A study to evaluate changes in skin sensation after using a Lidocaine 5 percent medicated plaster in healthy adults and adults with post-herpetic neuralgia

Methodological Validation of the Pinprick Quantitative Sensory Testing Model as a Pharmacodynamic Assay for Detecting Sensory Modulation by Lidocaine 5 percent Medicated Plaster in Healthy Subjects and Adults with Post-Herpetic Neuralgia - NIL

Status

Active, not recruiting

Phases

Phase 2

Study type

Interventional

Source

CTRI

Registry ID

CTRI/2026/06/113103

Enrollment

Registered

2026-06-29

Start date

Unknown

Completion date

Unknown

Last updated

2026-08-03

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Health Condition 1: B022- Zoster with other nervous system involvement

Interventions

Intervention1: Lidocaine: Lidocaine 5% medicated plaster containing 700 mg lidocaine for single topical application as an active sensory modulator Control Intervention1: Vehicle Plaster: A single topi

Eligibility

Inclusion criteria

Inclusion criteria: 1. Approximately 80 adult with post-herpetic neuralgia will be enrolled. 2. History of herpes zoster infection with persistent neuropathic pain for at least 3 months following rash healing. 3. Persistent neuropathic pain 3 months or more after rash healing. 4. Identifiable dermatome suitable for sensory testing. 5. Stable pain intensity during screening period. 6. Stable analgesic therapy.

Exclusion criteria

Exclusion criteria: 1. Unstable neuropathic pain condition. 2. Severe dermatological conditions affecting the application site. 3. Hypersensitivity to lidocaine. 4. Other neurological disorders affecting sensory testing.

Design outcomes

Primary

Measure	Time frame
Change from baseline in evoked pinprick pain intensity following plaster applicationTimepoint: Baseline, 12 hours	—

Secondary

Measure	Time frame
Mechanical pain thresholdTimepoint: Baseline, 12 hours;Stimulus-response slopeTimepoint: Baseline, 12 hours;Area under PD effect curveTimepoint: Up to 12 hours;Change from baseline in spontaneous PHN pain intensityTimepoint: Baseline, 12 hours;Intra-subject variability of responsesTimepoint: Up to 12 hours;Inter-observer reproducibilityTimepoint: Up to 12 hours;Correlation between evoked pain and spontaneous painTimepoint: Baseline, 12 hours	—

Measure

Time frame

Mechanical pain thresholdTimepoint: Baseline, 12 hours;Stimulus-response slopeTimepoint: Baseline, 12 hours;Area under PD effect curveTimepoint: Up to 12 hours;Change from baseline in spontaneous PHN pain intensityTimepoint: Baseline, 12 hours;Intra-subject variability of responsesTimepoint: Up to 12 hours;Inter-observer reproducibilityTimepoint: Up to 12 hours;Correlation between evoked pain and spontaneous painTimepoint: Baseline, 12 hours

—

Countries

India

Contacts

Public ContactDr Santwana Chandrakar

D Y Patil Medical College and Hospital

santwanachandrakar@gmail.com9820505489

Outcome results

None listed

Source: CTRI (via WHO ICTRP) · Data processed: Aug 10, 2026