Clinical trial NCT04834167: OneDoc Picopulse™ for the Treatment of Melasma Among Malaysian Women
Official title: OneDoc Picopulse™ for the Treatment of Melasma Among Malaysian Women
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Skin Diseases
Skin Disorder
Melanoma (Skin)
Keywords: Melasma
Skin treatment
Picopulse
Malaysian women
Lead sponsor: Universiti Tunku Abdul Rahman
Sponsor class: OTHER
First posted: 2021-04-08
Enrollment: 32
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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

Detailed 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.

Eligibility criteria: 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

Primary outcomes:
measure: Acceptability of the treatment
timeFrame: One month
Secondary outcomes:
measure: Feasibility of the recruitment and measurement tools
timeFrame: Pre-treatment, two weeks and one month
measure: Treatment adherence
timeFrame: five months
measure: Melasma
timeFrame: Through study completion, an average of 24 weeks
measure: Quality of life of patients
timeFrame: Pre-treatment, two weeks and one month post-treatment
measure: Safety evaluation
timeFrame: immediately after and before each subsequent treatment
Other outcomes:
Locations:
city: Cheras
country: Malaysia
facility: OneDoc
Study officials:
affiliation: Universiti Tunku Abdul Rahman
name: Yang Mooi Lim, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
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.
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.