Abstract：
BACKGROUND: Primary cutaneous macular amyloidosis (PCMA) is a chronic pruritic cutaneous disease characterized by heterogeneous extracellular deposition of amyloid protein in the skin.
OBJECTIVE: This study aimed to evaluate the efficacy of topical 6% gabapentin cream for the treatment of patients with PCMA.
METHODS: In this triple-blind clinical trial, a total of 34 patients, who were diagnosed with PCMA, treated using two different strategies of topical gabapentin as the active group and vehicle cream as the control group.
RESULTS: Pruritus score reduction in both groups was statistically significant compared with the baseline value (p < 0.001). There was a significant pigmentation score reduction in intervention group compared with control group after 1 month of the study (p < 0.001). The differences of pigmentation score changes between the groups were not significant at month 2 (p = 0.52) and month 3 (p = 0.22).
CONCLUSIONS: The results of this study suggest that topical gabapentin cream may be effective as a topical agent in the treatment of pruritus associated with PCMA without any significant adverse effects. It is recommended to perform similar studies with a larger sample size and longer duration in both sexes.
OBJECTIVE: This study aimed to evaluate the efficacy of topical 6% gabapentin cream for the treatment of patients with PCMA.
METHODS: In this triple-blind clinical trial, a total of 34 patients, who were diagnosed with PCMA, treated using two different strategies of topical gabapentin as the active group and vehicle cream as the control group.
RESULTS: Pruritus score reduction in both groups was statistically significant compared with the baseline value (p < 0.001). There was a significant pigmentation score reduction in intervention group compared with control group after 1 month of the study (p < 0.001). The differences of pigmentation score changes between the groups were not significant at month 2 (p = 0.52) and month 3 (p = 0.22).
CONCLUSIONS: The results of this study suggest that topical gabapentin cream may be effective as a topical agent in the treatment of pruritus associated with PCMA without any significant adverse effects. It is recommended to perform similar studies with a larger sample size and longer duration in both sexes.
摘要：
背景：原发性皮肤黄斑淀粉样变性（PCMA）是一种慢性瘙痒性皮肤病，其特征是皮肤中淀粉样蛋白的异质细胞外沉积。
目的：本研究旨在评估外用6%加巴喷丁乳膏治疗PCMA患者的疗效。
方法：在这项三盲临床试验中，共有34名患者，被诊断出患有PCMA，使用两种不同的策略，局部加巴喷丁作为活性组和载体乳膏作为对照组。
结果：与基线值相比，两组的瘙痒评分降低均具有统计学意义（p<0.001）。研究1个月后，干预组的色素沉着评分明显低于对照组（p<0.001）。在第2个月（p=0.52）和第3个月（p=0.22），两组之间的色素沉着评分变化差异不显著。
结论：这项研究的结果表明，外用加巴喷丁乳膏作为外用药物治疗PCMA相关瘙痒可能是有效的，没有任何明显的不良反应。建议在两种性别中进行更大的样本量和更长的持续时间的类似研究。
目的：本研究旨在评估外用6%加巴喷丁乳膏治疗PCMA患者的疗效。
方法：在这项三盲临床试验中，共有34名患者，被诊断出患有PCMA，使用两种不同的策略，局部加巴喷丁作为活性组和载体乳膏作为对照组。
结果：与基线值相比，两组的瘙痒评分降低均具有统计学意义（p<0.001）。研究1个月后，干预组的色素沉着评分明显低于对照组（p<0.001）。在第2个月（p=0.52）和第3个月（p=0.22），两组之间的色素沉着评分变化差异不显著。
结论：这项研究的结果表明，外用加巴喷丁乳膏作为外用药物治疗PCMA相关瘙痒可能是有效的，没有任何明显的不良反应。建议在两种性别中进行更大的样本量和更长的持续时间的类似研究。
