NCT00622440: AIJP

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

Completed Phase 2 Results posted Last updated 24 April 2020

What this trial tests

Phase 2 trial testing AIJP (Arnebia Indigo Jade Pearl) in Anus Neoplasms in 70 participants. Completed in 12 December 2012.

Timeline

14 May 2008

Primary endpoint
12 December 2012

12 December 2012

Quick facts

Lead sponsor	University of California, San Francisco
Phase	Phase 2
Status	Completed
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	triple
Primary purpose	treatment
Enrollment	70
Start date	14 May 2008
Primary completion	12 December 2012
Estimated completion	12 December 2012
Sites	1 location across United States

Drugs / interventions tested

• AIJP (Arnebia Indigo Jade Pearl) — full drug profile →
• Placebo

Conditions studied

• Anus Neoplasms — all drugs for Anus Neoplasms →

Sponsor

University of California, San Francisco

Who can join

Adults 18 to 99, any sex, with Anus Neoplasms. Patients with the condition only — healthy volunteers not accepted.

Results — posted to ClinicalTrials.gov

Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.

Final Response of Anal High-grade Squamous Intraepithelial Lesions (HSIL) Primary · Baseline, Week 48, and Week 60; up to 60 weeks

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): HS

LCR

Group	Value	95% CI
AIJP	3
Placebo	0

CR

Group	Value	95% CI
AIJP	7
Placebo	3

PCR

Group	Value	95% CI
AIJP	5
Placebo	6

NR

Group	Value	95% CI
AIJP	13
Placebo	19

Treatment Adherence Secondary · Up to 48 weeks

Percent of recommended applications of cream reported in participant diary. \>75% = Excellent \>50%-75% = Good \>25%-50% = Poor \<25% = Non-adherent

Excellent

Group	Value	95% CI
AIJP	17
Placebo	15

Good

Group	Value	95% CI
AIJP	9
Placebo	6

Poor

Group	Value	95% CI
AIJP	1
Placebo	4

Non-adherent

Group	Value	95% CI
AIJP	1
Placebo	3

Response With >50% Adherence Secondary · Baseline, Week 48, and Week 60; up to 60 weeks

Response assessed 12 weeks after treatment (week 60), by treatment adherence assessed at 48 weeks. Late Clinical Response (LCR): HSIL present at week 48 but none at week 60; two independent reviews agree 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 reviewed by two clinicians, with decision 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 Clini

LCR

Group	Value	95% CI
AIJP	3
Placebo	0

CR

Group	Value	95% CI
AIJP	7
Placebo	3

PCR

Group	Value	95% CI
AIJP	4
Placebo	5

NR

Group	Value	95% CI
AIJP	12
Placebo	13

Response With >75% Adherence Secondary · Baseline, Week 48, and Week 60; up to 60 weeks

Response assessed 12 weeks after treatment (week 60), by treatment adherence assessed at 48 weeks. Late Clinical Response (LCR): HSIL present at week 48 but none at week 60; two independent reviews agree that HSIL absent at week 60. Complete response (CR): No HSIL on histology or cytology (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 Cl

LCR

Group	Value	95% CI
AIJP	3
Placebo	0

CR

Group	Value	95% CI
AIJP	5
Placebo	1

PCR

Group	Value	95% CI
AIJP	2
Placebo	5

NR

Group	Value	95% CI
AIJP	7
Placebo	9

Adverse events — posted to ClinicalTrials.gov

Time frame: 60 Weeks. Reporting threshold: 5%. Adverse-event reports describe events observed during the trial — not all are caused by the drug.

AIJP

Serious: 0/35 (0%)

Deaths: 0/35

Placebo

Serious: 1/35 (3%)

Deaths: 0/35

Serious adverse events (1 terms)

Reaction	System	AIJP	Placebo
Perianal cancer	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	—	—

Most-reported serious reactions: Perianal cancer.

Data from ClinicalTrials.gov NCT00622440 adverse events section.

Sponsor's own description

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).

Publications & conference data

2 peer-reviewed publications reference this trial (live from Europe PMC):

1. Interventions for anal canal intraepithelial neoplasia.
   Macaya A, Muñoz-Santos C, Balaguer A, Barberà MJ. · · 2012 · cited 27× · PMID 23235673 · DOI 10.1002/14651858.cd009244.pub2
2. Current Characteristics of Herbal Medicine Interventions for Cancer on Clinical Databases: A Cross-Sectional Study.
   Youn BY, Kim JH, Jo YK, Yoon S, et al · · 2023 · cited 6× · PMID 38099482 · DOI 10.1177/15347354231218255