Background: Melasma is a challenging dermatological condition during pregnancy. The aim of this study was to determine the clinical efficacy of a topical liposome-encapsulated Aloe vera preparation, on melasma in pregnant women. In order to enhance the bioavailability of Aloe vera leaf gel extract (AGE), liposomes encapsulating Aloe vera were prepared and examined for their biochemical properties.
Methods: In this double-blinded, randomized clinical trial, two groups of pregnant women with melasma who were at their second trimester of pregnancy or later were studied. The patients in the experimental group (90) received liposome-encapsulated AGE (in the form of gel), the other 90 patients were placed in the control group (AGE) for 5 weeks. The liposomes were prepared from a soybean lecithin (SLP-WHITE, 1.0 wt 15 %), with a high trapping efficiency for incorporating about 0.5 wt% AGE concentration. The stable liposomes were then prepared from 1.0 wt% of SLP-WHITE, and different concentrations of AGE were prepared by mechanochemical method using a microfluidizer and homogenizer. The liposomes obtained from 0.25 wt% of AGE were confirmed to be small unilamellar vesicles with a diameter < 200 nm, which remained well dispersed for at least 2 weeks. Our results are expressed as mean (±SD), the Melasma Area Severity Index (MASI) score was used to record melasma severity, and analysis of co-variance (ANCOVA) was used for data analysis.
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Results: After 5 weeks of melasma treatment in pregnant women, there was 32% improvement in the MASI score in the liposomal-AGE treatment group as compared to 10% improvement in the control group. The prevalence of melisma decreases with an increase in parity, i.e. 39 (43.35%), 34 (37.8%), 15 (16.7%) and 2 (2.2%) for the experimental groups, and 45 (50%), 35 (38.9%), 10 (11.1%) and 0 (0%) for the control group (p = 0.32). There was a significant difference between experimental and control groups in terms of mean MASI score after the trial. There was no significant difference between the groups regarding family history of melasma, occupation, frequency of sunscreen usage and hours of sun exposure. However, within each group, there was a slight to great significant difference observed.
Conclusion: Liposome-encapsulated Aloe vera gel extract was superior to AGE in decreasing the severity of melasma in pregnancy due to their ease in percolation; it lightens the melasma, with only mild side effects.
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