Trial · NCT00189306
Open-label Study to Evaluate Clearance of Superficial Basal Cell Carcinoma After Use of Imiquimod 5% Cream
NCT00189306, Phase 3, Completed, Graceway Pharmaceuticals, LLC; results first posted 2008-11-26
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. Open-label Study to Evaluate Clearance of Superficial Basal Cell Carcinoma After Use of Imiquimod 5% Cream. Trials, record NCT00189306. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT00189306
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Open-label Study to Evaluate Clearance of Superficial Basal Cell Carcinoma After Use of Imiquimod 5% Cream
- NCT number
- NCT00189306
- Status
- Completed
- Phases
- Phase 3
- Enrollment
- 169 participants, actual
- Lead sponsor
- Graceway Pharmaceuticals, LLC
- Conditions
- Superficial Basal Cell Carcinoma
- Interventions
- Imiquimod 5% cream
- First posted
- 2005-09-19
- Last updated
- 2010-08-10
- Results first posted
- 2008-11-26
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 Sustained Clearance Rate of Superficial Basal Cell Carcinoma (sBCC) | 5 years | Number of participants clinically clear of superficial basal cell carcinoma at the treated target tumor site at the 12-week posttreatment visit (ie, initial clearance rate) who remain clear during a 5 year follow-up period. |
| Secondary | Number of Participants Cleared of Superficial Basal Cell Carcinoma at 12 Weeks | 12 week posttreatment visit | Number of participants cleared at 12 weeks(the number of subjects with no clinical evidence of superficial basal cell carcinoma at the target tumor site at the 12-week posttreatment visit) |
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 Sustained Clearance Rate of Superficial Basal Cell Carcinoma (sBCC) | 5 years | 2 data sets: ITT - all enrolled subjects and PP - ITT subjects free from major protocol violations and applied at least 60% of doses required | participants | NUMBER |
| SECONDARY | Number of Participants Cleared of Superficial Basal Cell Carcinoma at 12 Weeks | 12 week posttreatment visit | Two data sets were analyzed: intent-to-treat (ITT), consisting of all enrolled subjects and per-protocol (PP), consisting of ITT subjects who were free from major protocol violations, and who applied at least 60% of the doses required by the dosing regimen. | participants | NUMBER |
Source ClinicalTrials.gov
Results by group2
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 Sustained Clearance Rate of Superficial Basal Cell Carcinoma (sBCC) | Aldara | 119 | participants | ||
| Number of Participants Cleared of Superficial Basal Cell Carcinoma at 12 Weeks | Aldara | 159 | participants |
Source ClinicalTrials.gov
Participant flow9
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Treatment Period | STARTED | Aldara | 169 | |
| Treatment Period | COMPLETED | Aldara | 164 | |
| Treatment Period | NOT COMPLETED | Aldara | 5 | |
| Posttreatment Period | STARTED | Aldara | 169 | |
| Posttreatment Period | COMPLETED | Aldara | 157 | |
| Posttreatment Period | NOT COMPLETED | Aldara | 12 | |
| Long-Term Follow-up | STARTED | Aldara | 157 | |
| Long-Term Follow-up | COMPLETED | Aldara | 119 | |
| Long-Term Follow-up | NOT COMPLETED | Aldara | 38 |
Source ClinicalTrials.gov
Adverse events31
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 reaction | Skin and subcutaneous tissue disorders | Aldara | 100 | 169 | 100 |
| other | Headache | Nervous system disorders | Aldara | 23 | 169 | 23 |
| other | Pain | General disorders | Aldara | 9 | 169 | 9 |
| other | Rhinitis | Respiratory, thoracic and mediastinal disorders | Aldara | 8 | 169 | 8 |
| serious | Embolism pulmonary | Vascular disorders | Aldara | 1 | 169 | 1 |
| serious | Non-hodgkins lymphoma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | Aldara | 2 | 169 | 2 |
| serious | Excision BCC R forehead | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | Aldara | 1 | 169 | 1 |
| serious | Pulmonary carcinoma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | Aldara | 2 | 169 | 2 |
| serious | Bleeding post colonoscopy | Surgical and medical procedures | Aldara | 1 | 169 | 1 |
| serious | Transient ischaemic attack | Vascular disorders | Aldara | 1 | 169 | 1 |
1 to 10 of 31Source ClinicalTrials.gov
See all 31 adverse eventsAdverse event totals3
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Aldara | ||
| Total, other adverse events | Aldara | 130 | 169 |
| Total, serious adverse events | Aldara | 23 | 169 |
Source ClinicalTrials.gov
Papers2
The papers the trial lists on ClinicalTrials.gov.
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.
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/NCT00189306
GET https://conductscience.org/api/trials/v1/NCT00189306/events?page=2