0.075% Capsaicin Lotion for the Treatment of Painful Diabetic Neuropathy
0.075% Capsaicin Lotion for the Treatment of Painful Diabetic Neuropathy
To study that 0.075% capsaicin lotion is safe, well tolerated and provide significant pain
 relief in patients with PDN compared with placebo lotion as a randomized, double- Blind,
 crossover, placebo-controlled trial
Neuropathy is one of the most common complications in both type 1 and type 2 diabetes
 mellitus. The most common symptom is a symmetrical, chronic, axonal, length-dependent
 sensorimotor polyneuropathy.

 Topical capsaicin formulations are widely used to manage pain. Low-concentration creams,
 lotions, and patches intended for daily skin application have been available in most
 countries since the early 1980s.

 We study 0.075% capsaicin lotion is safe, well tolerated and provide significant pain relief
 in patients with PDN compared with placebo lotion as a randomized, double- Blind, crossover,
 placebo-controlled trial for 20 weeks throughout the study in 42 participants. All
 participants are provided both 0.075% capsaicin lotion and placebo lotion. Each agent will be
 applied for 8 weeks then stop for 4 weeks, after that another agent will be used for 8 weeks.
 We keep following up all of them by calling and appointment to get information in
 effectiveness and adverse effect at 0,2,4,8,12,14,16,20 week, respectively.
Inclusion Criteria:

 1. DM type 2 over 1 year

 2. Clinical presentation of peripheral sensory such as burning pain

 3. DN4 score from 4 points

 4. Good consciousness to tell their score with informed consent agreement

 5. No adding dosage of previous pain control medications at least 4 weeks

 6. HbA1C 6.5-9.0%

 Exclusion Criteria:

 1. Improper application site of skin for topical drugs such as abrasion wound.

 2. Allergic history of Capsaicin

 3. No intention to join the study with any reasons

 4. Other previous medications used that effect to peripheral neuropathy such as
 Carboplatin, Cisplatin, Colchicine, Dapsone, Etoposide, Ethambutol, Indomethacin,
 Isoniazid, Lithium, Metronidazole, Phenytoin, Pyridoxine, Statins, Stavudine (d4T) or
 conditions worsening peripheral nerves following that poor nutrition, kidney failure,
 chronic alcoholism, vitamin deficiency, Hypothyroidism