Treatment of Anal High-grade Squamous Intraepithelial Lesions (HSIL) Through Use of a Chinese Herbal Topical Cream
AIJP
Phase II Study for Treatment of Anal HSIL Through Use of a Chinese Herbal Topical Cream
3 other identifiers
interventional
70
1 country
1
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).
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_2
Started May 2008
Typical duration for phase_2
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
February 13, 2008
CompletedFirst Posted
Study publicly available on registry
February 25, 2008
CompletedStudy Start
First participant enrolled
May 14, 2008
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 12, 2012
CompletedStudy Completion
Last participant's last visit for all outcomes
December 12, 2012
CompletedResults Posted
Study results publicly available
August 12, 2014
CompletedApril 24, 2020
April 1, 2020
4.6 years
February 13, 2008
July 17, 2014
April 14, 2020
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Final Response of Anal High-grade Squamous Intraepithelial Lesions (HSIL)
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.
Baseline, Week 48, and Week 60; up to 60 weeks
Secondary Outcomes (3)
Treatment Adherence
Up to 48 weeks
Response With >50% Adherence
Baseline, Week 48, and Week 60; up to 60 weeks
Response With >75% Adherence
Baseline, Week 48, and Week 60; up to 60 weeks
Study Arms (2)
1
ACTIVE COMPARATOR2
PLACEBO COMPARATORInterventions
Participants will administer their own treatment using 1/4 teaspoon of the cream twice daily for 48 weeks.
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- University of California, San Franciscolead
- Spring Wind Herbscollaborator
Study Sites (1)
University of California, San Francisco
San Francisco, California, 94143, United States
Related Links
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Results Point of Contact
- Title
- Naomi Jay, PhD
- Organization
- University of California, San Francisco
Study Officials
- PRINCIPAL INVESTIGATOR
Misha R Cohen, OMD, LAc
Chicken Soup Chinese Medicine
- PRINCIPAL INVESTIGATOR
Naomi Jay, PhD, FNP
University of California, San Francisco
Publication Agreements
- PI is Sponsor Employee
- Yes
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- RANDOMIZED
- Masking
- TRIPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
February 13, 2008
First Posted
February 25, 2008
Study Start
May 14, 2008
Primary Completion
December 12, 2012
Study Completion
December 12, 2012
Last Updated
April 24, 2020
Results First Posted
August 12, 2014
Record last verified: 2020-04
Data Sharing
- IPD Sharing
- Will not share