A topical gel of tea tree oil nanoemulsion containing adapalene versus adapalene marketed gel in patients with acne vulgaris: a randomized clinical trial.

Adapalene is used for treatment of acne vulgaris, a common dermatological disease. Nano-based carriers have been developed to improve solubility and bioavailability of adapalene and other acne treatment drugs. In our previous report, tea tree oil nanoemulsion containing adapalene gel (TTO NE + ADA Gel) showed appropriate physical and biological properties such as stability, viscosity, pH, size, morphology and biocompatibility in an animal model. The present study was designed to assess efficacy and safety of the TTO NE + ADA Gel in comparison with 0.1% adapalene marketed gel (ADA Marketed Gel). A total of 100 patients were randomized to receive TTO NE + ADA Gel or ADA Marketed Gel, once daily at night, for 12 weeks. Analysis for efficacy was conducted by acne lesion count (total, inflammatory and non-inflammatory) and acne severity index at weeks 4, 8 and 12 using generalized estimating equation along with the safety assessments in each measurement for assessing dryness, erythema, burning sensation and irritation. Significantly better reduction in total, inflammatory, and non-inflammatory acne lesions were reported for TTO NE + ADA Gel as compared to the ADA Marketed Gel overall and on each measurement occasion (p value < 0.001 for all). Mean acne severity index also reduced with TTO NE + ADA Gel significantly in comparison with ADA Marketed Gel (p value < 0.001). Dryness was the most common adverse effect reported in both groups and it was higher in TTO NE + ADA Gel group. In conclusion, TTO NE + ADA Gel compared to ADA Marketed Gel appears more effective in the treatment of acne vulgaris, with no important change in adverse effects.

Intra tester reliability of sympathetic skin responses in subjects with primary palmar hyperhidrosis.

BACKGROUND: Primary palmar hyperhidrosis (PPH) is a disorder related to sympathetic dysfunction. Iontophoresis can be used to reduce sweating rate. Sympathetic skin response (SSR) is commonly used to evaluate the sympathetic system. However, scarce evidence exists about the reliability of SSR parameters. OBJECTIVE: To assess the relative and absolute reliability of SSR before and after the application of iontophoresis with aluminum chloride hexahydrate (ACH) gel or tap water in subjects with PPH. METHODS: Twenty subjects were randomized to receive either iontophoresis with ACH gel or tap water. Three SSRs (amplitude and latency) with 5 s intervals from both hands in both groups were recorded before and after the application of iontophoresis for 30 min. Reliability of amplitude and latency of the SSR was assessed using intraclass correlation coefficient (ICC) with 95% confidence intervals, standard error of measurement (SEM), and minimal detectable change (MDC). RESULTS: Amplitudes and latencies of SSR showed good to excellent test-retest reliability for ICC in both groups before iontophoresis. Except for right hand latency which was moderate (0.5-0.75). After iontophoresis, the ACH gel group still showed good to excellent agreement for SSR parameters, while the reliability of SSR parameters in the tap water group was reduced. CONCLUSION: Subjects with PPH showed high intra-rater reliability for SSR parameters which was maintained after ACH gel iontophoresis and decreased after tap water iontophoresis. It seems that media used for iontophoresis or the state of media (gel vs liquid) may affect the reliability of SSR. Further research is recommended.

Efficacy of fractional CO2 laser in treatment of atrophic scar of cutaneous leishmaniasis.

Cutaneous leishmaniasis is an endemic disease in Iran. Unfortunately, it can lead to unsightly atrophic scars with limited treatment options. Fractional CO2 laser is accepted for treatment of atrophic acne scars and recently has been used to treat cutaneous leishmaniasis, so we planned to use fractional CO2 laser on leishmaniasis scar. We conducted this study on 60 leishmaniasis scars on the face of 40 patients. The lesions were treated by a fractional CO2 laser with beam size of 120 µm, with energy of 50-90 mJ, and 50-100 spots/cm(2) density with two passes in three monthly sessions. Evaluation was done in the first and second months after the first treatment and 3 and 6 months after the last treatment. Digital photography was performed at each visit. Assessment of improvement rate by patient and physician was rated separately as follows: no improvement (0%), mild (<25%), moderate (25-50%), good (51-75%), and excellent (76-100%). Based on patients' opinion, in the first and second follow-up, 48.3 and 90% of them reported moderate to excellent healing, respectively (p < 0.001). In 3 and 6 months follow-up after the end of the experiment, most of the patients (88.3 and 95%, respectively) reported moderate to excellent healing of scars. Based on two observers' opinion, healing in the first follow-up in most of the patients (65%) was mild to moderate and 33% were reported as having no healing. In the second follow-up, only 5% of the patients were reported with no healing and 60% were reported as having moderate healing (p < 0.001). In 3 and 6 months follow-up, most of the patients (95 and 96.6%) were reported as having moderate to excellent healing (p = <0.001). Our results underlined the high efficacy of fractional CO2 laser for leishmaniasis scar. No significant adverse effects were noted.

Mechanistic analysis of drug release from theophylline pellets coated by films containing pectin, chitosan and Eudragit RS.

The objective of this study was to obtain detailed information on the mechanism of drug release from mixed-film of pectin-chitosan/Eudragit RS. Pellets (710-840 microm in diameter) containing 60% theophylline and 40% microcrystalline cellulose were prepared by extrusion-spheronization method. Eudragit L100-55 enteric coating capsules included film-coated pellets of theophylline in theoretical coating weight gains of 10, 15, and 20%, with pectin-chitosan complex contents of 5, 10, 15, and 20% for each level of weight gain were prepared and subjected to in vitro drug release. Drug release from this system showed a bimodal release profile characteristic with the drug release enhancement, being triggered (burst release) in the colonic medium. The reason for burst drug release may be due to the enzymatic degradation of pectin via pectinolytic enzymes in the simulated colonic medium. The mechanism of drug release from each formulation was evaluated in the terms of zero-order, first-order, Higuchi and Korsmeyer-Peppas models. It was observed that none of the enteric coating capsules showed any drug release in the simulated gastric medium (phase I). The analysis of release profiles showed that zero-order kinetics was found as the better fitting model for all formulations in the simulated small intestine (phase II) and it could be due to the pectin-chitosan swelling and subsequent formation of aqueous channels. In the colonic medium (phase III), due to degradation of pectin and its leaching from the mixed-film, there was a modification in drug release kinetics from swelling-controlled at phase II to anomalous at phase III. It also was found that both zero-order and Higuchi models contributed in colonic drug release from most of the formulations.