Herpes Zoster, Neuropathic Pain, Postherpetic Neuralgia, Shingles
Conditions
Brief summary
This study will evaluate the safety and efficacy of 2 weeks of topical KD7040 versus placebo in the treatment of postherpetic neuralgia.
Interventions
DRUGKD7040 Topical Gel
KD7040 topical gel
DRUGPlacebo gel
Placebo gel
Sponsors
Kalypsys, Inc.
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to 85 Years
Healthy volunteers
No
Inclusion criteria
* Male or female subjects ages 18-85 years * Previous diagnosis of Shingles (Herpes Zoster) with pain persisting for at least 3 months, but not longer than 5 years, after healing of rash * Subject with intact skin in the targeted treatment area * Female subjects of childbearing potential must have a negative serum pregnancy test at screening, a negative urine human chorionic gonadotropin (hCG) test prior to randomization, and must use medically acceptable methods of birth control. All subjects must agree to take every precaution to ensure that pregnancy will not occur during the study. * Subject must be willing and able to complete screening and study procedures as described int he protocol. * Subject must voluntarily provide written Informed Consent prior to participation.
Exclusion criteria
* Subjects with known hypersensitivity to KD7040 or methylparaben, or previous exposure to KD7040. * Subjects pregnant, nursing or planning to become pregnant. * Subjects who are immunocompromised or have clinically significant hematological abnormalities. * Subjects with system dermatological conditions (e.g., psoriasis, atopic dermatitis) or impaired wound healing. * Subjects who have had local anesthetic nerve blocks within 48 hours of study entry. * Subjects having other sever pain which may confound assessment of PHN. * Subjects who have serious, unstable, or clinically significant medical or psychological conditions, which, in the opinion of the Investigator(s) would compromise the subjects' participation in the study.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Worst daily pain | Once daily |
Secondary
| Measure | Time frame |
|---|---|
| Average daily pain | Once daily |
Countries
United States
Outcome results
None listed