OneDoc Picopulse™ for the Treatment of Melasma Among Malaysian Women

Tunku Abdul Rahman University (UTAR)

Status: Completed

Conditions: Skin Disorder; Melanoma (Skin); Skin Diseases

Treatments: Device: OneDoc Picopulse

Study type: Interventional

Funder types: Other

Identifiers

NCT04834167

UTAR-45-2021

Details and patient eligibility

About

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

Full 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.

Enrollment: 32 patients

Sex: Female

Ages: 18 to 65 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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32 participants in 1 patient group

Treatment

Experimental group

Description:

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

Treatment:

Device: OneDoc Picopulse