Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT00622440
Recruitment Status : Completed
First Posted : February 25, 2008
Results First Posted : August 12, 2014
Last Update Posted : August 15, 2014
Sponsor:
Information provided by (Responsible Party):
University of California, San Francisco

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Triple (Participant, Care Provider, Investigator);   Primary Purpose: Treatment
Condition Anus Neoplasms
Interventions Drug: AIJP (Arnebia Indigo Jade Pearl)
Drug: Placebo
Enrollment 70
Recruitment Details  
Pre-assignment Details  
Arm/Group Title AIJP Placebo
Hide Arm/Group Description AIJP (Arnebia Indigo Jade Pearl): Participants administer 1/4 teaspoon of AIJP cream twice daily for 48 weeks. Placebo: Participants administer 1/4 teaspoon of placebo cream twice daily for 48 weeks.
Period Title: Baseline - Week 12 (Treatment)
Started 35 35
Completed 31 34
Not Completed 4 1
Reason Not Completed
Received cream but did not return             4             1
Period Title: Week 12 - Week 48 (Treatment)
Started 31 34
Completed 28 28
Not Completed 3 6
Reason Not Completed
Lost to Follow-up             3             5
Not evaluable - censored from dataset             0             1
Period Title: Week 60 (Post-treatment Follow-up Visit)
Started 28 28
Completed 28 27
Not Completed 0 1
Reason Not Completed
Lost to Follow-up             0             1
Arm/Group Title AIJP Placebo Total
Hide Arm/Group Description AIJP (Arnebia Indigo Jade Pearl): Participants administer 1/4 teaspoon of AIJP cream twice daily for 48 weeks. Placebo: Participants administer 1/4 teaspoon of placebo cream twice daily for 48 weeks. Total of all reporting groups
Overall Number of Baseline Participants 35 35 70
Hide Baseline Analysis Population Description
[Not Specified]
Age, Customized  
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 35 participants 35 participants 70 participants
24-39 years 5 10 15
40-59 years 25 22 47
60-74 years 5 3 8
Sex/Gender, Customized  
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 35 participants 35 participants 70 participants
Men 34 33 67
Women 1 1 2
MTF (transgender) 0 1 1
Ethnicity (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 35 participants 35 participants 70 participants
Hispanic or Latino
6
  17.1%
3
   8.6%
9
  12.9%
Not Hispanic or Latino
29
  82.9%
32
  91.4%
61
  87.1%
Unknown or Not Reported
0
   0.0%
0
   0.0%
0
   0.0%
Race (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 35 participants 35 participants 70 participants
American Indian or Alaska Native
0
   0.0%
0
   0.0%
0
   0.0%
Asian
0
   0.0%
4
  11.4%
4
   5.7%
Native Hawaiian or Other Pacific Islander
2
   5.7%
1
   2.9%
3
   4.3%
Black or African American
1
   2.9%
4
  11.4%
5
   7.1%
White
32
  91.4%
24
  68.6%
56
  80.0%
More than one race
0
   0.0%
2
   5.7%
2
   2.9%
Unknown or Not Reported
0
   0.0%
0
   0.0%
0
   0.0%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
United States Number Analyzed 35 participants 35 participants 70 participants
35 35 70
1.Primary Outcome
Title Final Response of Anal High-grade Squamous Intraepithelial Lesions (HSIL)
Hide Description

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.

Time Frame Baseline/screen, Week 48, Week 60
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title AIJP Placebo
Hide Arm/Group Description:
AIJP (Arnebia Indigo Jade Pearl): Participants administer 1/4 teaspoon of AIJP cream twice daily for 48 weeks.
Placebo: Participants administer 1/4 teaspoon of placebo cream twice daily for 48 weeks.
Overall Number of Participants Analyzed 28 28
Measure Type: Number
Unit of Measure: participants
LCR 3 0
CR 7 3
PCR 5 6
NR 13 19
2.Secondary Outcome
Title Treatment Adherence
Hide Description

Percent of recommended applications of cream reported in participant diary.

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

Time Frame 48 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
Excludes 7 AIJP participants and 6 Placebo participants who dropped out before week 48. Excludes 1 Placebo participant deemed non-evaluable.
Arm/Group Title AIJP Placebo
Hide Arm/Group Description:
AIJP (Arnebia Indigo Jade Pearl): Participants administer 1/4 teaspoon of AIJP cream twice daily for 48 weeks.
Placebo: Participants administer 1/4 teaspoon of placebo cream twice daily for 48 weeks.
Overall Number of Participants Analyzed 28 28
Measure Type: Number
Unit of Measure: participants
Excellent 17 15
Good 9 6
Poor 1 4
Non-adherent 1 3
3.Secondary Outcome
Title Estimate Effect Size for Phase 3 Trial
Hide Description Secondary outcome stated in original protocol posting
Time Frame Baseline, Week 60
Outcome Measure Data Not Reported
4.Secondary Outcome
Title Response With >50% Adherence
Hide Description

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.

Time Frame Baseline, 48 weeks, 60 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
Evaluable participants who finished 48 weeks of treatement and reported >50% adherence to treatment
Arm/Group Title AIJP Placebo
Hide Arm/Group Description:
AIJP (Arnebia Indigo Jade Pearl): Participants administer 1/4 teaspoon of AIJP cream twice daily for 48 weeks.
Placebo: Participants administer 1/4 teaspoon of placebo cream twice daily for 48 weeks.
Overall Number of Participants Analyzed 26 21
Measure Type: Number
Unit of Measure: participants
LCR 3 0
CR 7 3
PCR 4 5
NR 12 13
5.Secondary Outcome
Title Response With >75% Adherence
Hide Description

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.

Time Frame Baseline, 48 weeks, 60 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
Evaluable participants who finished 48 weeks of treatement and reported >75% adherence to treatment
Arm/Group Title AIJP Placebo
Hide Arm/Group Description:
AIJP (Arnebia Indigo Jade Pearl): Participants administer 1/4 teaspoon of AIJP cream twice daily for 48 weeks.
Placebo: Participants administer 1/4 teaspoon of placebo cream twice daily for 48 weeks.
Overall Number of Participants Analyzed 17 15
Measure Type: Number
Unit of Measure: participants
LCR 3 0
CR 5 1
PCR 2 5
NR 7 9
Time Frame 60 Weeks
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title AIJP Placebo
Hide Arm/Group Description AIJP (Arnebia Indigo Jade Pearl): Participants administer 1/4 teaspoon of AIJP cream twice daily for 48 weeks. Placebo: Participants administer 1/4 teaspoon of placebo cream twice daily for 48 weeks.
All-Cause Mortality
AIJP Placebo
Affected / at Risk (%) Affected / at Risk (%)
Total   --/--   --/-- 
Show Serious Adverse Events Hide Serious Adverse Events
AIJP Placebo
Affected / at Risk (%) Affected / at Risk (%)
Total   0/35 (0.00%)   1/35 (2.86%) 
Neoplasms benign, malignant and unspecified (incl cysts and polyps)     
Perianal cancer  [1]  0/35 (0.00%)  1/35 (2.86%) 
Indicates events were collected by systematic assessment
[1]
Superficially invasive cancer possibly present at baseline; participant non-evaluable for study outcomes
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
AIJP Placebo
Affected / at Risk (%) Affected / at Risk (%)
Total   0/35 (0.00%)   0/35 (0.00%) 
Certain Agreements
All Principal Investigators ARE employed by the organization sponsoring the study.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Naomi Jay, PhD
Organization: UCSF
Phone: 415-353-7443
EMail: Naomi.Jay@ucsf.edu
Layout table for additonal information
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
First Submitted: February 13, 2008
First Posted: February 25, 2008
Results First Submitted: July 17, 2014
Results First Posted: August 12, 2014
Last Update Posted: August 15, 2014