Clinical Study on Skin Cancers

A phase II clinical study aimed to show the efficacy and dosing of an existing Class II medical device, Ion Gel ZCM-25®, as a regulatory submission to extend its use as a medicine for treating skin cancers in situ - Basal Cell Carcinoma and Squamous Cell Carcinoma.

Ion Gel ZCM-25 is a drug candidate for topical application in patients diagnosed with Skin Cancers - Basal Cell Carcinoma and Squamous Cell Carcinoma. The study design will determine the efficacy of clinical improvement or resolution of skin cancer in compliance with the regulatory requirements in Mexico and the applicable international Good Clinical Practice (ICH). Good Clinical Practice (ICH E6 R2).

Considering the high safety profile established in Phase I clinical trial and the preclinical experience of Ion Gel ZCM-25, the following design is proposed.

 

Ion Gel ZCM-25®

Phase II, randomized, double-blind clinical study to assess the efficacy and dosing of Ion Gel ZCM-25. The 4-arm clinical study of two or three administrations per day for up to 12 weeks. N= 136 adult patients of both sexes.
Four Study arms:
Fluorouracil (5FU) or 5% Imiquimod Cream
Ion Gel ZCM-25 (2 applications per day) on Basal Cell Carcinoma 
Ion Gel ZCM-25 (3 applications per day) on Squamous Cell Carcinoma
Ion Gel ZCM-0 (placebo)
A total of 136 adult patients of both sexes, between the age of 40 and 70 years, 34 patients per arm. The clinical efficacy of the skin cancers Basal Cell Carcinoma and Squamous Cell Carcinoma will be known.
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