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

Abstract

Background: Women 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. Objectives: This 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. Methods: Outcome 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. Results: Overall, 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. Conclusions: These findings provide promising data that support the acceptability and feasibility for future full-scale clinical studies. This study was registered with ClinicalTrials.gov (NCT04834167).