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

NCT ID: NCT00622440

Last Updated: 2020-04-24

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE2
• Total Enrollment: 70 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2008-05-14
• Study Completion Date: 2012-12-12

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 neoplasia).

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. 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.

Conditions

Anus Neoplasms

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: TRIPLE

Study Groups

1

Group Type: ACTIVE_COMPARATOR

AIJP (Arnebia Indigo Jade Pearl)

Intervention Type: DRUG

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

2

Group Type: PLACEBO_COMPARATOR

Placebo

Intervention Type: DRUG

Placebo twice daily for 48 weeks.

Interventions

AIJP (Arnebia Indigo Jade Pearl)

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

Intervention Type: DRUG

Placebo

Placebo twice daily for 48 weeks.

Intervention Type: DRUG

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 99 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Spring Wind Herbs

UNKNOWN

Sponsor Role: collaborator

University of California, San Francisco

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Misha R Cohen, OMD, LAc

Role: PRINCIPAL_INVESTIGATOR

Chicken Soup Chinese Medicine

Naomi Jay, PhD, FNP

Role: PRINCIPAL_INVESTIGATOR

University of California, San Francisco

Locations

University of California, San Francisco

San Francisco, California, United States

Countries

United States

Related Links

http://www.ucsfhealth.org/adult/medical_services/cancer/cr/conditions/anal/signs.html

General information about HPV, dysplasia, and anal cancer. The website also includes a list of providers of high-resolution anoscopy (HRA).

Other Identifiers

P-07-020

Identifier Type: OTHER_GRANT

Identifier Source: secondary_id

NCI-2011-03238

Identifier Type: REGISTRY

Identifier Source: secondary_id

07501

Identifier Type: -

Identifier Source: org_study_id