Systemic therapy for vulval erosive lichen planus
- Conditions
- Topic: DermatologySubtopic: Skin (all Subtopics)Disease: DermatologySkin and Connective Tissue Diseases
- Registration Number
- ISRCTN81883379
- Lead Sponsor
- niversity of Nottingham (UK)
- Brief Summary
2016 protocol in: http://www.ncbi.nlm.nih.gov/pubmed/26729245 2018 results in: http://www.ncbi.nlm.nih.gov/pubmed/29975332
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- Female
- Target Recruitment
- 96
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
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
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method