.

Reference Type RESULT
PMID: 29020467 (View on PubMed)

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.

Reference Type RESULT
PMID: 30320904 (View on PubMed)

Other Identifiers

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UTAR-45-2021

Identifier Type: -

Identifier Source: org_study_id