Trial Outcomes & Findings for Dose-Ranging Clinical Trial of Topical Creams Containing API 31510 for the Treatment of Superficial Basal Cell Carcinoma (NCT NCT00604890)
NCT ID: NCT00604890
Last Updated: 2025-02-28
Results Overview
To determine the number of participants with a complete response, defined as a negative histological examination of the sBCC lesion at Week 10 (4 weeks post-treatment).
Recruitment status
COMPLETED
Study phase
PHASE1/PHASE2
Target enrollment
186 participants
Primary outcome timeframe
10 weeks
Results posted on
2025-02-28
Participant Flow
Participant milestones
| Measure |
3% Active Cream BID(Twice Daily)
Topical Treatment 3.0% active cream applied to the lesion twice daily (BID)
|
3% Active Cream QD(Once Daily)
Topical treatment 3.0% active cream applied to the lesion once daily (PM) plus placebo cream applied to the lesion once daily (AM)
|
1.5% Active Cream QD(Once Daily)
Topical treatment 1.5% active cream applied to the lesion once daily (PM) plus placebo cream applied to the lesion once daily (AM)
|
Placebo BID(Twice Daily)
Placebo cream applied to the lesion twice daily
|
|---|---|---|---|---|
|
Overall Study
STARTED
|
47
|
45
|
48
|
46
|
|
Overall Study
COMPLETED
|
44
|
45
|
47
|
42
|
|
Overall Study
NOT COMPLETED
|
3
|
0
|
1
|
4
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Dose-Ranging Clinical Trial of Topical Creams Containing API 31510 for the Treatment of Superficial Basal Cell Carcinoma
Baseline characteristics by cohort
| Measure |
3% BID
n=47 Participants
3.0% active twice daily (BID)
|
3% QD
n=45 Participants
3.0% active cream once daily (QD) plus placebo cream QD
|
1.5% QD
n=48 Participants
1.5% active cream once daily (QD) plus placebo cream QD
|
Placebo
n=46 Participants
Placebo cream twice daily (BID)
|
Total
n=186 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|
|
Age, Continuous
|
62.6 years
n=5 Participants
|
61.2 years
n=7 Participants
|
60.4 years
n=5 Participants
|
62.8 years
n=4 Participants
|
61.7 years
n=21 Participants
|
|
Sex: Female, Male
Female
|
17 Participants
n=5 Participants
|
20 Participants
n=7 Participants
|
23 Participants
n=5 Participants
|
16 Participants
n=4 Participants
|
76 Participants
n=21 Participants
|
|
Sex: Female, Male
Male
|
30 Participants
n=5 Participants
|
25 Participants
n=7 Participants
|
25 Participants
n=5 Participants
|
30 Participants
n=4 Participants
|
110 Participants
n=21 Participants
|
PRIMARY outcome
Timeframe: 10 weeksTo determine the number of participants with a complete response, defined as a negative histological examination of the sBCC lesion at Week 10 (4 weeks post-treatment).
Outcome measures
| Measure |
3% Active Cream BID
n=44 Participants
3.0% active cream twice daily (BID)
|
3% Active Cream QD
n=45 Participants
3.0% active cream once daily (QD) plus placebo cream QD
|
1.5% QD
n=47 Participants
1.5% active cream once daily (QD) plus placebo cream QD
|
Placebo BID
n=45 Participants
Placebo cream twice daily (BID)
|
|---|---|---|---|---|
|
Number of Participants With Complete Response
|
9 Participants
|
5 Participants
|
7 Participants
|
9 Participants
|
SECONDARY outcome
Timeframe: 10 weeksTo determine the number of participants with a partial response, defined as a clinically significant decrease (ie, at least 50%) in the area of the sBCC lesion, computed as the product of the two principal diameters at Week 10 (4 weeks post-treatment)
Outcome measures
| Measure |
3% Active Cream BID
n=46 Participants
3.0% active cream twice daily (BID)
|
3% Active Cream QD
n=45 Participants
3.0% active cream once daily (QD) plus placebo cream QD
|
1.5% QD
n=48 Participants
1.5% active cream once daily (QD) plus placebo cream QD
|
Placebo BID
n=45 Participants
Placebo cream twice daily (BID)
|
|---|---|---|---|---|
|
Number of Participants With Partial Response
|
11 Participants
|
8 Participants
|
13 Participants
|
13 Participants
|
Adverse Events
3% Active Cream BID
Serious events: 3 serious events
Other events: 14 other events
Deaths: 0 deaths
3% QD
Serious events: 0 serious events
Other events: 22 other events
Deaths: 0 deaths
1.5% QD
Serious events: 0 serious events
Other events: 18 other events
Deaths: 0 deaths
Placebo BID
Serious events: 0 serious events
Other events: 26 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
3% Active Cream BID
n=47 participants at risk
3.0% active cream twice daily (BID)
|
3% QD
n=45 participants at risk
3.0% active cream once daily QD plus placebo cream QD
|
1.5% QD
n=48 participants at risk
1.5% active cream once daily (QD) plus placebo cream QD
|
Placebo BID
n=46 participants at risk
Placebo cream twice daily (BID)
|
|---|---|---|---|---|
|
Cardiac disorders
Blockage ( L ) Anterior Artery/Percutaneous Coronary Intervention (Stent) # 6 = Primary Care
|
2.1%
1/47 • Number of events 1
|
0.00%
0/45
|
0.00%
0/48
|
0.00%
0/46
|
|
Infections and infestations
Sepsis
|
2.1%
1/47 • Number of events 1
|
0.00%
0/45
|
0.00%
0/48
|
0.00%
0/46
|
|
Cardiac disorders
Sudden Death
|
2.1%
1/47 • Number of events 1
|
0.00%
0/45
|
0.00%
0/48
|
0.00%
0/46
|
Other adverse events
| Measure |
3% Active Cream BID
n=47 participants at risk
3.0% active cream twice daily (BID)
|
3% QD
n=45 participants at risk
3.0% active cream once daily QD plus placebo cream QD
|
1.5% QD
n=48 participants at risk
1.5% active cream once daily (QD) plus placebo cream QD
|
Placebo BID
n=46 participants at risk
Placebo cream twice daily (BID)
|
|---|---|---|---|---|
|
Skin and subcutaneous tissue disorders
Application Site Etythema
|
17.0%
8/47 • Number of events 8
|
22.2%
10/45 • Number of events 10
|
16.7%
8/48 • Number of events 8
|
15.2%
7/46 • Number of events 7
|
|
Skin and subcutaneous tissue disorders
Application Site Dryness
|
4.3%
2/47 • Number of events 2
|
4.4%
2/45 • Number of events 2
|
4.2%
2/48 • Number of events 2
|
4.3%
2/46 • Number of events 2
|
|
Skin and subcutaneous tissue disorders
Rash
|
2.1%
1/47 • Number of events 1
|
2.2%
1/45 • Number of events 1
|
2.1%
1/48 • Number of events 1
|
8.7%
4/46 • Number of events 4
|
|
Skin and subcutaneous tissue disorders
Application Site Exfoliation
|
0.00%
0/47
|
4.4%
2/45 • Number of events 2
|
4.2%
2/48 • Number of events 2
|
4.3%
2/46 • Number of events 2
|
|
Infections and infestations
Nasopharyngitis
|
2.1%
1/47 • Number of events 1
|
4.4%
2/45 • Number of events 2
|
4.2%
2/48 • Number of events 2
|
2.2%
1/46 • Number of events 1
|
|
Infections and infestations
Urinary tract infection
|
0.00%
0/47
|
4.4%
2/45 • Number of events 2
|
0.00%
0/48
|
6.5%
3/46 • Number of events 3
|
|
Skin and subcutaneous tissue disorders
Application site pruritus
|
0.00%
0/47
|
4.4%
2/45 • Number of events 2
|
2.1%
1/48 • Number of events 1
|
2.2%
1/46 • Number of events 1
|
|
Respiratory, thoracic and mediastinal disorders
Pharyngolaryngeal pain
|
0.00%
0/47
|
0.00%
0/45
|
4.2%
2/48 • Number of events 2
|
4.3%
2/46 • Number of events 2
|
|
General disorders
Application site bleeding
|
0.00%
0/47
|
4.4%
2/45 • Number of events 2
|
0.00%
0/48
|
2.2%
1/46 • Number of events 1
|
|
Infections and infestations
Upper respiratory tract infection
|
0.00%
0/47
|
0.00%
0/45
|
4.2%
2/48 • Number of events 2
|
2.2%
1/46 • Number of events 1
|
|
Skin and subcutaneous tissue disorders
Dry Skin
|
4.3%
2/47 • Number of events 2
|
0.00%
0/45
|
0.00%
0/48
|
0.00%
0/46
|
|
Infections and infestations
Bronchitis
|
0.00%
0/47
|
0.00%
0/45
|
0.00%
0/48
|
4.3%
2/46 • Number of events 2
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place