Safety and efficacy of oral fusidic acid as a steroid-sparing agent in the treatment of lepra reactions : A randomized controlled assessor-blinded clinical trial

BACKGROUND: Lepra reactions occur in 10-30% of patients with leprosy. The standard of treatment is prednisone. However , prolonged steroid use may cause side effects such as osteoporosis, hypertension, hyperlipidemia, atherosclerosis and infections. Fusidic acid targets cytokine systems responsible for the production of Type 1 lepra reaction (T1R) and erythema nodosum leprosum (ENL). It may be given as a steroid-sparing agent in treating lepra reactions. OBJECTIVE: To determine the safety and efficacy of fusidic acid as a steroid-sparing agent in the treatment of  Type 1 and Type 2  lepra reactions. METHODS: A randomized controlled trial was conducted on 67 subjects with lepra reactions, aged 18-60, each assigned to receive either prednisone or prednisone + fusidic acid for 12 weeks. Severity of lepra reactions were graded quantitatively using a modified scale by Walker et al and van Brakel et al, and qualitatively using modified National Leprosy Control Program (NLCP) Guidelines at baseline, weeks 2,4,6,8,10 and 12. Doses of prednisone needed to control lepra reactions were also noted at each follow up and statistical analyses were done . Adverse reactions were noted. RESULT: Sixty subjects (89.55%) completed the study. The prednisone + fusidic acid group had lower quantitative and qualitative scores compared to the prednisone group. There were significant differences between the two groups for the quantitative severity scores (p=1.44x10-11) and qualitative severity grading (p=9.36x10-14) at week 12. The mean dose of prednisone was 21.5 mg in the prednisone group and 2 mg in the prednisone + fusidic acid group at week 12 (p=1.01x10-12). No adverse reactions were reported. CONCLUSION: Fusidic acid tablet 250mg/tab two tablets three times a day is an effective and safe steroid-sparing agent for the treatment of lepra reactions.

Skin-whitening and skin-condition-improving effects of topical oxidized glutathione: a double-blind and placebo-controlled clinical trial in healthy women.

PURPOSE: Glutathione is a tripeptide consisting of cysteine, glycine, and glutamate and functions as a major antioxidant. It is synthesized endogenously in humans. Glutathione protects thiol protein groups from oxidation and is involved in cellular detoxification for maintenance of the cell environment. Reduced glutathione (GSH) has a skin-whitening effect in humans through its tyrosinase inhibitory activity, but in the case of oxidized glutathione (GSSG) this effect is unclear. We examined the skin-whitening and skin-condition effects of topical GSSG in healthy women. SUBJECTS AND METHODS: The subjects were 30 healthy adult women aged 30 to 50 years. The study design was a randomized, double-blind, matched-pair, placebo-controlled clinical trial. Subjects applied GSSG 2% (weight/weight [w/w]) lotion to one side of the face and a placebo lotion to the other side twice daily for 10 weeks. We objectively measured changes in melanin index values, moisture content of the stratum corneum, smoothness, wrinkle formation, and elasticity of the skin. The principal investigator and each subject also used subjective scores to investigate skin whitening, wrinkle reduction, and smoothness. Analysis of variance was used to evaluate differences between groups. RESULTS: The skin melanin index was significantly lower with GSSG treatment than with placebo from the early weeks after the start of the trial through to the end of the study period (at 10 weeks, P<0.001). In addition, in the latter half of the study period GSSG-treated sites had significant increases in moisture content of the stratum corneum, suppression of wrinkle formation, and improvement in skin smoothness. There were no marked adverse effects from GSSG application. CONCLUSION: Topical GSSG is safe and effectively whitens the skin and improves skin condition in healthy women.

Functional characterisation of a SNP in the ABCC11 allele - effects on axillary skin metabolism, odour generation and associated behaviours.

BACKGROUND: A single nucleotide polymorphism (SNP), 538G→A, leading to a G180R substitution in the ABCC11 gene results in reduced concentrations of apocrine derived axillary odour precursors. OBJECTIVE: Determine the axillary odour levels in the SNP ABCC11 genotype variants and to investigate if other parameters associated with odour production are affected. METHODS: Axillary odour was assessed by subjective quantification and gas chromatography headspace analysis. Metabolite profiles, microbiome diversity and personal hygiene habits were also assessed. RESULTS: Axillary odour in the A/A homozygotes was significantly lower compared to the G/A and G/G genotypes. However, the perception-based measures still detected appreciable levels of axillary odour in the A/A subjects. Metabolomic analysis highlighted significant differences in axillary skin metabolites between A/A subjects compared to those carrying the G allele. These differences resulted in A/A subjects lacking specific volatile odourants in the axillary headspace, but all genotypes produced odoriferous short chain fatty acids. Microbiomic analysis revealed differences in the relative abundance of key bacterial genera associated with odour generation between the different genotypes. Deodorant usage indicated a high level of self awareness of axillary odour levels with A/A individuals less likely to adopt personal hygiene habits designed to eradicate/mask its presence. CONCLUSIONS: The SNP in the ABCC11 gene results in lower levels of axillary odour in the A/A homozygotes compared to those carrying the G allele, but A/A subjects still produce noticeable amounts of axillary odour. Differences in axillary skin metabolites, bacterial genera and personal hygiene behaviours also appear to be influenced by this SNP.

A randomized, double-blind, placebo-controlled trial of oral procyanidin with vitamins A, C, E for melasma among Filipino women.

BACKGROUND: Melasma is a common, acquired, symmetric hypermelanosis characterized by irregular brown to gray-brown macules on the cheeks, forehead, nasal bridge, cutaneous part of the upper lip, mandible, and the upper arms. Few trials have been conducted regarding the potential benefits of oral procyanidin in melasma. AIM: To assess the safety and efficacy of oral procyanidin + vitamins A, C, E among Filipino patients with epidermal melasma. METHODS: A randomized, double-blind, placebo-controlled trial lasting 8 weeks, involving 60 adult female volunteers with bilateral epidermal melasma, Fitzpatrick skin types III-V, was conducted at the Section of Dermatology, Research Institute for Tropical Medicine, Department of Health, Manila, Philippines. Patients received either the test drug or placebo, twice daily with meals. Changes in pigmentation were measured using a mexameter, the melasma area and severity index (MASI), and a global evaluation by the patient and investigator. Safety evaluations were performed at each follow-up visit. RESULTS: Fifty-six patients completed the trial. Mexameter results demonstrated a significant decrease in the degree of pigmentation in the left malar (165.85 +/- 70.909) and right malar (161.33 +/- 61.824) regions (P < 0.0001). MASI scores showed a significant improvement in the left malar (2.4862 +/- 1.67816) and right malar (1.8889 +/- 1.67110) regions (P = 0.001). Procyanidin + vitamins A, C, E proved to be safe and well tolerated, with minimal adverse events. CONCLUSIONS: In this 8-week trial period, oral procyanidin + vitamins A, C, E proved to be safe and effective among Filipino women with epidermal melasma.

Noncompliance with the world health organization-multidrug therapy among leprosy patients in Cebu, Philippines: its causes and implications on the leprosy control program.

The success of current World Health Organization (WHO) key strategy for leprosy elimination (ie, multidrug therapy [MDT] regimen) depends largely on the efficiency of health care delivery services and patient compliance. A high rate of noncompliance with this regimen has serious implications for the leprosy control program because it can set the stage for the emergence of drug resistance, eventually resulting in treatment failure and failure of the program. A community-based descriptive study using pretested interviews conducted in 12 leprosy endemic areas in Cebu, Philippines, showed that the noncompliance rate with the WHO-MDT regimen among 233 study subjects was 30%. The causes of noncompliance are drug-related, health care provider-triggered, or patient-inducted, or some combination of these. Recommendations on strategic interventions to obviate the cause for noncompliance are presented.