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The treatment of lichen planus (LP) is often controversial and the results, disappointing.1 Most studies are of small series, with only a minority of controlled studies. We compared a new vitamin D3 analog (KH 1060) with the vehicle in the treatment of LP in a prospective, randomized, double-blind, vehicle-controlled, parallel group study. KH 1060 has been shown to inhibit cell proliferation, to induce cell differentiation, and to have a suppressive effect on T-cell activation.2 - 4
The patients recruited had a clinical and histologic diagnosis of LP. Exclusion criteria are given in Table 1. After a washout period of 2 weeks, the patients received twice daily for 8 weeks either KH 1060 (n = 49) or the vehicle (n = 43). The mean age of patients (50.2 years), mean duration of LP (2.0 years), and severity of the disease were similar in the 2 groups. After 2, 4, 6, and 8 weeks of treatment, and 4 weeks after the completion of treatment, the severity of clinical signs was assessed: redness (0-3), itching (0-3), and thickness (0-5). A skin biopsy specimen was taken before randomization and at completion of treatment. The degree of hyperkeratosis, acanthosis, and hypergranulosis was determined, as was the density of infiltrate.
The study was designed to detect a difference of 30% between the treatments at the 5% significance level with a power of 80%. Investigators' overall efficacy assessment and individual clinical symptoms were analyzed using logistic regression. Histologic assessments were analyzed by a Wilcoxon test.
Thirty-eight patients in the KH 1060 group and 36 patients in the vehicle group completed the trial. There was no difference between the treatment groups at the end or after 2 weeks of treatment. In the investigators' overall assessement, the proportions for marked improvement and/or clearance were 37% for KH 1060 compared with 42% for the vehicle (odds ratio, 0.75; 95% confidence interval, 0.31-1.83; P = .53). The odds ratio between the KH 1060 group and the vehicle group was 0.70 for redness (95% confidence interval, 0.32-1.54; P = .38), 1.03 for itching (95% confidence interval, 0.44-2.44; P = .94), and 1.00 for thickness (95% confidence interval, 0.44-2.24; P = .99). There was no difference (P = .24) between the groups regarding the histologic changes from start to end of treatment. There was a marked difference of 45% in the KH 1060 group and 39% in the vehicle group (with least intensive lesions at the end of treatment).
The findings of our study demonstrate that there was no difference between KH 1060 and the vehicle in the treatment of LP. They reinforce the fact that a spontaneous remission of LP may happen; there was approximately 40% clinical improvement and histologic regression with the vehicle. According to the literature, spontaneous remissions of LP after 1 year of evolution occur in 64% to 68% of the cases.5 The course of the disease implies that reports of open cases do not help to suggest active drugs. It is mandatory to perform prospective, randomized, double-blind, vehicle-controlled, parallel group trials to obtain definitive clinical studies for the treatment of LP.
This study was supported by Leo Pharmaceutical Products, Ballerup, Denmark.
The statistical analysis was performed by Simon Day, BSc, of Leo Pharmaceuticals, Buckinghamshire, England.
Country-Specific Mortality and Growth Failure in Infancy and Yound Children and Association With Material Stature
Use interactive graphics and maps to view and sort country-specific infant and early dhildhood mortality and growth failure data and their association with maternal
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