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

Completed · Phase 2 · Has a placebo group

Conditions studied: Anus Neoplasms

In brief

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).

Key facts

Study ID

NCT00622440

Run by

University of California, San Francisco

People needed

70

Starts

2008-05-14

Expected to finish

2012-12-12

Last updated by the study team

2020-04-24

Who can join

Age: 18 and older, up to 99. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Anal HSIL confirmed by biopsy no more than 30 days prior to entry
• Anal HSIL deemed not amenable to therapy or participant declines routine ablative therapy
• HIV positive
• Stable HIV treatment regimen for at least 8 weeks prior to entry
• At least 18 years of age
• Women of childbearing potential must use contraception
• Platelet count above 70,000/mm3 within 30 days prior to entry
• ANC greater or equal to 1000/mm3 within 30 days prior to entry
• Creatinine less then or equal to 1.5 times ULN within 30 days prior to entry
• AST and ALT less than or equal to 3 times ULN within 30 days prior to entry

You may not qualify if…

• Prior history of invasive anal, cervical, vaginal, or vulvar cancer
• Pregnancy or lactation and breast-feeding
• Must not participate in a conception process including sperm donation
• Medical or psychiatric illness that precludes ability to give informed consent or is likely to interfere with ability to comply with protocol
• Known allergy to any topical cream components
• Patients with lesions clinically suspicious per HRA examiner for early progression (less than one year) to anal cancer

Where it is running

• University of California, San Francisco — San Francisco, California, United States

Full record on ClinicalTrials.gov

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