NCT01282515已完成2 期
A Study of Topical Hexaminolevulinate (HAL) Photodynamic Therapy (PDT) and a Phase III Comparative Treatment Study of HAL PDT in Female Genital Erosive Lichen Planus (GELP)
Oslo University Hospital1 个研究点 分布在 1 个国家目标入组 40 人开始时间: 2011年8月最近更新:
适应症
干预措施
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- 入组人数
- 40
- 试验地点
- 1
- 主要终点
- Percentage change of GELP score and/or VAS score 6 weeks after start of treatment.
研究概览
简要总结
To compare the effect and side effects of photodynamic treatment and traditional topical steroid treatment in female genital erosive lichen planus
详细描述
To assess the feasibility, efficacy and safety of hexyl 5-aminolevulinate-hydrocloride (HAL)-PDT in GELP in women.
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 (Investigator)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Women with symptomatically genital ELP, clinically verified by at least one doctor attended to the Vulva clinic.
- •Untreated for ELP for at least 4 weeks. Written Informed Consent signed Age 18 or above
排除标准
- •Current pelvic inflammatory disease, genital malignancy, or gynecological infection.
- •Known or suspected porphyria
- •Known allergy to hexaminolevulinate or similar compounds (e.g. hexaminolevulinate or aminolevulinic acid) Pregnancy and lactation Participation in other clinical study either concurrently or within the last 30 days
研究组 & 干预措施
ELP active
Experimental
one PDT treatment with 2 ml hexaminolevulinate 6 mg/ml gel
干预措施: hexaminolevulinate (Drug)
topical steroids
Active Comparator
treatment with clobetasol propionate 0.05% ointment used daily for 6 weeks
干预措施: clobetasol propionate 0,05% ointment (Drug)
结局指标
主要结局
Percentage change of GELP score and/or VAS score 6 weeks after start of treatment.
时间窗: 6 weeks
次要结局
- Percentage change of GELP score and/or VAS score 6 months after start of treatment.(6 months)
研究者
Anne Lise Helgesen
consultant dermatologist
Oslo University Hospital
研究点 (1)
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