VEREGEN Ointment Ref.[11070] Active ingredients: Sinecatechins

The pharmacodynamics of Veregen is unknown.

Systemic exposure to EGCg, EGC, ECg, and EC were evaluated following either topical application of Veregen to subjects with external genital and perianal warts (250 mg applied 3 times a day for 7 days) or following oral ingestion of green tea beverage (500 mL ingested 3 times a day for 7 days). Following topical application of Veregen, plasma concentration of all 4 catechins were below the limit of quantification (<5 ng/mL) on Day 1. After application of Veregen for 7 days, plasma EGC, ECg, and EC concentrations were below the limit of quantification while plasma concentration of EGCg were measurable in 2 out of 20 subjects. The mean maximal plasma concentration (C_max) of EGCg was 10.1 ng/mL and the mean area under the concentration versus time curve (AUC) of EGCg was 52.2 ng*h/mL in these 2 subjects. Oral ingestion of green tea beverage resulted in measurable concentration of EGCg in all subjects on both Day 1 and Day 7, with mean (SD) C_max of 23.0 (12.0) ng/mL and AUC of 104.6 (39.0) ng*h/mL on Day 7.

In an oral (gavage) carcinogenicity study, sinecatechins was administered daily for 26 weeks to p53 transgenic mice at doses up to 500 mg/kg/day. Treatment with sinecatechins was not associated with an increased incidence of either neoplastic or non-neoplastic lesions in the organs and tissues examined. Veregen has not been evaluated in a dermal carcinogenicity study.

Sinecatechins was negative in the Ames test, in vivo rat micronucleus assay, UDS test, and transgenic mouse mutation assay, but positive in the mouse lymphoma mutation assay.

Daily vaginal administration of Veregen to rats from Day 4 before mating and throughout mating until Day 17 of gestation did not cause adverse effects on mating performance and fertility at doses up to 0.15 mL/rat/day.

Two randomized, double-blind, vehicle-controlled trials were performed to investigate the safety and efficacy of Veregen in the treatment of immunocompetent subjects 18 years of age and older with external genital and perianal warts. The subjects applied the ointment 3 times daily for up to 16 weeks or until complete clearance of all warts (baseline and new warts occurring during treatment).

Over both trials the median baseline wart area was 51 mm² (range 12 to 585 mm²), and the median baseline number of warts was 6 (range 2 to 30).

The primary efficacy outcome measure was the response rate defined as the proportion of subjects with complete clinical (visual) clearance of all external genital and perianal warts (baseline and new) by week 16, presented in Tables 2 and 3 for all randomized subjects dispensed medication.

Table 2. Efficacy by Region:

Table 3. Efficacy by Gender:

Median time to complete wart clearance was 16 weeks and 10 weeks, respectively, in the two phase 3 clinical trials.

The rate of recurrence of external genital and perianal warts 12 weeks after completion of treatment in subjects with complete clearance is 6.8% (14/206) for those treated with Veregen and 5.8% (4/69) for those treated with vehicle.