This study evaluated the efficacy and safety of a 0.75% topical capsaicin nanoparticle preparation compared to a placebo for pain relief in patients with painful diabetic neuropathy. The randomized, double-blind study assigned 60 patients to apply the capsaicin nanoparticle cream or identical placebo cream twice daily for 12 weeks to areas of neuropathic pain. The primary outcome was reduction in pain scores measured on a visual analog scale. The goal was to determine if the nanoparticle formulation provided pain relief while minimizing burning sensations compared to conventional high-dose capsaicin preparations.

1. STUDY OF TOPICAL PREPARATION OF CAPSAICIN
NANOPARTICLE IN PATIENT WITH PAINFUL
DIABETIC NEUROPATHY
(NCT01125215)
Presented by:
Emmanuel E. Egom, MSc, MD, PhD, MRCP (UK)
At the Academy of Applied Pharmaceutical Sciences
(AAPS) in Toronto
12/18/2014

2. OVERVIEW
 Background
 Methods of generating nanoparticles
 Objective and primary outcome of the study
 Study design
 Recruitment Information
 Inclusion and exclusion criteria
 Arms and assigned Intervention

3. BACKGROUND
 Painful diabetic neuropathy is the most common cause of
neuropathic pain.
 0.075% topical capsaicin has been used to treat the pain.
 Because of high concentration, conventional capsaicin
topical preparation may cause burning sensation.

4.  The nanoparticle of capsaicin topical preparation was
developed with expectation of remaining efficacy,
minimizing burning sensation and improving convenience
of use.
 The nanoparticle of capsaicin may be prepared by nano-
precipitation method.

5. METHODS OF GENERATING NANOPARTICLES
Schematic representation of gelatin nanoparticle formation by nanoprecipitation technique. Macromolecular
Bioscience.. Volume 13, Issue 4, pages 455-463, 20 FEB 2013 DOI: 10.1002/mabi.201200382.

6. OTHER METHODS
 http://bio-solutions.blogspot.ca/2009/05/laser-
generation-of-nanoparticles-in.html
 https://www.youtube.com/watch?v=Al5mG7bVAzE
 https://www.youtube.com/watch?v=6zurHSq4CB4

7. OBJECTIVE AND PRIMARY OUTCOME OF THE
STUDY
 To determine efficacy and safety of 0.75% topical
capsaicin nanoparticle preparation versus placebo
in patient with painful diabetic neuropathy.
 Primary Outcome Measures: Pain relief from pain
score reduction, using visual analog scale (VAS) [

8. STUDY DESIGN
 Allocation: Randomized
 Endpoint Classification: Safety/Efficacy Study
 Intervention Model: Parallel Assignment
 Masking: Double Blind
(Subject, Caregiver, Investigator, Outcomes
Assessors)
 Primary Purpose: Treatment

9. RECRUITMENT INFORMATION
 Recruitment Status: Active, not recruiting
 Estimated Enrollment: 60
 Start Date: September 2009
 Estimated Completion Date: December 2013
 Location Countries: Thailand
 Eligibility:
Ages Eligible for Study: 18 Years and older Genders
Eligible for Study: Both
Accepts Healthy Volunteers: No

10. INCLUSION CRITERIA
 History of type 2 Diabetes mellitus
 Peripheral neuropathy
 Stabilized on pain medication for at least one month
 No previous invasive intervention for pain relief

11. EXCLUSION CRITERIA
 Local wound or any skin abnormality in the
applicable area
 Allergic to capsaicin
 Refuse to participate or give consent
 Has other significant disease or receive medication
that may worsen neuropathy

12. ARMS AND ASSIGNED INTERVENTION
 (1) Experimental group: 0.75% capsaicin
nanoparticle cream apply to area with neuropathic
pain twice daily for 12 weeks
 (2) Placebo Comparator group: Identical cream
base of nanoparticle apply to area with neuropathic
pain twice daily for 12 weeks

13. Thank you
Any questions?