Effective Sensitizing Dose of a Gelled Immunomodulating Topical Composition

a topical composition and gel technology, applied in the direction of biocide, drug composition, antibody medical ingredients, etc., can solve the problems of high recurrence rate, cancerous cell recurrence, and difficult management of in-transit disease, so as to reduce tumor growth rate, reduce tumor mass, and eliminate residual disease

a topical composition and gel technology, applied in the direction of biocide, drug composition, antibody medical ingredients, etc., can solve the problems of high recurrence rate, cancerous cell recurrence, and difficult management of in-transit disease, so as to reduce tumor growth rate, reduce tumor mass, and eliminate residual disease

US20110268761A1Inactive Publication Date: 2011-11-03HAPTEN PHARMA
3 Cites 32 Cited by

Examples

Experimental program
Comparison scheme
Effect test

experimental examples

[0157]The invention is further described in detail by reference to the following experimental examples. These examples are provided for purposes of illustration only, and are not intended to be limiting unless otherwise specified. Thus, the invention should in no way be construed as being limited to the following examples, but rather, should be construed to encompass any and all variations which become evident as a result of the teaching provided herein.

example 1

Low Dose Sensitization of DPCP for the Treatment of Warts

[0158]Patients were initially sensitized with 0.4% DPCP gel at the primary wart site. Approximately 14 days later and weekly thereafter for various periods, a challenge dose is then applied. A challenge dose of 0.04% DPCP was employed. The DPCP used was incorporated in a unique blend of surfactants, a viscosity agent, and a preservative. See Table 1 and 2.

TABLE 10.4% DPCP sensitizing dose%1000 gram batchDiphenylcyclopropenone0.404.0Butylated hydroxytoluene NF0.020.2Polysorbate 80 NF49.79497.9Isopropyl myristate NF49.79497.9

TABLE 20.04% DPCP challenge dose%1000 gram batchDiphenylcyclopropenone0.0400.40Butylated hydroxytoluene NF0.010.10Polysorbate 80 NF49.975499.75Isopropyl myristate NF49.975499.75

[0159]It was observed that the treatment regimen of 0.4% DPCP sensitizing dose in combination with a challenge dose of 0.04% DPCP exhibited at least two benefits. First, the treatment regimen using a low sensitizing dose of 0.04% DPCP...

example 2

Low Dose Sensitization of DPCP for the Treatment of Verruca Conditions

[0178]Institutional review board approval was obtained for this study, which was performed using Good Clinical Practice Guidelines and was compliant with the Code of Federal Regulation of the US Food and Drug Administration. A single center, 24 subject, randomized, double-blind, placebo control study using low dose DPCP in a non-volatile vehicle for the treatment of non-genital warts of established.

[0179]Patients are assigned to a treatment or placebo group in a 2:1 fashion. The two study gels are identical in appearance. Both groups are sensitized with 0.1 ml of 0.4% DPCP gel which is applied to the inner arm and washed off in 24 hours. Fourteen days after the sensitization dose, 0.1 ml of 0.04% DPCP gel or placebo is applied to each wart, up to a total of 4 warts, twice a week for 7 consecutive weeks (Day 14, 21, 28, 35, 42, 49, 56, 63). A final follow-up examination is performed on day 77. Patients are assessed...

the structure of the environmentally friendly knitted fabric provided by the present invention; figure 2 Flow chart of the yarn wrapping machine for environmentally friendly knitted fabrics and storage devices; image 3 Is the parameter map of the yarn covering machine
Login to View More

PUM

PropertyMeasurementUnit
Fractionaaaaaaaaaa
Fractionaaaaaaaaaa
Fractionaaaaaaaaaa
Login to View More

Abstract

The present invention relates to compositions and methods of treating warts and other human papilloma virus (HPV) skin infections. The present invention relates to compositions and methods of treating skin cancer.

Description

BACKGROUND OF THE INVENTION[0001]Human papilloma virus (HPV) is a small double-stranded DNA virus that colonizes various stratified epithelia like skin, oral and genital mucosa, and induces the formation of self-limiting benign tumors known as papillomas (warts) or condylomas. Most of these benign tumors naturally regress due to the influence of host immunological defenses. Some HPVs, however, have oncogenic potential and have been associated with certain types of cancers. See, Lorincz et al., Obstetrics & Gynecology, 79:328-337 (1992); Beaudenon et al., Nature, 321:246-249 (1986); and Holloway et al., Gynecol. Onc., 41:123-128 (1991).[0002]Infection with HPV is common. HPV can be transmitted sexually, and it is estimated that 20-80% of sexually active adults have been infected. While a majority of infections are asymptomatic, infection can lead to the development of genital warts (which have a prevalence of about 1-5% among adults) and cancer of the anogenital tract. Another type o...

Claims

the structure of the environmentally friendly knitted fabric provided by the present invention; figure 2 Flow chart of the yarn wrapping machine for environmentally friendly knitted fabrics and storage devices; image 3 Is the parameter map of the yarn covering machine
Login to View More

Application Information

Patent Timeline
03 Nov 2011
Publication
US20110268761A1
IPC
A61K39/12; A61P35/00; A61P31/20; A61K31/122; A61P17/12
CPC
A61K9/0014; A61K31/122; A61K9/06; A61K47/14; A61K47/26; A61K47/10; A61P17/12; A61P31/20
Inventors
LEVIS, WILLIAM R.; KAPLAN, LEONARD L.