Clinical trial NCT03113448: 0.075% Capsaicin Lotion for the Treatment of Painful Diabetic Neuropathy
Official title: 0.075% Capsaicin Lotion for the Treatment of Painful Diabetic Neuropathy: A Randomized, Double- Blind, Crossover, Placebo-Controlled Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Peripheral Diabetic Neuropathy
Keywords: capsaicin
neuropathic pain
diabetic neuropathy
topical lotion
Lead sponsor: Thammasat University
Sponsor class: OTHER
First posted: 2017-04-13
Enrollment: 42
Sex: ALL
Minimum age (years): 20
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Intervention model description: Randomized controlled trial, double blind
Primary purpose: TREATMENT

Brief summary: 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

Detailed description: 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.

Eligibility criteria: 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

Primary outcomes:
measure: Visual analog scale (0-100 mm.)
timeFrame: 20 week
Secondary outcomes:
measure: Short-form McGill Pain Questionnaire(SF-MPQ)
timeFrame: 20 week
measure: Neuropathic Pain Scale (NPS)
timeFrame: 20 week
Other outcomes:
Locations:
city: Pathumthani
country: Thailand
facility: Thammasat University Hospital
Study officials:
affiliation: Thammasat University Hospital
name: Kongkiat Kulkantrakorn, Professor
role: STUDY_CHAIR
affiliation: Phramongkutklao College of Medicine
name: Pasiri Sithinamsuwan
role: STUDY_DIRECTOR
References: