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

Phase 2

Recruiting

• Conditions: europathic low back pain; Capsaicin.; Low back pain.; Neuralgia.; Nanoparticles.; Topical gel.

• Registration Number: TCTR20230608001
• Lead Sponsor: Bangkok Lab and Cosmetic Public Company Limited

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2023-06-08
• Last Update Posted: 19 August 2024
• Study Completion: 2024-08-31

Recruitment & Eligibility

• Status: Recruiting
• Sex: All
• Target Recruitment: 100

Inclusion Criteria

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.

Exclusion Criteria

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.

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Absolute mean change in pain intensity 8 weeks 11-point pain intensity numerical rating scale (PI-NRS)

Secondary Outcome Measures

Name	Time	Method
Absolute mean change in pain intensity 2 and 4 weeks 11-point pain intensity numerical rating scale (PI-NRS),Pain intensity reduction 2, 4, and 8 weeks 11-point pain intensity numerical rating scale (PI-NRS),Improvement score 2, 4, and 8 weeks Patient global impression of change (PGIC),Improvement score 8 weeks Clinical global impression of change (CGIC),Absolute mean change in the health-related quality of life 2, 4, and 8 weeks EuroQol 5 dimensions, 5 levels questionnaire (EQ-5D-5L),Adverse events Throughout the study Inquiry,Withdrawal Throughout the study Withdrawal