Trial Outcomes & Findings for An Open-Label Safety Study of API 31510 in a Topical Cream for in Situ Cutaneous Squamous Cell Carcinoma (SCCIS) (NCT NCT00652080)
NCT ID: NCT00652080
Last Updated: 2019-03-05
Results Overview
To determine the safety and tolerability of API 31510 cream 3%, topically applied to in situ cutaneous squamous cell carcinomas (SCCIS).
Recruitment status
COMPLETED
Study phase
PHASE1/PHASE2
Target enrollment
35 participants
Primary outcome timeframe
6 weeks
Results posted on
2019-03-05
Participant Flow
Subjects were required to have at least one histologically-confirmed SCCIS lesion that was suitable for excision, ie, to have a lesion with a minimum area of 0.5 cm2 and a maximum diameter of 2.0 cm.
Participant milestones
| Measure |
API 31510 Topical Cream
Active Cream 3%; AM \& PM
API 31510: Topical Cream; 3% active; AM \& PM application
|
|---|---|
|
Overall Study
STARTED
|
35
|
|
Overall Study
COMPLETED
|
31
|
|
Overall Study
NOT COMPLETED
|
4
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
An Open-Label Safety Study of API 31510 in a Topical Cream for in Situ Cutaneous Squamous Cell Carcinoma (SCCIS)
Baseline characteristics by cohort
| Measure |
API 31510 Topical Cream
n=35 Participants
Active Cream 3%; AM \& PM
API 31510: Topical Cream; 3% active; AM \& PM application
|
|---|---|
|
Age, Continuous
|
67.6 years
STANDARD_DEVIATION 10.3 • n=5 Participants
|
|
Sex: Female, Male
Female
|
24 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
11 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
1 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
34 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Black or African American
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
35 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: 6 weeksPopulation: Safety Population: All subjects who took at least one dose of the investigational product.
To determine the safety and tolerability of API 31510 cream 3%, topically applied to in situ cutaneous squamous cell carcinomas (SCCIS).
Outcome measures
| Measure |
Safety Population
n=35 Participants
Active Cream 3%; AM \& PM
API 31510: Topical Cream; 3% active; AM \& PM application
|
PP Population
Active Cream 3%; AM \& PM
API 31510: Topical Cream; 3% active; AM \& PM application
|
|---|---|---|
|
Number of Participants With Adverse Events
Subjects with an AE (Mild)
|
10 Participants
|
—
|
|
Number of Participants With Adverse Events
Subjects with an AE (Moderate)
|
4 Participants
|
—
|
|
Number of Participants With Adverse Events
Subjects with an AE (Severe)
|
1 Participants
|
—
|
|
Number of Participants With Adverse Events
Subjects without an AE
|
20 Participants
|
—
|
SECONDARY outcome
Timeframe: 6 weeksPopulation: Intent-to-Treat (ITT) Population: All subjects who were dispensed the study drug were included in this population. Per Protocol (PP) Population: All subjects who had SCCIS confirmed via histological results at baseline, had a Week 6 histological examination, and did not miss any interim visits.
To obtain a preliminary determination of the efficacy of API 31510 cream 3%,topically applied to in situ cutaneous squamous cell carcinomas. The subject was considered to have had a complete response only if the histological examination of the target lesion was negative.
Outcome measures
| Measure |
Safety Population
n=34 Participants
Active Cream 3%; AM \& PM
API 31510: Topical Cream; 3% active; AM \& PM application
|
PP Population
n=27 Participants
Active Cream 3%; AM \& PM
API 31510: Topical Cream; 3% active; AM \& PM application
|
|---|---|---|
|
Percentage of Participants With a Complete Response
|
8 Participants
|
5 Participants
|
Adverse Events
1 Safety Population
Serious events: 1 serious events
Other events: 22 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
1 Safety Population
n=35 participants at risk
Active Cream 3%; AM \& PM
API 31510: Topical Cream; 3% active; AM \& PM application
|
|---|---|
|
Gastrointestinal disorders
Pancreatitis
|
2.9%
1/35 • Number of events 1 • All subjects in this study were treated with a formulation of CoQ10 3% topical cream that was applied twice daily for 6 weeks. The mean duration (SD) of treatment was 41.4 days (6.7) and ranged from 21 to 47 days.
|
Other adverse events
| Measure |
1 Safety Population
n=35 participants at risk
Active Cream 3%; AM \& PM
API 31510: Topical Cream; 3% active; AM \& PM application
|
|---|---|
|
Skin and subcutaneous tissue disorders
Application site erythema
|
20.0%
7/35 • Number of events 7 • All subjects in this study were treated with a formulation of CoQ10 3% topical cream that was applied twice daily for 6 weeks. The mean duration (SD) of treatment was 41.4 days (6.7) and ranged from 21 to 47 days.
|
|
Vascular disorders
Hypertension
|
2.9%
1/35 • Number of events 1 • All subjects in this study were treated with a formulation of CoQ10 3% topical cream that was applied twice daily for 6 weeks. The mean duration (SD) of treatment was 41.4 days (6.7) and ranged from 21 to 47 days.
|
|
Skin and subcutaneous tissue disorders
Application site dryness
|
2.9%
1/35 • Number of events 1 • All subjects in this study were treated with a formulation of CoQ10 3% topical cream that was applied twice daily for 6 weeks. The mean duration (SD) of treatment was 41.4 days (6.7) and ranged from 21 to 47 days.
|
|
Skin and subcutaneous tissue disorders
Application site exfoliation
|
2.9%
1/35 • Number of events 1 • All subjects in this study were treated with a formulation of CoQ10 3% topical cream that was applied twice daily for 6 weeks. The mean duration (SD) of treatment was 41.4 days (6.7) and ranged from 21 to 47 days.
|
|
Skin and subcutaneous tissue disorders
Pruritus
|
2.9%
1/35 • Number of events 1 • All subjects in this study were treated with a formulation of CoQ10 3% topical cream that was applied twice daily for 6 weeks. The mean duration (SD) of treatment was 41.4 days (6.7) and ranged from 21 to 47 days.
|
|
Infections and infestations
Cellulitis
|
2.9%
1/35 • Number of events 1 • All subjects in this study were treated with a formulation of CoQ10 3% topical cream that was applied twice daily for 6 weeks. The mean duration (SD) of treatment was 41.4 days (6.7) and ranged from 21 to 47 days.
|
|
Infections and infestations
Folliculitis
|
2.9%
1/35 • Number of events 1 • All subjects in this study were treated with a formulation of CoQ10 3% topical cream that was applied twice daily for 6 weeks. The mean duration (SD) of treatment was 41.4 days (6.7) and ranged from 21 to 47 days.
|
|
Infections and infestations
Gastrointestinal infection
|
2.9%
1/35 • Number of events 1 • All subjects in this study were treated with a formulation of CoQ10 3% topical cream that was applied twice daily for 6 weeks. The mean duration (SD) of treatment was 41.4 days (6.7) and ranged from 21 to 47 days.
|
|
Infections and infestations
Sinusitis
|
2.9%
1/35 • Number of events 1 • All subjects in this study were treated with a formulation of CoQ10 3% topical cream that was applied twice daily for 6 weeks. The mean duration (SD) of treatment was 41.4 days (6.7) and ranged from 21 to 47 days.
|
|
Gastrointestinal disorders
Diarrhea
|
2.9%
1/35 • Number of events 1 • All subjects in this study were treated with a formulation of CoQ10 3% topical cream that was applied twice daily for 6 weeks. The mean duration (SD) of treatment was 41.4 days (6.7) and ranged from 21 to 47 days.
|
|
Gastrointestinal disorders
Pancreatitis
|
2.9%
1/35 • Number of events 1 • All subjects in this study were treated with a formulation of CoQ10 3% topical cream that was applied twice daily for 6 weeks. The mean duration (SD) of treatment was 41.4 days (6.7) and ranged from 21 to 47 days.
|
|
Nervous system disorders
Burning sensation
|
2.9%
1/35 • Number of events 1 • All subjects in this study were treated with a formulation of CoQ10 3% topical cream that was applied twice daily for 6 weeks. The mean duration (SD) of treatment was 41.4 days (6.7) and ranged from 21 to 47 days.
|
|
Nervous system disorders
Headache
|
2.9%
1/35 • Number of events 1 • All subjects in this study were treated with a formulation of CoQ10 3% topical cream that was applied twice daily for 6 weeks. The mean duration (SD) of treatment was 41.4 days (6.7) and ranged from 21 to 47 days.
|
|
General disorders
Application site bleeding
|
2.9%
1/35 • Number of events 1 • All subjects in this study were treated with a formulation of CoQ10 3% topical cream that was applied twice daily for 6 weeks. The mean duration (SD) of treatment was 41.4 days (6.7) and ranged from 21 to 47 days.
|
|
Injury, poisoning and procedural complications
Excoriation
|
2.9%
1/35 • Number of events 1 • All subjects in this study were treated with a formulation of CoQ10 3% topical cream that was applied twice daily for 6 weeks. The mean duration (SD) of treatment was 41.4 days (6.7) and ranged from 21 to 47 days.
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
2.9%
1/35 • Number of events 1 • All subjects in this study were treated with a formulation of CoQ10 3% topical cream that was applied twice daily for 6 weeks. The mean duration (SD) of treatment was 41.4 days (6.7) and ranged from 21 to 47 days.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place