Efficacy and Safety of the Topical Chili Extract-Loaded Lipid Nanoparticle Gel Product Containing 0.075% Capsaicin for the Treatment of Neuropathic Low Back Pain: A Randomized Controlled Trial

Bangkok Lab and Cosmetic Public Company Limited0 个研究点目标入组 100 人开始时间: 2023年6月8日最近更新: 2024年8月19日

适应症

试验速览

暂无简介。

•1. Diagnosed with neuropathic low back pain, no prior back surgery.
•2. Neuropathic pain confirmed by DN4 score of more than 4.
•3. Age: 20-75 years at screening.
•4. Stable pain with consistent oral therapy for more than 2 weeks.
•5. Moderate-to-severe low back pain (PI-NRS score of more than 4 at screening).
•6. Willing to discontinue other topical pain medications for more than 7 days during the study.
•7. Written informed consent provided.

•1. Presence of severe co-morbidity, uncontrolled medical condition(s), or other illness(es) that may preclude participation.
•2. Low back pain caused by conditions other than a neuropathic component.
•3. Significant neurological or psychiatric disorder(s) unrelated to neuropathic pain interfering with pain assessment.
•4. Skin condition(s) where the investigational product will be applied.
•5. Planned elective surgery during the study period, regardless of relevance to the assessed condition.
•6. Contraindications to capsaicin or investigational product ingredients.
•7. Hypersensitivity history to capsaicin or investigational product ingredients.
•8. Pregnancy, breastfeeding, or intent to conceive during the study (applies to both male and female participants).
•9. Alcoholism or substance abuse problem(s).
•10. Recent use of drugs, herbs, or dietary supplements that may interact with capsaicin or investigational product ingredients within 14 days of the screening visit.
•11. Concurrent or recent participation in another clinical trial within 30 days of the screening visit.

发起方

Bangkok Lab and Cosmetic Public Company Limited