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

Kalypsys

Status and phase: Completed; Phase 2

Conditions: Postherpetic Neuralgia; Shingles; Neuropathic Pain; Herpes Zoster

Treatments: Drug: KD7040 Topical Gel; Drug: Placebo gel

Study type: Interventional

Funder types: Industry

Identifiers

NCT00576108

KD7040-NP02

Details and patient eligibility

About

This study will evaluate the safety and efficacy of 2 weeks of topical KD7040 versus placebo in the treatment of postherpetic neuralgia.

Enrollment: 48 estimated patients

Sex: All

Ages: 18 to 85 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: Quadruple Blind

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48 participants in 2 patient groups, including a placebo group

KD7040 topical gel

Experimental group

Treatment:

Drug: KD7040 Topical Gel

Placebo gel

Placebo Comparator group

Treatment:

Drug: Placebo gel