Trial Outcomes & Findings for Treatment of Anal High-grade Squamous Intraepithelial Lesions (HSIL) Through Use of a Chinese Herbal Topical Cream (NCT NCT00622440)
NCT ID: NCT00622440
Last Updated: 2020-04-24
Results Overview
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.
COMPLETED
PHASE2
70 participants
Baseline, Week 48, and Week 60; up to 60 weeks
2020-04-24
Participant Flow
Participant milestones
| Measure |
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.
|
|---|---|---|
|
Baseline - Week 12 (Treatment)
STARTED
|
35
|
35
|
|
Baseline - Week 12 (Treatment)
COMPLETED
|
31
|
34
|
|
Baseline - Week 12 (Treatment)
NOT COMPLETED
|
4
|
1
|
|
Week 12 - Week 48 (Treatment)
STARTED
|
31
|
34
|
|
Week 12 - Week 48 (Treatment)
COMPLETED
|
28
|
28
|
|
Week 12 - Week 48 (Treatment)
NOT COMPLETED
|
3
|
6
|
|
Week 60 (Post-treatment Follow-up Visit)
STARTED
|
28
|
28
|
|
Week 60 (Post-treatment Follow-up Visit)
COMPLETED
|
28
|
27
|
|
Week 60 (Post-treatment Follow-up Visit)
NOT COMPLETED
|
0
|
1
|
Reasons for withdrawal
| Measure |
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.
|
|---|---|---|
|
Baseline - Week 12 (Treatment)
Received cream but did not return
|
4
|
1
|
|
Week 12 - Week 48 (Treatment)
Lost to Follow-up
|
3
|
5
|
|
Week 12 - Week 48 (Treatment)
Not evaluable - censored from dataset
|
0
|
1
|
|
Week 60 (Post-treatment Follow-up Visit)
Lost to Follow-up
|
0
|
1
|
Baseline Characteristics
Treatment of Anal High-grade Squamous Intraepithelial Lesions (HSIL) Through Use of a Chinese Herbal Topical Cream
Baseline characteristics by cohort
| Measure |
AIJP
n=35 Participants
AIJP (Arnebia Indigo Jade Pearl): Participants administer 1/4 teaspoon of AIJP cream twice daily for 48 weeks.
|
Placebo
n=35 Participants
Placebo: Participants administer 1/4 teaspoon of placebo cream twice daily for 48 weeks.
|
Total
n=70 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Customized
24-39 years
|
5 participants
n=5 Participants
|
10 participants
n=7 Participants
|
15 participants
n=5 Participants
|
|
Age, Customized
40-59 years
|
25 participants
n=5 Participants
|
22 participants
n=7 Participants
|
47 participants
n=5 Participants
|
|
Age, Customized
60-74 years
|
5 participants
n=5 Participants
|
3 participants
n=7 Participants
|
8 participants
n=5 Participants
|
|
Sex/Gender, Customized
Men
|
34 participants
n=5 Participants
|
33 participants
n=7 Participants
|
67 participants
n=5 Participants
|
|
Sex/Gender, Customized
Women
|
1 participants
n=5 Participants
|
1 participants
n=7 Participants
|
2 participants
n=5 Participants
|
|
Sex/Gender, Customized
MTF (transgender)
|
0 participants
n=5 Participants
|
1 participants
n=7 Participants
|
1 participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
6 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
9 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
29 Participants
n=5 Participants
|
32 Participants
n=7 Participants
|
61 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=5 Participants
|
4 Participants
n=7 Participants
|
4 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
2 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
3 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Black or African American
|
1 Participants
n=5 Participants
|
4 Participants
n=7 Participants
|
5 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
32 Participants
n=5 Participants
|
24 Participants
n=7 Participants
|
56 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
35 participants
n=5 Participants
|
35 participants
n=7 Participants
|
70 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Baseline, Week 48, and Week 60; up to 60 weeksResponse 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.
Outcome measures
| Measure |
AIJP
n=28 Participants
AIJP (Arnebia Indigo Jade Pearl): Participants administer 1/4 teaspoon of AIJP cream twice daily for 48 weeks.
|
Placebo
n=28 Participants
Placebo: Participants administer 1/4 teaspoon of placebo cream twice daily for 48 weeks.
|
|---|---|---|
|
Final Response of Anal High-grade Squamous Intraepithelial Lesions (HSIL)
LCR
|
3 participants
|
0 participants
|
|
Final Response of Anal High-grade Squamous Intraepithelial Lesions (HSIL)
CR
|
7 participants
|
3 participants
|
|
Final Response of Anal High-grade Squamous Intraepithelial Lesions (HSIL)
PCR
|
5 participants
|
6 participants
|
|
Final Response of Anal High-grade Squamous Intraepithelial Lesions (HSIL)
NR
|
13 participants
|
19 participants
|
SECONDARY outcome
Timeframe: Up to 48 weeksPopulation: Excludes 7 AIJP participants and 6 Placebo participants who dropped out before week 48. Excludes 1 Placebo participant deemed non-evaluable.
Percent of recommended applications of cream reported in participant diary. \>75% = Excellent \>50%-75% = Good \>25%-50% = Poor \<25% = Non-adherent
Outcome measures
| Measure |
AIJP
n=28 Participants
AIJP (Arnebia Indigo Jade Pearl): Participants administer 1/4 teaspoon of AIJP cream twice daily for 48 weeks.
|
Placebo
n=28 Participants
Placebo: Participants administer 1/4 teaspoon of placebo cream twice daily for 48 weeks.
|
|---|---|---|
|
Treatment Adherence
Excellent
|
17 participants
|
15 participants
|
|
Treatment Adherence
Good
|
9 participants
|
6 participants
|
|
Treatment Adherence
Poor
|
1 participants
|
4 participants
|
|
Treatment Adherence
Non-adherent
|
1 participants
|
3 participants
|
SECONDARY outcome
Timeframe: Baseline, Week 48, and Week 60; up to 60 weeksPopulation: Evaluable participants who finished 48 weeks of treatment and reported \>50% adherence to treatment
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.
Outcome measures
| Measure |
AIJP
n=26 Participants
AIJP (Arnebia Indigo Jade Pearl): Participants administer 1/4 teaspoon of AIJP cream twice daily for 48 weeks.
|
Placebo
n=21 Participants
Placebo: Participants administer 1/4 teaspoon of placebo cream twice daily for 48 weeks.
|
|---|---|---|
|
Response With >50% Adherence
LCR
|
3 participants
|
0 participants
|
|
Response With >50% Adherence
NR
|
12 participants
|
13 participants
|
|
Response With >50% Adherence
CR
|
7 participants
|
3 participants
|
|
Response With >50% Adherence
PCR
|
4 participants
|
5 participants
|
SECONDARY outcome
Timeframe: Baseline, Week 48, and Week 60; up to 60 weeksPopulation: Evaluable participants who finished 48 weeks of treatement and reported \>75% adherence to treatment
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.
Outcome measures
| Measure |
AIJP
n=17 Participants
AIJP (Arnebia Indigo Jade Pearl): Participants administer 1/4 teaspoon of AIJP cream twice daily for 48 weeks.
|
Placebo
n=15 Participants
Placebo: Participants administer 1/4 teaspoon of placebo cream twice daily for 48 weeks.
|
|---|---|---|
|
Response With >75% Adherence
LCR
|
3 participants
|
0 participants
|
|
Response With >75% Adherence
PCR
|
2 participants
|
5 participants
|
|
Response With >75% Adherence
CR
|
5 participants
|
1 participants
|
|
Response With >75% Adherence
NR
|
7 participants
|
9 participants
|
Adverse Events
AIJP
Placebo
Serious adverse events
| Measure |
AIJP
n=35 participants at risk
AIJP (Arnebia Indigo Jade Pearl): Participants administer 1/4 teaspoon of AIJP cream twice daily for 48 weeks.
|
Placebo
n=35 participants at risk
Placebo: Participants administer 1/4 teaspoon of placebo cream twice daily for 48 weeks.
|
|---|---|---|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Perianal cancer
|
0.00%
0/35 • 60 Weeks
|
2.9%
1/35 • 60 Weeks
|
Other adverse events
Adverse event data not reported
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place