ACTHAR Gel for Cutaneous Sarcoidosis: An Open Label Trial
试验速览
- 阶段
- 2 期
- 入组人数
- 10
- 试验地点
- 1
- 主要终点
- The change in SASI induration & erythema score.
研究概览
简要总结
ACTHAR gel has efficacy in the treatment of cutaneous sarcoidosis
详细描述
Sarcoidosis is a multisystem granulomatous disease of unknown cause. Although sarcoidosis most commonly affects the lung3, it may affect any organ. Although corticosteroids are recognized as the drug of choice for sarcoidosis, ACTH is the only drug that is FDA-approved for this disorder. However, there is limited data on the efficacy of ACTH for this condition.
Presently, corticosteroids as considered the drug of choice for the treatment of cutaneous sarcoidosis. However, ACTHER GEL not only has obvious anti-inflammatory effects by resulting in corticosteroid production, but it may also activate melanocortin receptors. The melanocortin system has powerful anti-inflammatory properties that may be beneficial in the treatment of cutaneous sarcoidosis.
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
- None
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
- •Patients must have biopsy-proven sarcoidosis.
- •a) Patients with active cutaneous sarcoidosis and two active lesions on stable therapy or no therapy for at least two months AND/OR b) Patients with active cutaneous sarcoidosis and lupus pernio lesions on stable therapy or no therapy for at least two months. A maximum of 5 patients may be enrolled fulfilling criterion b) above.
- •Both lesions must have a SASI induration score of > 1 and a SASI induration + erythema score of >
- •If two lesions are present, one must be > 1cm in diameter and the subject must be willing to have it biopsied. The second lesion must be at least 0.5 cm in diameter.
- •If a subject has only lupus pernio facial lesions, one needs to be at least 0.5 cm in diameter.
排除标准
- •Previous toxic or allergic reaction to ACTHAR gel
- •The presence of another skin condition in addition to sarcoidosis that would interfere with the assessment of the sarcoidosis skin lesions.
- •Uncontrolled hypertension.
- •Uncontrolled diabetes.
- •Active infection.
- •A medical condition that, in the opinion of the investigator would place the subject at significant risk by administering ACTHAR gel.
研究组 & 干预措施
ACTHAR Gel 40 units twice weekly
ACTHAR Gel at a dose of 40 units twice weekly sub cutaneous injections between Baseline and week 12.
干预措施: ACTHAR Gel 40 units twice weekly (Drug)
ACTHAR Gel 80 units twice weekly
ACTHAR gel at a dose of 80 units twice weekly sub cutaneous injections between Baseline and week 12.
干预措施: ACTHAR Gel 80 units twice weekly. (Drug)
结局指标
主要结局
The change in SASI induration & erythema score.
时间窗: Between week 0 and week 12.
次要结局
- Photographic change(Between week 0 and week 12.)
- SAT skin module(Between week 0 and week 12.)
- DLQI(Between week 0 and week 12.)
- Extent of granulomatous inflammation in the biopsy lesion(Between week 0 and week 12.)
研究者
Marc A. Judson, MD
Marc A. Judson, MD
Albany Medical College