Effect of Topical Insulin on Healing Rate of Pemphigus Lesions
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 20
- 试验地点
- 1
- 主要终点
- Time to Complete Healing
研究概览
简要总结
This study investigates the efficacy of topical insulin in promoting healing of pemphigus vulgaris erosions. Twenty patients with pemphigus vulgaris were enrolled, each contributing three comparable lesions randomly allocated to receive long-acting insulin (insulin glargine), short-acting insulin (regular insulin), or normal saline control. Treatments were applied topically twice daily for 14 days or until complete healing.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Single (Participant)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Confirmed diagnosis of pemphigus vulgaris by clinical and histopathological criteria
- •Presence of erosions and/or ulcers on skin and/or mucous membranes
- •At least three lesions of comparable location, size, depth, and healing stage
排除标准
- •Lesions with clinical signs of secondary infection (purulence, surrounding erythema, fever)
- •Uncontrolled general condition significantly affecting wound healing (e.g., hypoalbuminemia)
- •Known allergy to insulin
研究组 & 干预措施
Long-acting insulin (LA)
Lesions treated with topical insulin glargine (Lantus) 0.1 mL per 10 cm² twice daily
干预措施: insulin glargine (Drug)
Regular human insulin (SA)
Lesions treated with topical regular insulin (Actrapid) 0.1 mL per 10 cm² twice daily
干预措施: human insulin (Drug)
control
Lesions treated with topical 0.9% normal saline 0.1 mL per 10 cm² twice daily
干预措施: 0.9% Normal Saline (Drug)
结局指标
主要结局
Time to Complete Healing
时间窗: Up to 14 days
Number of days required for complete epithelialization of the lesion
次要结局
- Lesion Surface Area Reduction(Baseline, Day 7, Day 14)
- Daily Healing Rate(14 days)