A 6-week Randomized, Double-blind, Vehicle-controlled Pilot Study With a 6-week Open Label Extension to Assess the Efficacy and Safety of Pimecrolimus 1% Cream in the Treatment of Oral Lichen Planus
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 21
- 试验地点
- 1
- 主要终点
- The Primary Efficacy Variable Was the Change in the Investigator's Global Assessment of the Overall Severity of Disease From Baseline to Week 6.
研究概览
简要总结
Study investigating the use of pimecrolimus 1% cream for oral lichen planus
详细描述
Lichen planus (LP) is an idiopathic inflammatory dermatosis of the skin and mucous membranes. Cutaneous lesions present as pink polygonal papules on the flexor wrists, trunk, thighs, shin and the dorsal hands. Oral lichen planus (OLP) represents a unique subset of LP and is often the sole manifestation of this disease. Clinically, the lesions can be reticulate, erythematous, atrophic or erosive, with the erosive form being the most common. Lesions can be found anywhere in the oral mucosa and are associated with burning pain which is worsened while eating. The risk of development of squamous cell carcinoma has been estimated to be as high as 5%. Treatments for oral lichen planus involve high potency topical steroid, systemic steroids, oral/topical retinoids and immunosuppressants. However, the long term side effects of steroids (e.g. striae, skin atrophy, telangiectasias, tachyphylaxis, secondary candidiasis and perioral dermatitis) prevent more extensive utilization except in the most severe cases. Given the debilitating nature of OLP, risk of malignant transformation, and long term side effects associated with current therapies, a safe intervention is needed for this disorder.
Tacrolimus and pimecrolimus may have fewer side affects than topical steroids. Recently, in an open label trial of 19 patients with recalcitrant erosive lichen planus, tacrolimus decreased the area of ulceration by 73% after an eight week course. Local irritation was the most common side effect. However, tacrolimus comes in an ointment base, a poorly tolerated vehicle for oral lesions. Topical treatment of oral lesions has also been compromised by problems with maintaining sufficient contact time between poorly adherent cream and ointment preparations and moist mucous membrane surfaces.
This study is designed to evaluate the topical application of pimecrolimus 1% cream when applied twice daily with occlusion in the treatment of oral lichen planus.
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
- Double (Participant, Investigator)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Of any gender, 18 years or older.
- •With a diagnosis of oral lichen planus previously proven on biopsy.
- •With at least one erosion at baseline (baseline IGA of 2 or greater).
- •Signed written informed consent.
- •Willingness and ability to comply with the study requirements.
- •Negative blood pregnancy tests must be documented for all females of childbearing potential prior to enrollment.
排除标准
- •Who have received systemic immunosuppressants (e.g. corticosteroids), or oral retinoids, or any other systemic therapies known or suspected to have an effect on oral lichen planus within 4 weeks prior to participation in the study.
- •Who have been treated with topical therapy (e.g., topical corticosteroids, pimecrolimus, tacrolimus, or topical retinoids, etc) or any other topical therapies known or suspected to have an effect on oral lichen planus within two weeks prior to participation in the study.
- •Who are immunocompromised (e.g., lymphoma, AIDS, Wiskott-Aldrich Syndrome) or have an evidence of malignant disease.
- •Who have systemic or generalized infections (bacterial, viral or fungal).
- •Who have a clinically relevant liver disorder (transaminase enzymes >3 x ULN) or renal disorder (serum creatinine > 10% above upper normal limit).
- •Who have unstable or uncontrolled diabetes or hypertension.
- •Who are currently receiving or are intended to be treated with any potent inhibitor of the enzyme CYP450 3A
- •Treatment with substrates or moderately potent inhibitors of CYP450 3A4 is permitted during the study, under close monitoring for adverse events during that period.
- •Menstruating females of childbearing potential who are not using a medically accepted method of contraception during the study. Medically approved contraception may, at the discretion of the investigator, include abstinence.
- •Women who are breastfeeding.
- •Who had received an investigational drug within four weeks prior to the study or who intended to use other investigational drugs during the course of this study.
- •Who are hypersensitive to pimecrolimus or any of the components of the cream.
- •Patients with severe medical condition(s) that in the view of the investigator prohibits participation in the study.
- •Who have a history of substance abuse or any factor, which limits the subject's ability to cooperate with the study procedures.
- •Who are uncooperative, known to miss appointments (according to subjects' records) and are unlikely to follow medical instructions or are not willing to attend regular visits.
- •History of Netherton's syndrome
- •Patients with lymphadenopathy
研究组 & 干预措施
1
"During the 6-week double-blind phase, all patients will be randomly assigned to receive either pimecrolimus 1% cream or its vehicle twice daily with occlusion on the affected areas. Topical application of pimecrolimus1% cream for oral erosive lichen planus for a duration of 6 weeks; ¼ gram of cream will be applied to each of the 2 sides of the mouth BID with a 2x2 gauze."
干预措施: Pimecrolimus 1% cream (Drug)
2
"During the 6-week double-blind phase, all patients will be randomly assigned to receive either pimecrolimus 1% cream or its vehicle twice daily with occlusion on the affected areas. Topical application of pimecrolimus1% cream for oral erosive lichen planus for a duration of 6 weeks; ¼ gram of cream will be applied to each of the 2 sides of the mouth BID with a 2x2 gauze."
干预措施: Pimecrolimus 1% cream (Drug)
结局指标
主要结局
The Primary Efficacy Variable Was the Change in the Investigator's Global Assessment of the Overall Severity of Disease From Baseline to Week 6.
时间窗: 0, 1, 2, 4, 6 weeks
The primary efficacy variable was the change in the Investigator's Global Assessment of the overall severity of disease from baseline to week 6. Scale is 0-4. 0 is no disease. 4 is worst disease. Minimum score is 0. Maximum score is 4. Measurments were completed day 0, week 1, week 2, week 4, and week 6. Scores are listed at baseline (day 0) and end of study (week 6).
次要结局
- The Secondary Efficacy Variables Was Changes Erythema and Assessment of Spontaneous Pain on a Visual Analog Scale (0-10).(0, 1, 2, 4, 6 weeks)
- The Secondary Efficacy Variable Was Change in the Size of a Target Erosion in Millimeters.(0, 1, 2, 4, 6 weeks)
研究者
Christopher Hull
Associate Professor, Dermatology
University of Utah