Neoplasms

Digestive System Diseases

All Conditions

Rare Diseases

Anus Neoplasms

Rectal Neoplasms

Colorectal Neoplasms

Intestinal Neoplasms

Gastrointestinal Neoplasms

Digestive System Neoplasms

Gastrointestinal Diseases

Intestinal Diseases

Anus Diseases

Rectal Diseases

Anal Cancer

Participants will administer their own treatment using 1/4 teaspoon of the cream twice daily for 48 weeks.

AIJP (Arnebia Indigo Jade Pearl)

Placebo

Misha R Cohen, OMD, LAc

Naomi Jay, PhD, FNP

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).

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. AIJP is a topical Chinese herbal cream that has been specifically designed to treat people with the cancer precursor lesions caused by human papillomavirus (HPV). In general, HPV infection is a key factor in development of cervical, anal and vulvar cancers. People with HIV are especially vulnerable to develop anal cancer associated with HPV. It is known that prior to development of anal cancer a person develops a precancerous condition known as a high-grade squamous intraepithelial lesion (HSIL). Treatment of the HSIL can prevent progression to anal cancer. Current therapies for HSIL and anal cancer are highly invasive. A new effective noninvasive topical therapy for precancerous HSIL could have a high impact on prevention of anal cancer.

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

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.

Percent of recommended applications of cream reported in participant diary.

\>75% = Excellent \>50%-75% = Good \>25%-50% = Poor \<25% = Non-adherent

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 Clinical Response (PCR): HSIL on cytology with no HSIL histology, or improvement \>50% in number of lesions with HSIL, or improvement \>50% in lesion size, area, or clinical characteristics (e.g. acetowhite staining, Lugol's staining, or vascular changes improved)

No Response (NR): HSIL present on histology, or improvement ≤ 50% in number, size, area or characteristics.

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 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 on histology, or improvement ≤ 50% in number, size, area or characteristics.

Spring Wind Herbs

University of California, San Francisco

AIJP (Arnebia Indigo Jade Pearl): Participants administer 1/4 teaspoon of AIJP cream twice daily for 48 weeks.

AIJP

Placebo: Participants administer 1/4 teaspoon of placebo cream twice daily for 48 weeks.

Total

24-39 years

40-59 years

60-74 years

Age, Customized

Women

MTF (transgender)

Sex/Gender, Customized

Ethnicity (NIH/OMB)

Race (NIH/OMB)

United States

Region of Enrollment

Naomi Jay, PhD

Final Response of Anal High-grade Squamous Intraepithelial Lesions (HSIL)

Excellent

Good

Poor

Non-adherent

Excludes 7 AIJP participants and 6 Placebo participants who dropped out before week 48. Excludes 1 Placebo participant deemed non-evaluable.

Treatment Adherence

Evaluable participants who finished 48 weeks of treatment and reported \>50% adherence to treatment

Response With >50% Adherence

Evaluable participants who finished 48 weeks of treatement and reported \>75% adherence to treatment

Response With >75% Adherence

Baseline - Week 12 (Treatment)

Week 12 - Week 48 (Treatment)

Week 60 (Post-treatment Follow-up Visit)

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
Treatment of Anal High-grade Squamous Intraepithelial Lesions (HSIL) Through Use of a Chinese Herbal Topical Cream	NCT00622440	Anus Neoplasms	AIJP (Arnebia I... Placebo	18 Years - 99 Years	University of California, San Francisco
Treatment of Anal High-grade Squamous Intraepithelial Lesions (HSIL) Through Use of a Chinese Herbal Topical Cream	NCT00622440	Anus Neoplasms	AIJP (Arnebia I... Placebo	18 Years - 99 Years	University of California, San Francisco
Treatment of Anal High-grade Squamous Intraepithelial Lesions (HSIL) Through Use of a Chinese Herbal Topical Cream	NCT00622440	Anus Neoplasms	AIJP (Arnebia I... Placebo	18 Years - 99 Years	University of California, San Francisco

Spots Global Cancer Trial Database for aijp (arnebia indigo jade pearl)