Trial · NCT00652080
An Open-Label Safety Study of API 31510 in a Topical Cream for in Situ Cutaneous Squamous Cell Carcinoma (SCCIS)
NCT00652080, Phase 1, Phase 2, Completed, BPGbio; results first posted 2019-02-15
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. An Open-Label Safety Study of API 31510 in a Topical Cream for in Situ Cutaneous Squamous Cell Carcinoma (SCCIS). Trials, record NCT00652080. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT00652080
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- An Open-Label Safety Study of API 31510 in a Topical Cream for in Situ Cutaneous Squamous Cell Carcinoma (SCCIS)
- NCT number
- NCT00652080
- Status
- Completed
- Phases
- Phase 1, Phase 2
- Enrollment
- 35 participants, actual
- Lead sponsor
- BPGbio
- Conditions
- Squamous Cell Carcinoma
- Interventions
- API 31510
- First posted
- 2008-04-03
- Last updated
- 2019-03-05
- Results first posted
- 2019-02-15
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 Adverse Events | 6 weeks | To determine the safety and tolerability of API 31510 cream 3%, topically applied to in situ cutaneous squamous cell carcinomas (SCCIS). |
| Secondary | Percentage of Participants With a Complete Response | 6 weeks | 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. |
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 Adverse Events | 6 weeks | Safety Population: All subjects who took at least one dose of the investigational product. | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Percentage of Participants With a Complete Response | 6 weeks | 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. | Participants | COUNT_OF_PARTICIPANTS |
Source ClinicalTrials.gov
Results by group6
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Number of Participants With Adverse Events | Safety Population | Subjects with an AE (Mild) | 10 | Participants | |
| Number of Participants With Adverse Events | Safety Population | Subjects with an AE (Moderate) | 4 | Participants | |
| Number of Participants With Adverse Events | Safety Population | Subjects with an AE (Severe) | 1 | Participants | |
| Number of Participants With Adverse Events | Safety Population | Subjects without an AE | 20 | Participants | |
| Percentage of Participants With a Complete Response | ITT Population | 8 | Participants | ||
| Percentage of Participants With a Complete Response | PP Population | 5 | Participants |
Source ClinicalTrials.gov
Participant flow3
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | API 31510 Topical Cream | 35 | |
| Overall Study | COMPLETED | API 31510 Topical Cream | 31 | |
| Overall Study | NOT COMPLETED | API 31510 Topical Cream | 4 |
Source ClinicalTrials.gov
Adverse events17
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 erythema | Skin and subcutaneous tissue disorders | 1 Safety Population | 7 | 35 | 7 |
| other | Application site dryness | Skin and subcutaneous tissue disorders | 1 Safety Population | 1 | 35 | 1 |
| other | Application site exfoliation | Skin and subcutaneous tissue disorders | 1 Safety Population | 1 | 35 | 1 |
| other | Pruritus | Skin and subcutaneous tissue disorders | 1 Safety Population | 1 | 35 | 1 |
| other | Cellulitis | Infections and infestations | 1 Safety Population | 1 | 35 | 1 |
| other | Folliculitis | Infections and infestations | 1 Safety Population | 1 | 35 | 1 |
| other | Gastrointestinal infection | Infections and infestations | 1 Safety Population | 1 | 35 | 1 |
| other | Sinusitis | Infections and infestations | 1 Safety Population | 1 | 35 | 1 |
| other | Diarrhea | Gastrointestinal disorders | 1 Safety Population | 1 | 35 | 1 |
| other | Pancreatitis | Gastrointestinal disorders | 1 Safety Population | 1 | 35 | 1 |
1 to 10 of 17Source ClinicalTrials.gov
See all 17 adverse eventsAdverse event totals3
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | 1 Safety Population | ||
| Total, other adverse events | 1 Safety Population | 22 | 35 |
| Total, serious adverse events | 1 Safety Population | 1 | 35 |
Source ClinicalTrials.gov
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 comparisons1
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
| Comparison |
|---|
| ITT Population vs PP Population: Percentage of Participants With a Complete Response |
Source Trial comparisons
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.
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/NCT00652080
GET https://conductscience.org/api/trials/v1/NCT00652080/registered