ISRCTN81883379已完成未知
A randomised controlled trial of adjunctive systemic therapy for vulval Erosive Lichen Planus
niversity of Nottingham (UK)0 个研究点目标入组 96 人开始时间: 2014年6月12日最近更新:
试验速览
- 阶段
- 未知
- 状态
- 已完成
- 发起方
- 入组人数
- 96
研究概览
简要总结
2016 protocol in: http://www.ncbi.nlm.nih.gov/pubmed/26729245 2018 results in: http://www.ncbi.nlm.nih.gov/pubmed/29975332
研究设计
- 研究类型
- Interventional
入排标准
- 性别
- Female
入选标准
- •Current inclusion criteria as of 08/12/2014:
- •1. Clinical diagnosis of erosive lichen planus affecting the vulvovaginal region (ELPV)
- •2. Documented histological examination in the patient’s history that excludes malignant/pre-malignant disease. Biopsy should be repeated if clinically indicated prior to consideration of systemic therapy
- •3. Inadequate disease control despite first-line therapy with clobetasol propionate 0.05% for at least 3 months
- •4. Moderate or severe disease on Investigator Global Assessment
- •5. Microbiological swabs negative, or result that is not clinically relevant, at study entry
- •6. Willing and capable of giving informed consent
- •7. Willing to have clinical images taken
- •8. Female aged 18 years or over
- •9. Use of effective contraceptive methods in females of childbearing age for the duration of treatment
- •10. For participants receiving methotrexate to use effective contraceptive methods until 6 months after the end of treatment
- •Previous inclusion criteria:
- •1. Clinical diagnosis of erosive lichen planus affecting the vulva
- •2. Histological examination within the past 12 months to exclude alternative diagnoses
- •3. Inadequate control despite first-line therapy with clobetasol propionate 0.05%
- •4. Disease severity of moderate-severe on Investigator Global Assessment
- •5. Negative microbiological swabs at study entry
- •6. Willing and capable of giving informed consent
- •7. Willing to have clinical images taken
- •8. Age >18 years (there is no upper age limit)
- •9. Use of effective contraceptive methods in females of childbearing age
- •Target Gender: Female; Upper Age Limit 99 years ; Lower Age Limit 18 years
排除标准
- •Current exclusion criteria as of 08/12/2014:
- •1. Cases of lichen sclerosus/lichen planus overlap
- •2. Received one or more of the trial drugs within the last one month (excluding clobetasol propionate 0.05%)
- •3. Previous/current diagnosis of malignant disease (skin or internal)
- •4. History of or current diagnosis of pre-malignant vulval skin or cervical disease
- •5. Receiving concurrent medications that would preclude the use of any of the trial medications in normal practice
- •6. History of clinically significant renal or liver impairment or other pre-existing medical conditions that would preclude the use of any of the trial medications in normal practice
- •7. Administration of a live vaccine (BCG, Measles, Mumps, Rubella, Yellow Fever, Oral Polio, Oral Typhoid) within the last 2 weeks
- •8. Pregnancy or breast-feeding
- •9. Known allergy to any of the trial medications
- •Previous exclusion criteria:
- •1. Cases of lichen sclerosus/lichen planus overlap
- •2. Patients taking beta blockers or non-steroidal anti-inflammatory medications
- •3. Received one or more of the trial drugs within the last month (excluding clobetasol propionate 0.05%)
- •4. Previous/current diagnosis of malignant disease (skin or internal)
- •5. Pre-malignant vulval skin or cervical disease
- •6. Receiving concurrent medications that would preclude the use of any of the trial medications in normal practice
- •7. History of clinically significant renal or liver impairment or other pre-existing medical conditions that would preclude the use of any of the trial medications in normal practice
- •8. Administration of a live vaccine (BCG, measles, mumps, rubella, yellow fever, oral polio, oral typhoid) within the last 2 weeks
- •9. Pregnancy or breastfeeding
- •10. Known sensitivity to any of the trial medications
研究者
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