To investigate the safety and efficacy of oral methylprednisolone combined with azathioprine sodium or mycophenolate mofetil for the treatment of bullous pemphigoid.Design: A prospective, multicenter, randomized, nonblinded clinical trial to compare 2 parallel groups of patients with bullous pemphigoid undergoing different treatments.Setting: Thirteen departments of dermatology in Germany.Patients: Patients with bullous pemphigoid (n=73) as evidenced by clinical lesions suggestive of bullous pemphigoid, signs of subepidermal blistering on histologic analysis of skin biopsy specimens, linear deposition of IgG and C3 along the dermoepidermal junction, and deposition of autoantibodies at the blister roof in split-skin analysis.Interventions: Treatment with oral methylprednisolone plus azathioprine (azathioprine group) or oral methylprednisolone plus mycophenolate mofetil (mycophenolate mofetil group).
Main Outcome Measures:The cumulative total methylprednisolone doses and rates of remission. Secondary outcome measures were safety profiles and duration of remission.
Background: Lichen sclerosus of the anogenital area is a chronic inflammatory and fibrosclerotic disease associated with substantial morbidity. Topical ultrapotent corticosteroids are currently the treatment of choice. Observations: Three prepubertal girls and 3 adults (2 men, 1 woman) were treated with 0.1% tacrolimus ointment once daily. All patients experienced complete resolution with long-lasting remission for up to 1 year. No major adverse effects were observed, and treatment was well tolerated. Conclusions: Topical tacrolimus is a promising novel agent in the treatment of lichen sclerosus of the anogenital area. A major advantage over topical corticosteroids is the lack of skin atrophy. Further clinical trials are warranted to confirm our findings.
Although basic research provides plausible mechanisms for benefits of beta carotene supplementation on nonmelanoma skin cancer (NMSC) primarily consisting of basal cell carcinoma (BCC) and squamous cell carcinoma (SCC), observational studies are inconsistent. Randomized trial data are limited to 1 trial of secondary prevention that showed no effect of beta carotene on the incidence of NMSC after 5 years.Objective: To test whether supplementation with beta carotene reduces the risk for development of a first NMSC, including BCC and SCC.Design: Randomized, double-blind, placebo-controlled trial with 12 years of beta carotene supplementation and follow-up.Setting: Physicians' Health Study in the United States.Participants: Apparently healthy male physicians aged 40 to 84 years in 1982 (N = 22 071).Intervention: Beta carotene, 50 mg, on alternate days.Main Outcome Measure: Relative risk (RR) and 95% confidence interval (CI) for a first NMSC, BCC, and SCC.Results: After adjusting for age and randomized aspirin assignment, there was no effect of beta carotene on the incidence of a first NMSC (RR, 0.98; 95% CI, 0.92-1.05), BCC (RR, 0.99; 95% CI, 0.92-1.06), or SCC (RR, 0.97; 95% CI, 0.84-1.13). There was also no significant evidence of beneficial or harmful effects of beta carotene on NMSC by smoking status (current, past, or never).
Conclusion:This large-scale, randomized, primary prevention trial among apparently healthy well-nourished men indicates that an average of 12 years of supplementation with beta carotene does not affect the development of a first NMSC, including BCC and SCC.
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