Treatment of Anal High-grade Squamous Intraepithelial Lesions (HSIL) Through Use of a Chinese Herbal Topical Cream (AIJP)
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Purpose
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).
| Condition | Intervention | Phase |
|---|---|---|
|
Anus Neoplasms |
Drug: AIJP (Arnebia Indigo Jade Pearl) Drug: Placebo |
Phase 2 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Efficacy Study Intervention Model: Parallel Assignment Masking: Double Blind (Subject, Caregiver, Investigator) Primary Purpose: Treatment |
| Official Title: | Phase II Study for Treatment of Anal HSIL Through Use of a Chinese Herbal Topical Cream |
- Pathologic response (progression, no change, or regression) of anal HSIL to treatment with the topical cream versus treatment with placebo [ Time Frame: Clinical assessment at screen, week 24, week 48, and follow up at week 60 ] [ Designated as safety issue: No ]
- To evaluate treatment adherence and drop-out rates, and obtain effect size for Phase 3 trial [ Time Frame: Week 24, week 48, and week 60 ] [ Designated as safety issue: No ]
| Estimated Enrollment: | 70 |
| Study Start Date: | March 2008 |
| Estimated Study Completion Date: | December 2012 |
| Estimated Primary Completion Date: | December 2012 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
| Active Comparator: 1 |
Drug: AIJP (Arnebia Indigo Jade Pearl)
Participants will administer their own treatment using 1/4 teaspoon of the cream twice daily for 48 weeks.
|
| Placebo Comparator: 2 |
Drug: Placebo
Placebo twice daily for 48 weeks.
|
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.
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
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
Contacts and Locations| United States, California | |
| UCSF Mt. Zion Medical Center, 1600 Divisadero St., Box 1699 | |
| San Francisco, California, United States, 94143-1699 | |
| Principal Investigator: | Misha R Cohen, OMD, LAc | Institute for Health and Aging, UCSF School of Nursing |
More Information
Additional Information:
No publications provided
| Responsible Party: | University of California, San Francisco |
| ClinicalTrials.gov Identifier: | NCT00622440 History of Changes |
| Other Study ID Numbers: | CCRC 5031, CC # 07501, CTRF Grant # P-07-020 |
| Study First Received: | February 13, 2008 |
| Last Updated: | March 19, 2012 |
| Health Authority: | United States: Food and Drug Administration |
Keywords provided by University of California, San Francisco:
|
HSIL HGAIN AIN neoplasia |
dysplasia TCM Traditional Chinese Medicine |
Additional relevant MeSH terms:
|
Anus Neoplasms Neoplasms Uterine Cervical Dysplasia Rectal Neoplasms Colorectal Neoplasms Intestinal Neoplasms Gastrointestinal Neoplasms Digestive System Neoplasms Neoplasms by Site |
Digestive System Diseases Gastrointestinal Diseases Intestinal Diseases Anus Diseases Rectal Diseases Precancerous Conditions Uterine Cervical Diseases Uterine Diseases Genital Diseases, Female |
ClinicalTrials.gov processed this record on May 19, 2013