0.075% Capsaicin Lotion for the Treatment of Painful Diabetic Neuropathy: A Randomized, Double- Blind, Crossover, Placebo-Controlled Trial

• Register: TCTR
• Last refreshed on: 29 April 2024
• Main ID: TCTR20170407001
• Date of registration: 07/04/2017
• Prospective Registration: No
• Primary sponsor: BANGKOK DRUG CO.,LTD
• Public title: 0.075% Capsaicin Lotion for the Treatment of Painful Diabetic Neuropathy: A Randomized, Double- Blind, Crossover, Placebo-Controlled Trial
• Scientific title: Topical therapy may provide additional benefit in patients with painful diabetic neuropathy (PDN).This study was conducted to study the safety and efficacy of0.075% capsaicin lotion in this condition
• Date of first enrolment: 19/01/2017
• Target sample size: 42
• Recruitment status: Recruiting
• URL: https://www.thaiclinicaltrials.org/show/TCTR20170407001
• Study type: Interventional
• Study design: Randomized
• Phase: Phase 3

Countries of recruitment

Thailand

Contacts

• Name: Assawin Chomjit
• Affiliation: Unaffiliated

• Name: Assawin Chomjit
• Affiliation: Unaffiliated

Key inclusion & exclusion 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 nutritiion, kidney failure, chronic alcholism, vitamin deficiency, Hypothyroidism

Age minimum: 20 Years
Age maximum: 0 N/A (No limit)
Gender: Both

Health Condition(s) or Problem(s) studied

Gastrointestinal disorders, Application site disorders, Infections, Nervous system disorders, Vascular disorders
capsaicin, neuropathic pain, diabetic neurop-athy, topical lotion

capsaicin, neuropathic pain, diabetic neurop-athy, topical lotion

Intervention(s)

0.075% Capsaicin Lotion,Placebo

Active Comparator Drug,Placebo Comparator Drug

0.075% Capsaicin Lotion is used for application at skin area involved with symptomatic neuropathic pain (both feet or/and hands), 3-4 times a day, everyday for 8 weeks then stop,Placebo Lotion is used for application at skin area involved with symptomatic neuropathic pain (both feet or/and hands), 3-4 times a day, everyday for 8 weeks then stop

Primary Outcome(s)

Visual analog scale (0-100 mm.) at 20 weeks after end of the intervention scale

Secondary Outcome(s)

Short-form McGill Pain Questionnaire(SF-MPQ) at 20 weeks after end of the intervention scale,Neuropathic Pain Scale (NPS) at 20 weeks after end of the intervention scale

Source(s) of Monetary Support

BANGKOK DRUG CO.,LTD

Secondary Sponsor(s)

Thammasat University

Ethics review

Status: Submitted, approved
Approval date:
Contact:

The Human Ethics Committee of Thammasat University

[phone] Ext.

Results

• Date Completed: 21/04/2017