Martha Ann McCarty

Complex aphthosis and Behçet's disease

Complex aphthosis is a disorder in which patients develop recurrent oral and genital aphthous ulcers or almost constant, multiple oral aphthae, without manifestations of systemic disease. Behçets disease is a multisystem disease characterized clinically by oral and genital aphthae, arthritis, cutaneous lesions, and ocular, gastrointestinal, and neurologic manifestations. This article reviews both disorders, including their clinical and histologic presentations, factors in pathogenesis, and includes an overview of therapeutic modalities.

An open‐label pilot study to evaluate the safety and efficacy of topically applied tacrolimus ointment for the treatment of hand and/or foot eczema

BACKGROUND: Hand and foot eczema is a chronic skin disorder. Although topical corticosteroids are often used to control the predominant symptoms of the disease, the chronicity of the condition increases the risk of long‐term adverse effects. A safer alternative is needed. OBJECTIVE: To evaluate the safety and efficacy of tacrolimus ointment 0.1% in hand and/or foot eczema. METHODS: Twenty‐five adults applied tacrolimus ointment 0.1% to affected areas three times daily for 8 weeks and were followed for 2 additional weeks. RESULTS: Except for vesiculation, compared with baseline there were significant improvements in erythema, scaling, induration, fissuring, composite severity, and pruritus (p<0.007). Two weeks after discontinuing treatment, significant improvement in scaling and composite severity (p<0.03) persisted, whereas erythema, induration, vesiculation, fissuring, and pruritus had returned to pre‐treatment levels. CONCLUSION: Tacrolimus ointment 0.1% is a promising corticosteroid alternative for hand/foot eczema.

A topical azithromycin preparation for the treatment of acne vulgaris and rosacea

BACKGROUND: Erythromycin is a common therapy for acne and rosacea. A newer macrolide, azithromycin, offers superior tissue distribution and cellular concentration and is an effective oral anti‐acne agent. Topical formulations such as erythromycin have been a major clinical therapy for acne. To date, no topical solution of azithromycin is available for the treatment of acne. OBJECTIVE: To prepare a stable topical 2% azithromycin formulation that could be used in an acne clinical trial to determine the efficacy of topical azithromycin in treating subjects with acne vulgaris and acne rosacea. METHODS: The study was divided into two phases. In phase I, azithromycin was prepared over a range of ethanol/water concentrations to determine solubility. The stability of a 2% azithromycin in 60% ethanol/water preparation was assessed by high‐pressure liquid chromatography. The temperature, light, and pH dependence of the stability was also assessed. In phase II, a single center, randomized, double‐blind, treatment‐controlled study compared once‐nightly application of topical 2% azithromycin versus 2% erythromycin. A total of 20 subjects with moderate inflammatory acne and 20 with rosacea were examined clinically at 0, 2, 4, 8, and 12 weeks for a 12‐week period. Efficacy was evaluated with the Physicians Visual Analog Scale evaluation (PVAS), the papulopustule count, and acne severity rating (in subjects with acne). RESULTS: In phase I, azithromycin was soluble in 60% ethanol/water. A 2% azithromycin in 60% ethanol/water solution maintained stability at room temperature for up to 26 weeks but at 37°C there was some decay (16%) at 26 weeks. The stability was greatest at pH 6.8 and was unaffected by ambient light exposure. In phase II, the number of inflammatory lesions decreased in both acne and rosacea subjects treated with 2% erythromycin (7.56, p=0.03 and 4.4, p=0.01, respectively). Azithromycin was not as effective for the treatment of rosacea. Both azithromycin (p=0.01) and erythromycin (p=0.03) treatment significantly reduced the inflammatory lesion count in acne vulgaris. No significant adverse events were identified in the acne group. In patients with rosacea, transient irritation occurred in five patients. CONCLUSIONS: A 2% azithromycin in 60% ethanol/water solution can be prepared and is stable for at least 6 months at room temperature. The methodology and power of the study were adequate to identify improvement in acne vulgaris and rosacea. Though it appears the formulation of topical azithromycin was at least comparable with topical erythromycin, larger studies would be needed to determine whether topical azithromycin has any significant advantage over topical erythromycin.

A Randomized, Double-Blind, Vehicle-Controlled, Right/Left Comparative Study of the Efficacy of Acitretin with and without the Co-Administration of 0.1% Tacrolimus Topical Ointment in the Treatment of Moderate to Severe Psoriasis

Background Topical tacrolimus is effective as monotherapy for inverse psoriasis. Its use in combination with other systemic agents may be an effective treatment for psoriasis in less sensitive areas. Objective To determine if topical tacrolimus in combination with oral acitretin is more effective than oral acitretin and vehicle ointment. Methods All patients received oral acitretin; subjects were randomized to apply topical tacrolimus to one side of their body and vehicle to the other. Results Topical tacrolimus was more effective than vehicle ointment as early as week 4. There were no serious adverse events thought to be due to drug or dose changes during the study. Limitations Due to the short time horizon of the study, it may not be appropriate to generalize the results to longer treatment periods. Conclusions Topical tacrolimus is an effective psoriasis treatment and was well-tolerated when combined with systemic acitretin in the treatment of psoriasis.