ISRCTN77412040已完成不适用
Randomised, observer-blinded, vehicle-controlled trial on the efficacy and safety of a topical indigo naturalis ointment treatment for recalcitrant psoriasis vulgaris
Chang Gung Memorial Hospital (Taiwan)0 个研究点目标入组 40 人开始时间: 2006年3月1日最近更新:
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 40
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
入排标准
- 性别
- All
入选标准
- •1. Participants with bilateral symmetric, chronic plaque-type psoriasis
- •2. Participants who have a history of plaque psoriasis for a minimum of two years
- •3. Participants who have a history of resistance to at least two topical treatments (e.g. corticosteroid and vitamin D3 analogues)
- •4. Participants who have good general health and normal full blood picture, renal, and liver function in tests done before starting the study
- •5. Participants of childbearing age who agree to continue using birth control measures for the duration of the study
- •6. Males and females between 18 and 75 years
排除标准
- •1. Chronic plaque psoriasis involving more than 60% of the body surface
- •2. Pustular or generalised erythrodermic psoriasis
- •3. Use of medications, which affect psoriasis during the study (e.g. systemic therapy including retinoids, methotrexate, cyclosporine, or corticosteroid and non-corticosteroid topical therapy, including vitamin D analogues, tazarotene, tacrolimus)
- •4. Systemic therapy for psoriasis within 30 days of baseline
- •5. Ultra-Violet (UV) light therapy within 21 days of baseline
- •6. Topical therapy within 14 days of baseline
- •7. Participants that test positive for Human Immunodeficiency Virus (HIV), hepatitis B surface antigen, or hepatitis C
- •8. Participants that have a current history of alcohol or drug abuse
- •9. Participants that have a history of hepatitis
- •10. Participants that have a clinically significant laboratory abnormality
- •11. Participants that have a history of sensitivity to Chinese herbs, olive oil, yellow wax and Vaseline
- •12. Female participants who are lactating, pregnant or planning to become pregnant
- •13. Participants that have participated in another clinical trial in the last 30 days
- •14. Participants who are unwilling to comply with study protocol
- •15. Any other conditions, which in the opinion of the investigators could compromise the study
研究者
相似试验
已完成
不适用
A randomized, evaluator-blind, vehicle controlled, parallel group study to explore the effects of the anti-inflammatory drug prednisolone in a TLR4 and TLR7 challenge model in healthy volunteersNL-OMON55304Centre for Human Drug Research60
进行中（未招募）
1 期
Anti-inflammatory drugs in a TRL4 and TLR7 topical challenge modelEUCTR2019-003567-21-NLCentre for Human Drug Research60
进行中（未招募）
1 期
A double-blind, randomized, vehicle-controlled clinical multi-center study to evaluate the efficacy and safety of N-Acetyl-GED-0507-34-LEVO gel, 2 and 5%, applied once daily for 12 weeks in patients with facial acne vulgarisfacial acne vulgarisMedDRA version: 20.0Level: PTClassification code 10000496Term: AcneSystem Organ Class: 10040785 - Skin and subcutaneous tissue disordersEUCTR2018-003307-19-DEPPM SERVICES S.A.450
进行中（未招募）
1 期
A double-blind, randomized, vehicle-controlled clinical multi-center study to evaluate the efficacy and safety of N-Acetyl-GED-0507-34-LEVO gel, 2 and 5%, applied once daily for 12 weeks in patients with facial acne vulgarisfacial acne vulgarisMedDRA version: 20.0Level: PTClassification code 10000496Term: AcneSystem Organ Class: 10040785 - Skin and subcutaneous tissue disordersEUCTR2018-003307-19-ITPPM SERVICES S.A.450
进行中（未招募）
1 期
A double-blind, randomized, vehicle-controlled clinical multi-center study to evaluate the efficacy and safety of N-Acetyl-GED-0507-34-LEVO gel, 2 and 5%, applied once daily for 12 weeks in patients with facial acne vulgarisfacial acne vulgarisMedDRA version: 20.0Level: PTClassification code 10000496Term: AcneSystem Organ Class: 10040785 - Skin and subcutaneous tissue disordersEUCTR2018-003307-19-PLPPM SERVICES S.A.450