Phase 2
N=70
Treatment of Anal High-grade Squamous Intraepithelial Lesions (HSIL) Through Use of a Chinese Herbal Topical Cream
Anus Neoplasms
Bottom Line
View on ClinicalTrials.gov: NCT00622440 ↗Enrolled (actual)
70
Serious AEs
1.4%
Results posted
Aug 2014
Primary outcome: Primary: Final Response of Anal High-grade Squamous Intraepithelial Lesions (HSIL) — 3; 0; 7; 3 participants — p=.042
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 2
- Interventions
- AIJP (Arnebia Indigo Jade Pearl) (Drug); Placebo (Drug)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- University of California, San Francisco
- Primary completion
- Dec 2012
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Final Response of Anal High-grade Squamous Intraepithelial Lesions (HSIL) |
3; 0; 7; 3; 5; 6 | .042 sig |
| SECONDARY Treatment Adherence |
17; 15; 9; 6; 1; 4 | — |
| SECONDARY Response With >50% Adherence |
3; 0; 7; 3; 4; 5 | — |
| SECONDARY Response With >75% Adherence |
3; 0; 5; 1; 2; 5 | — |
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).
Eligibility Criteria
Inclusion Criteria
- 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 Criteria
- 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
Data sourced from ClinicalTrials.gov (NCT00622440). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.