Trial · NCT00116649
Open-Label Safety Study to Evaluate Imiquimod Cream, 5% for Large Areas of Actinic Keratosis
NCT00116649, Phase 4, Completed, Graceway Pharmaceuticals, LLC; results first posted 2008-11-25
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. Open-Label Safety Study to Evaluate Imiquimod Cream, 5% for Large Areas of Actinic Keratosis. Trials, record NCT00116649. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT00116649
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Open-Label Safety Study to Evaluate Imiquimod Cream, 5% for Large Areas of Actinic Keratosis
- NCT number
- NCT00116649
- Status
- Completed
- Phases
- Phase 4
- Enrollment
- 551 participants, actual
- Lead sponsor
- Graceway Pharmaceuticals, LLC
- Conditions
- Keratosis
- Interventions
- imiquimod cream
- First posted
- 2005-07-01
- Last updated
- 2010-07-20
- Results first posted
- 2008-11-25
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 Who Experienced an Adverse Event | from first dose up to 18 months | Adverse events that occurred between the first day of exposure to the study cream and study discharge were summarized. Adverse events - any untoward medical occurrence in a subject that is temporally related to protocol procedures, including the administration of a pharmaceutical product at any dose, but which does not necessarily have a causal relationship with the treatment. |
| Secondary | Percent Reduction From Baseline to the Final Follow-up in Total Actinic Keratosis Lesion Count | At Month 18 | Percent reduction = (total baseline AK lesion count - total final lesion count)x100/ total baseline AK lesion count |
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 Who Experienced an Adverse Event | from first dose up to 18 months | There were 551 subjects in the Safety population, which consisted of the enrolled subjects who received at least one dose of study medication. | participants | NUMBER |
| SECONDARY | Percent Reduction From Baseline to the Final Follow-up in Total Actinic Keratosis Lesion Count | At Month 18 | The ITT population (n=526) consisted of the Safety population who had at least one scheduled primary efficacy assessment at a post-baseline visit | percent reduction | MEAN |
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 Who Experienced an Adverse Event | Aldara (Imiquimod) Cream | 472 | participants | ||
| Percent Reduction From Baseline to the Final Follow-up in Total Actinic Keratosis Lesion Count | Aldara (Imiquimod) Cream | 80.2 | Standard Deviation 1.55 | percent reduction |
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 | Aldara (Imiquimod) Cream | 551 | |
| Overall Study | COMPLETED | Aldara (Imiquimod) Cream | 396 | |
| Overall Study | NOT COMPLETED | Aldara (Imiquimod) Cream | 155 |
Source ClinicalTrials.gov
Adverse events48
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 | Actinic Keratosis | Skin and subcutaneous tissue disorders | Aldara (Imiquimod) Cream | 168 | 551 | 168 |
| other | Application site pruritus | Skin and subcutaneous tissue disorders | Aldara (Imiquimod) Cream | 127 | 551 | 127 |
| other | Squamous cell carcinoma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | Aldara (Imiquimod) Cream | 83 | 551 | 83 |
| other | Basal cell carcinoma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | Aldara (Imiquimod) Cream | 82 | 551 | 82 |
| other | Skin lesion | Skin and subcutaneous tissue disorders | Aldara (Imiquimod) Cream | 59 | 551 | 59 |
| other | Application site irritation | General disorders | Aldara (Imiquimod) Cream | 48 | 551 | 48 |
| other | Seborrhoeic Keratosis | Skin and subcutaneous tissue disorders | Aldara (Imiquimod) Cream | 42 | 551 | 42 |
| other | Fatigue | General disorders | Aldara (Imiquimod) Cream | 34 | 551 | 34 |
| other | Skin Papilloma | Skin and subcutaneous tissue disorders | Aldara (Imiquimod) Cream | 33 | 551 | 33 |
| other | Application site pain | General disorders | Aldara (Imiquimod) Cream | 30 | 551 | 30 |
1 to 10 of 48Source ClinicalTrials.gov
See all 48 adverse eventsAdverse event totals3
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Aldara (Imiquimod) Cream | ||
| Total, other adverse events | Aldara (Imiquimod) Cream | 472 | 551 |
| Total, serious adverse events | Aldara (Imiquimod) Cream | 39 | 551 |
Source ClinicalTrials.gov
Papers1
The papers the trial lists on ClinicalTrials.gov.
| PMID | Listed as |
|---|---|
| 20729935 | RESULT |
Source PubMed
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/NCT00116649
GET https://conductscience.org/api/trials/v1/NCT00116649/events?page=2