Phase 2a Study Hydrocortisone-Lidocaine combination – Hemorrhoids

Phase 2a Study*

In a randomized, double-blind study, 210 patients with Grade I and II hemorrhoids were treated twice daily for 14 days. Patients received either a placebo or one of six active drug treatments, with two concentrations each of hydrocortisone, lidocaine, or a hydrocortisone-lidocaine combination. Patients kept a diary of their symptoms. Additionally, there were four physician assessments, during which patients were evaluated on the Global Score of Disease Severity (GSDS) scale as well as on the individual signs and symptoms of hemorrhoids, such as bleeding, pruritus, overall pain and discomfort, and time to the onset of symptom relief.

Level Improvement Global Severity

Within the first few days of treatment, the highest concentration of the hydrocortisone-lidocaine combination was directionally superior to the placebo as measured by the number of subjects experiencing a minimum of two levels improvement from baseline according to the GSDS scale. This study was not powered to obtain statistical significance; however, the data suggest that the combination product may also perform better than hydrocortisone or lidocaine alone.

Pruritus (Severe Itching)

The hydrocortisone-lidocaine combination seemed to achieve 88.9% greater relief of pruritus at Day 2 as compared to any of its components alone.*

Pain and Discomfort

The hydrocortisone-lidocaine combination seemed to achieve 85.7% greater relief of pain and discomfort at Day 2 as compared to any of its components alone.*

* Study was not powered to show statistical significance; its purpose was to inform future study designs.

CITI-001 (Hydro-Lido) was the first steroid-anesthetic combination product tested in a clinical trial for symptomatic relief of hemorrhoids.  The new formulation, CITI-002, will combine lidocaine with the higher-potency corticosteroid for symptomatic relief of the pain and discomfort of hemorrhoids.  This change should improve the efficacy further while also providing faster onset of relief.  While not used in combination in currently-marketed products, the proposed corticosteroid is included as an FDA-approved topical product to treat a variety of dermatological disorders.