Status:
COMPLETED
Treatment of Anal High-grade Squamous Intraepithelial Lesions (HSIL) Through Use of a Chinese Herbal Topical Cream
Lead Sponsor:
University of California, San Francisco
Collaborating Sponsors:
Spring Wind Herbs
Conditions:
Anus Neoplasms
Eligibility:
All Genders
18-99 years
Phase:
PHASE2
Brief 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 n...
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....
Eligibility Criteria
Inclusion
- 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
Exclusion
- 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
Key Trial Info
Start Date :
May 14 2008
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 12 2012
Estimated Enrollment :
70 Patients enrolled
Trial Details
Trial ID
NCT00622440
Start Date
May 14 2008
End Date
December 12 2012
Last Update
April 24 2020
Active Locations (1)
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1
University of California, San Francisco
San Francisco, California, United States, 94143