A randomized controlled trial of the efficacy and safety of a fixed triple combination (fluocinolone acetonide 0AE01%, hydroquinone 4%, tretinoin 0AE05%) compared with hydroquinone 4% cream in Asian patients with moderate to severe melasma R. Chan, K.C. Park,* M.H. Lee, E-S. Lee
SummaryBackground Melasma is an acquired, chronic hypermelanosis for which therapy remains a challenge. Objectives To compare the efficacy and safety of a triple combination [TC: fluocinolone acetonide 0AE01%, hydroquinone (HQ) 4%, tretinoin 0AE05%] vs. HQ 4% after 8 weeks of treatment of moderate to severe facial melasma in Asian patients. Methods This was a multicentre, randomized, controlled, investigator-blinded, parallel comparison study. East and South-East Asian patients aged 18 years or older, with a clinical diagnosis of moderate to severe melasma, were enrolled in this study. Patients were enrolled at baseline and treated daily for 8 weeks with TC cream (one application at bedtime) or HQ cream (twice daily). There were four study visits: at baseline and weeks 2, 4 and 8. The primary efficacy variable was the melasma global severity score (GSS). Other outcome measures included Melasma Area and Severity Index, global improvement and patient satisfaction. Safety was assessed through the reporting of adverse events. Results TC had superior efficacy to HQ for the primary variable: 77 ⁄120 patients (64AE2%) on TC had GSS 'none' or 'mild' at week 8 vs. 48 ⁄122 patients (39AE4%) on HQ (P < 0AE001). The secondary efficacy variables confirmed these results. Patient satisfaction was in favour of TC (90 ⁄127, 70AE8%, vs. 64 ⁄129, 49AE6%; P = 0AE005). More patients had related adverse events on TC (63 ⁄129, 48AE8%) than on HQ (18 ⁄131, 13AE7%) but most were mild and none was severe. Conclusions Efficacy in Asians and patient satisfaction were superior with the fixed TC than with HQ 4%.
Natural oils include mineral oil with emollient, occlusive, and humectant properties and the plant-derived essential, coconut, and other vegetable oils, composed of triglycerides that microbiota lipases hydrolyze into glycerin, a potent humectant, and fatty acids (FAs) with varying physico-chemical properties. Unsaturated FAs have high linoleic acid used for synthesis of ceramide-I linoleate, a barrier lipid, but more pro-inflammatory omega-6:-3 ratios above 10:1, and their double bonds form less occlusive palisades. VCO FAs have a low linoleic acid content but shorter and saturated FAs that form a more compact palisade, more anti-inflammatory omega-6:-3 ratio of 2:1, close to 7:1 of olive oil, which disrupts the skin barrier, otherwise useful as a penetration enhancer. Updates on the stratum corneum illustrate how this review on the contrasting actions of NOs provide information on which to avoid and which to select for barrier repair and to lower inflammation in contact dermatitis genesis.
BackgroundNovel agents with good safety profiles are needed in the management of chronic kidney disease–associated pruritus (CKD‐AP). This study aims to assess the efficacy and safety of topical gabapentin in the treatment of CKD‐AP.MethodsThe authors conducted a randomized, double‐blind, vehicle‐controlled study. The key inclusion criteria were: (i) patients on hemodialysis for at least 8 weeks, and (ii) a baseline visual analog scale (VAS) pruritus score ≥5. Patients were randomized into two groups. Topical 6% gabapentin was used in the experimental group while plain permeation cream was used for the control group. The primary endpoint was the mean change in pruritus scores using the VAS (MCPS‐VAS) from baseline after 1 and 2 weeks of once daily application.ResultsThirty patients (15 per group) were included in the analysis. Treatment with 6% topical gabapentin resulted in significantly decreased mean pruritus scores at 1 week (mean score 2.7; range 0–5; P < 0.001) and 2 weeks (mean score 1.3, range 0–5; P < 0.001) from baseline (mean score 5.9; range 5–8). The MCPS‐VAS of the two groups were not significantly different (P = 0.8) after 1 week. However, the MCPS‐VAS of the experimental group (mean change −4.6; range 0–7) was significantly greater (P = 0.01) compared to control (mean change −2.6; range −1 to 5) after 2 weeks. There were no drug‐related adverse events reported.ConclusionOur results suggest that short‐term use of topical gabapentin may significantly decrease CKD‐AP severity after 2 weeks with no reported acute adverse events.
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