Trial · NCT00604890

Dose-Ranging Clinical Trial of Topical Creams Containing API 31510 for the Treatment of Superficial Basal Cell Carcinoma

NCT00604890, Phase 1, Phase 2, Completed, BPGbio; results first posted 2019-03-05

3 sourcestrials-2026-11-12-0.5.0

Cite this record

ConductScience Library. Dose-Ranging Clinical Trial of Topical Creams Containing API 31510 for the Treatment of Superficial Basal Cell Carcinoma. Trials, record NCT00604890. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT00604890

On this page

Trial

As registered on ClinicalTrials.gov, in the graph's capture of the registry.

Title: Dose-Ranging Clinical Trial of Topical Creams Containing API 31510 for the Treatment of Superficial Basal Cell Carcinoma
NCT number: NCT00604890
Status: Completed
Phases: Phase 1, Phase 2
Enrollment: 186 participants, actual
Lead sponsor: BPGbio
Conditions: Superficial Basal Cell Carcinoma
Interventions: API 31510 3% Topical Cream, API 31510 1.5% Topical Cream, Placebo
First posted: 2008-01-30
Last updated: 2025-02-28
Results first posted: 2019-03-05

Source ClinicalTrials.gov

Registered outcomes2

Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.

List	Outcome	Time frame	Description
Primary	Number of Participants With Complete Response	10 weeks	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).
Secondary	Number of Participants With Partial Response	10 weeks	To 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)

Source ClinicalTrials.gov

Outcomes2

Each outcome the trial posted results for, in ClinicalTrials.gov's words.

Type	Outcome	Time frame	Population	Units	Measured as
PRIMARY	Number of Participants With Complete Response	10 weeks		Participants	COUNT_OF_PARTICIPANTS
SECONDARY	Number of Participants With Partial Response	10 weeks		Participants	COUNT_OF_PARTICIPANTS

Source ClinicalTrials.gov

Results by group8

Each measurement the trial posted, group by group, in the words and numbers it posted.

Outcome	Group	Value	Units
Number of Participants With Complete Response	3% Active Cream BID	9	Participants
Number of Participants With Complete Response	3% Active Cream QD	5	Participants
Number of Participants With Complete Response	1.5% QD	7	Participants
Number of Participants With Complete Response	Placebo BID	9	Participants
Number of Participants With Partial Response	3% Active Cream BID	11	Participants
Number of Participants With Partial Response	3% QD	8	Participants
Number of Participants With Partial Response	1.5% QD	13	Participants
Number of Participants With Partial Response	Placebo BID	13	Participants

Source ClinicalTrials.gov

Participant flow12

How many started, completed or left each group, period by period.

Period	Milestone	Group	Participants
Overall Study	STARTED	3% Active Cream BID(Twice Daily)	47
Overall Study	STARTED	3% Active Cream QD(Once Daily)	45
Overall Study	STARTED	1.5% Active Cream QD(Once Daily)	48
Overall Study	STARTED	Placebo BID(Twice Daily)	46
Overall Study	COMPLETED	3% Active Cream BID(Twice Daily)	44
Overall Study	COMPLETED	3% Active Cream QD(Once Daily)	45
Overall Study	COMPLETED	1.5% Active Cream QD(Once Daily)	47
Overall Study	COMPLETED	Placebo BID(Twice Daily)	42
Overall Study	NOT COMPLETED	3% Active Cream BID(Twice Daily)	3
Overall Study	NOT COMPLETED	3% Active Cream QD(Once Daily)	0

1 to 10 of 12Source ClinicalTrials.gov

See all 12 participant flow

Adverse events60

Each adverse event the trial posted, group by group: the participants affected out of those at risk.

Type	Event	Organ system	Group	Affected	At risk	Events
other	Application Site Etythema	Skin and subcutaneous tissue disorders	3% Active Cream BID	8	47	8
other	Application Site Etythema	Skin and subcutaneous tissue disorders	3% QD	10	45	10
other	Application Site Etythema	Skin and subcutaneous tissue disorders	1.5% QD	8	48	8
other	Application Site Etythema	Skin and subcutaneous tissue disorders	Placebo BID	7	46	7
other	Application Site Dryness	Skin and subcutaneous tissue disorders	3% Active Cream BID	2	47	2
other	Application Site Dryness	Skin and subcutaneous tissue disorders	3% QD	2	45	2
other	Application Site Dryness	Skin and subcutaneous tissue disorders	1.5% QD	2	48	2
other	Application Site Dryness	Skin and subcutaneous tissue disorders	Placebo BID	2	46	2
other	Rash	Skin and subcutaneous tissue disorders	3% Active Cream BID	1	47	1
other	Rash	Skin and subcutaneous tissue disorders	3% QD	1	45	1

1 to 10 of 60Source ClinicalTrials.gov

See all 60 adverse events

Adverse event totals12

The totals the trial posted for each group.

Total	Group	Affected	At risk
Total, all-cause mortality	3% Active Cream BID
Total, all-cause mortality	3% QD
Total, all-cause mortality	1.5% QD
Total, all-cause mortality	Placebo BID
Total, other adverse events	3% Active Cream BID	14	47
Total, other adverse events	3% QD	22	45
Total, other adverse events	1.5% QD	18	48
Total, other adverse events	Placebo BID	26	46
Total, serious adverse events	3% Active Cream BID	3	47
Total, serious adverse events	3% QD	0	45

1 to 10 of 12Source ClinicalTrials.gov

See all 12 adverse event totals

Papers0

The papers the trial lists on ClinicalTrials.gov.

None in this release.

Grants0

The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.

None in this release.

Trial comparisons0

Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.

None in this release.

Tests0

The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.

None in this release.

Data dates

The day each source was copied for this release.

ClinicalTrials.gov: 2026-11-12; ClinicalTrials.gov
Results, from AACT: 2026-03-23; AACT
NIH grant links: 2026-11-13; NIH RePORTER

Sources 3

ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
ClinicalTrials.govNo license stated
NIH RePORTER's clinical studies and project filesPublic domain

Each source's terms

ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
ClinicalTrials.govnone stated
NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)

ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.

For software

Read this trial from software.

The record and each of its lists are JSON, twenty rows a page. No key.

GET https://conductscience.org/api/trials/v1/NCT00604890

GET https://conductscience.org/api/trials/v1/NCT00604890/events?page=2

API reference For AI assistants