Acceptability, feasibility and preliminary effectiveness of Picopulse for the treatment of melasma among Malaysian women: A pilot quasi‐experimental

Abstract

AbstractBackgroundWomen are greatly affected by melasma as compared to men and has a significant negative impact on their quality of life. Thus far, there are no well‐conducted trials for melasma in Malaysia.ObjectivesThis multicentre quasi‐experimental pilot study aims to determine the acceptability and feasibility of conducting a preliminary effectiveness trial for the Picopulse treatment effect on melasma severity and quality of life in Malaysian women.MethodsOutcome measures were collected from 32 participants aged 18–65 years old presenting dermal melasma with Fitzpatrick skin type III–V from OneDoc Skin Centres in Klang Valley, Malaysia at baseline, 2 weeks, and 4 weeks after intervention. All preliminary effectiveness analyses were performed under the terms of intention‐to‐treat.ResultsOverall, the average score of Short Assessment of Patient Satisfaction (SAPS) was 22.2 (SD = 4.8), this demonstrated that the treatment was satisfied and well‐accepted by all patients. The recruitment and retention rates were 48.48% and 71.88%, respectively. Twenty‐five out of 32 patients completed all 10 treatments (78.13%). There were significant mean differences in Melasma severity index (MSI) score reported with partial eta square at 0.79 (p < 0.0001), physician global assessment (PGA) with partial eta square at 0.89 (p < 0.0001), and melasma quality of life scale (MELASQoL) with partial eta square at 0.32 (p < 0.05), from baseline measurement to 4 weeks postintervention. The three most common temporary side effects were pain (M = 0.2, SD = 0.46), redness (M = 0.12, SD = 0.24), and dryness (M = 0.11, SD = 0.17), however, all adverse effects were well‐tolerated and resolved without any treatments.ConclusionsThese findings provide promising data that support the acceptability and feasibility for future full‐scale clinical studies. This study was registered with ClinicalTrials.gov (NCT04834167).