Clinical trial · Interventional
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
NCT00622440CI-TRIAL-00044801AIJPcompletedPhase 2Results postedClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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).
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Anus Neoplasms | Anal Neoplasm | ALIAS | 0.90 |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| AIJP (Arnebia Indigo Jade Pearl) | Drug | — | UNRESOLVED |
| Placebo | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- ACTIVE_COMPARATOR
- label
- 1
- interventionNames
- Drug: AIJP (Arnebia Indigo Jade Pearl)
- type
- PLACEBO_COMPARATOR
- label
- 2
- interventionNames
- Drug: Placebo
Primary outcomes (1)
- measure
- Final Response of Anal High-grade Squamous Intraepithelial Lesions (HSIL)
- timeFrame
- Baseline, Week 48, and Week 60; up to 60 weeks
- description
- Response assessed 12 weeks after treatment. Late Clinical Response (LCR): HSIL present at week 48 but none at week 60, with two independent reviews in agreement that HSIL absent at week 60. Complete response (CR): No HSIL on histology or cytology at weeks 48 or 60 (caveat: if HSIL at week 60, blinded chart notes and photographs were reviewed by two clinicians, and decision was reached by agreement or consensus whether HSIL had been missed at week 48. Cases that reviewers independently agreed had not been missed at week 48 were considered true recurrences) Partial Clinical Response (PCR): HSIL on cytology with no HSIL histology, or improvement \>50% in the number of lesions with HSIL, or an improvement \>50% in lesion size, area, or clinical characteristics (e.g. acetowhite staining, Lugol's staining, or vascular changes were improved) No Response (NR): HSIL present at weeks 48 \& 60 on histology, or improvement ≤ 50% in number, size, area or characteristics.
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
- Maximum age
- 99 Years
Show eligibility criteria text
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
References
Publications (0)
Data not yet available
No reference posted for this study.