NCT00622440

Treatment of Anal High-grade Squamous Intraepithelial Lesions (HSIL) Through Use of a Chinese Herbal Topical Cream

Phase II Study for Treatment of Anal HSIL Through Use of a Chinese Herbal Topical Cream

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 70 (actual)
• Sponsor: University of California, San Francisco · Academic / Other
• Sex: All
• Age: 18 Years – 99 Years
• Healthy volunteers: Not accepted

Summary

The purpose of this study is to find out if a Chinese herbal cream is effective in treating HSIL (high-grade squamous intraepithelial lesions, also known as HGAIN, or high-grade anal intraepithelial neoplasia).

Detailed description

The purpose of this study is to test a new noninvasive topical cream, AIJP (Arnebia Indigo Jade Pearl), for treatment of precancerous anal lesions in order to prevent their progression to anal cancer. AIJP is a topical Chinese herbal cream that has been specifically designed to treat people with the cancer precursor lesions caused by human papillomavirus (HPV). In general, HPV infection is a key factor in development of cervical, anal and vulvar cancers. People with HIV are especially vulnerable to develop anal cancer associated with HPV. It is known that prior to development of anal cancer a person develops a precancerous condition known as a high-grade squamous intraepithelial lesion (HSIL). Treatment of the HSIL can prevent progression to anal cancer. Current therapies for HSIL and anal cancer are highly invasive. A new effective noninvasive topical therapy for precancerous HSIL could have a high impact on prevention of anal cancer.

Conditions

• Anus Neoplasms

Interventions

Type	Name	Description
DRUG	AIJP (Arnebia Indigo Jade Pearl)	Participants will administer their own treatment using 1/4 teaspoon of the cream twice daily for 48 weeks.
DRUG	Placebo	Placebo twice daily for 48 weeks.

Timeline

• Start date: 2008-05-14
• Primary completion: 2012-12-12
• Completion: 2012-12-12
• First posted: 2008-02-25
• Last updated: 2020-04-24
• Results posted: 2014-08-12

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study