Skip to main content
OpenTrials
Completed

NCT Number: NCT04834167

OneDoc Picopulse™ for the Treatment of Melasma Among Malaysian Women

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

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Skin Diseases Hyperpigmentation Melanoma Melanoma (Skin) Melanosis Neoplasms Neoplasms by Histologic Type Neoplasms by Site Neoplasms, Germ Cell and Embryonal Neoplasms, Nerve Tissue Neuroectodermal Tumors Neuroendocrine Tumors Nevi and Melanomas Pigmentation Disorders Skin Disorder Skin Neoplasms Skin and Connective Tissue Diseases

Age range

18 year–65 year

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

OneDoc

Cheras, Malaysia

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

OneDoc Picopulse

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.

Primary outcomes

  1. Acceptability of the treatment

    Time frame: One month

    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)

Secondary outcomes

  1. Feasibility of the recruitment and measurement tools

    Time frame: Pre-treatment, two weeks and one month

    • 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)

  2. Treatment adherence

    Time frame: five months

    Number of treatments attended

  3. Melasma

    Time frame: Through study completion, an average of 24 weeks

    Melasma Severity Index (MSI) and by observation; MSI score ranges from 0 (no melasma) to 64 (severe melasma)

  4. Quality of life of patients

    Time frame: Pre-treatment, two weeks and one month post-treatment

    Melasma Quality of Life Scale (MELASQOL) score ranges from 10 to 70; Higher the score, worse is the quality of life

  5. Safety evaluation

    Time frame: immediately after and before each subsequent treatment

    Incidence and severity of side effects caused by treatments

Sponsors and collaborators

Lead sponsor

Universiti Tunku Abdul Rahman

Other

Registry information

Important dates

Study start
2021
Primary completion
2022
Study completion
2022
First posted
Apr 8, 2021
Registry last updated
Nov 30, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.