Overview

A 2 Week Study of Topical KD7040 in the Treatment of Postherpetic Neuralgia (PHN)

Status:
Completed
Trial end date:
2008-07-01
Target enrollment:
0
Participant gender:
All
Summary
This study will evaluate the safety and efficacy of 2 weeks of topical KD7040 versus placebo in the treatment of postherpetic neuralgia.
Phase:
Phase 2
Accepts Healthy Volunteers?
No
Details
Lead Sponsor:
Kalypsys, Inc.
Criteria
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.