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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
University of California, San Francisco
ClinicalTrials.gov Identifier:
NCT00622440
First received: February 13, 2008
Last updated: August 11, 2014
Last verified: August 2014
Results First Received: July 17, 2014  
Study Type: Interventional
Study Design: Allocation: Randomized;   Endpoint Classification: Efficacy Study;   Intervention Model: Parallel Assignment;   Masking: Double Blind (Subject, Caregiver, Investigator);   Primary Purpose: Treatment
Condition: Anus Neoplasms
Interventions: Drug: AIJP (Arnebia Indigo Jade Pearl)
Drug: Placebo

  Participant Flow
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Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
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Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
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Reporting Groups
  Description
AIJP AIJP (Arnebia Indigo Jade Pearl): Participants administer 1/4 teaspoon of AIJP cream twice daily for 48 weeks.
Placebo Placebo: Participants administer 1/4 teaspoon of placebo cream twice daily for 48 weeks.

Participant Flow for 3 periods

Period 1:   Baseline - Week 12 (Treatment)
    AIJP     Placebo  
STARTED     35     35  
COMPLETED     31     34  
NOT COMPLETED     4     1  
Received cream but did not return                 4                 1  

Period 2:   Week 12 - Week 48 (Treatment)
    AIJP     Placebo  
STARTED     31     34  
COMPLETED     28     28  
NOT COMPLETED     3     6  
Lost to Follow-up                 3                 5  
Not evaluable - censored from dataset                 0                 1  

Period 3:   Week 60 (Post-treatment Follow-up Visit)
    AIJP     Placebo  
STARTED     28     28  
COMPLETED     28     27  
NOT COMPLETED     0     1  
Lost to Follow-up                 0                 1  



  Baseline Characteristics
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Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
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Reporting Groups
  Description
AIJP AIJP (Arnebia Indigo Jade Pearl): Participants administer 1/4 teaspoon of AIJP cream twice daily for 48 weeks.
Placebo Placebo: Participants administer 1/4 teaspoon of placebo cream twice daily for 48 weeks.
Total Total of all reporting groups

Baseline Measures
    AIJP     Placebo     Total  
Number of Participants  
[units: participants]
  35     35     70  
Age, Customized  
[units: participants]
     
24-39 years     5     10     15  
40-59 years     25     22     47  
60-74 years     5     3     8  
Gender, Customized  
[units: participants]
     
Men     34     33     67  
Women     1     1     2  
MTF (transgender)     0     1     1  
Ethnicity (NIH/OMB)  
[units: participants]
     
Hispanic or Latino     6     3     9  
Not Hispanic or Latino     29     32     61  
Unknown or Not Reported     0     0     0  
Race (NIH/OMB)  
[units: participants]
     
American Indian or Alaska Native     0     0     0  
Asian     0     4     4  
Native Hawaiian or Other Pacific Islander     2     1     3  
Black or African American     1     4     5  
White     32     24     56  
More than one race     0     2     2  
Unknown or Not Reported     0     0     0  
Region of Enrollment  
[units: participants]
     
United States     35     35     70  



  Outcome Measures
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1.  Primary:   Final Response of Anal High-grade Squamous Intraepithelial Lesions (HSIL)   [ Time Frame: Baseline/screen, Week 48, Week 60 ]

2.  Secondary:   Treatment Adherence   [ Time Frame: 48 weeks ]

3.  Secondary:   Response With >50% Adherence   [ Time Frame: Baseline, 48 weeks, 60 weeks ]

4.  Secondary:   Response With >75% Adherence   [ Time Frame: Baseline, 48 weeks, 60 weeks ]

5.  Secondary:   Estimate Effect Size for Phase 3 Trial   [ Time Frame: Baseline, Week 60 ]
Results not yet posted.   Anticipated Posting Date:   07/2015   Safety Issue:   No


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats
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Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
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  More Information
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Certain Agreements:  
All Principal Investigators ARE employed by the organization sponsoring the study.


Results Point of Contact:  
Name/Title: Naomi Jay, PhD
Organization: UCSF
phone: 415-353-7443
e-mail: Naomi.Jay@ucsf.edu


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
Results First Received: July 17, 2014
Last Updated: August 11, 2014
Health Authority: United States: Food and Drug Administration