Trial · NCT00603798
Safety and Effectiveness Study of Imiquimod Creams for the Treatment of Actinic Keratoses (AKs)
NCT00603798, Phase 3, Completed, Graceway Pharmaceuticals, LLC; results first posted 2010-06-22
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. Safety and Effectiveness Study of Imiquimod Creams for the Treatment of Actinic Keratoses (AKs). Trials, record NCT00603798. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT00603798
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Safety and Effectiveness Study of Imiquimod Creams for the Treatment of Actinic Keratoses (AKs)
- NCT number
- NCT00603798
- Status
- Completed
- Phases
- Phase 3
- Enrollment
- 490 participants, actual
- Lead sponsor
- Graceway Pharmaceuticals, LLC
- Conditions
- Actinic Keratosis
- Interventions
- Imiquimod cream, Placebo cream, Imiquimod cream
- First posted
- 2008-01-29
- Last updated
- 2010-06-29
- Results first posted
- 2010-06-22
Source ClinicalTrials.gov
Registered outcomes4
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Number of Participants With Complete Clearance of AK Lesions | End of Study the Week 17 visit | Subject status with respect to complete clearance of AK lesions at End of Study (EOS), ie, the Week 17 visit. Complete clearance was defined as the absence of clinically visible or palpable AK lesions in the treatment area. All lesions within the identified treatment area were included in the count, even if the lesion was a new lesion or "subclinical" lesion that had not been identified at Baseline. |
| Secondary | Number of Participants With Partial Clearance of AK Lesions | End of Study the Week 17 visit | Subject status with respect to complete clearance of AK lesions at End of Study (EOS), defined as at least a 75% reduction in the number of AK lesions in the treatment area compared with Baseline. |
| Secondary | Percent Change From Baseline in AK Lesion Count | At all visits - Baseline through the Week 17 EOS visit | Percent change from Baseline to end of study (EOS) in investigator counts of AK lesions. A negative percent change is better than a positive percent change. |
| Secondary | Local Skin Reactions (LSR) | The time period for the AUC extends to 8 weeks after the end of treatment (Week 17) | Six local skin reaction (LSR) signs were predefined and were assessed for presence and intensity at each visit. These included: Erythema, edema, Weeping/Exudate, Flaking/Scaling/Dryness, Scabbing/Crusting and Erosion/Ulceration. The LSRs were scored as 0=none, 1=mild, 2=moderate, 3=severe. Summary of LSR - area under the curve (AUC) of sum of LSR scores (days). |
Source ClinicalTrials.gov
Outcomes4
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 Clearance of AK Lesions | End of Study the Week 17 visit | Efficacy analyses were conducted on the intent-to-treat (ITT) population. For the primary efficacy variable, imputations were made for missing data points using last observation carried forward (LOCF), primary analysis), taking all missed observations as failure (sensitivity analysis), and using observed cases only (supportive analysis). | participants | NUMBER |
| SECONDARY | Number of Participants With Partial Clearance of AK Lesions | End of Study the Week 17 visit | Efficacy analyses were conducted on the intent-to-treat (ITT) population. Imputations were made for missing data points using last observation carried forward (LOCF). | participants | NUMBER |
| SECONDARY | Percent Change From Baseline in AK Lesion Count | At all visits - Baseline through the Week 17 EOS visit | Intent to treat (ITT) population using last observation carried forward (LOCF). | percentage of participants | MEDIAN |
| SECONDARY | Local Skin Reactions (LSR) | The time period for the AUC extends to 8 weeks after the end of treatment (Week 17) | All participants were evaluated for local skin reactions (LSR) at every visit. The ITT population was used. Only subjects who received treatment in both cycles are included in the analysis. | units on a scale * days | MEAN |
Source ClinicalTrials.gov
Results by group12
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 Complete Clearance of AK Lesions | 3.75% Imiquimod Cream | 55 | participants | ||
| Number of Participants With Complete Clearance of AK Lesions | 2.5% Imiquimod Cream | 41 | participants | ||
| Number of Participants With Complete Clearance of AK Lesions | Placebo Cream | 9 | participants | ||
| Number of Participants With Partial Clearance of AK Lesions | 3.75% Imiquimod Cream | 87 | participants | ||
| Number of Participants With Partial Clearance of AK Lesions | 2.5% Imiquimod Cream | 70 | participants | ||
| Number of Participants With Partial Clearance of AK Lesions | Placebo Cream | 21 | participants | ||
| Percent Change From Baseline in AK Lesion Count | 3.75% Imiquimod Cream | -80.0 | Full Range -100.0 to 160.0 | percentage of participants | |
| Percent Change From Baseline in AK Lesion Count | 2.5% Imiquimod Cream | -66.7 | Full Range -100.0 to 183.3 | percentage of participants | |
| Percent Change From Baseline in AK Lesion Count | Placebo Cream | -23.6 | Full Range -100.0 to 200.0 | percentage of participants | |
| Local Skin Reactions (LSR) | 3.75% Imiquimod Cream | 413.5 | Standard Deviation 187.7 | units on a scale * days |
1 to 10 of 12Source ClinicalTrials.gov
See all 12 results by groupParticipant flow9
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | 3.75% Imiquimod Cream | 162 | |
| Overall Study | STARTED | 2.5% Imiquimod Cream | 164 | |
| Overall Study | STARTED | Placebo Cream | 164 | |
| Overall Study | COMPLETED | 3.75% Imiquimod Cream | 152 | |
| Overall Study | COMPLETED | 2.5% Imiquimod Cream | 157 | |
| Overall Study | COMPLETED | Placebo Cream | 154 | |
| Overall Study | NOT COMPLETED | 3.75% Imiquimod Cream | 10 | |
| Overall Study | NOT COMPLETED | 2.5% Imiquimod Cream | 7 | |
| Overall Study | NOT COMPLETED | Placebo Cream | 10 |
Source ClinicalTrials.gov
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 pruritus | General disorders | 3.75% Imiquimod Cream | 15 | 162 | 15 |
| other | Application site pruritus | General disorders | 2.5% Imiquimod Cream | 12 | 164 | 12 |
| other | Application site pruritus | General disorders | Placebo Cream | 1 | 164 | 1 |
| other | Application site irritation | General disorders | 3.75% Imiquimod Cream | 9 | 162 | 9 |
| other | Application site irritation | General disorders | 2.5% Imiquimod Cream | 6 | 164 | 6 |
| other | Application site irritation | General disorders | Placebo Cream | 1 | 164 | 1 |
| other | Application site pain | General disorders | 3.75% Imiquimod Cream | 15 | 162 | 15 |
| other | Application site pain | General disorders | 2.5% Imiquimod Cream | 11 | 164 | 11 |
| other | Application site pain | General disorders | Placebo Cream | 0 | 164 | 0 |
| serious | Breast cancer | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | 3.75% Imiquimod Cream | 1 | 162 | 1 |
1 to 10 of 60Source ClinicalTrials.gov
See all 60 adverse eventsAdverse event totals9
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | 3.75% Imiquimod Cream | ||
| Total, all-cause mortality | 2.5% Imiquimod Cream | ||
| Total, all-cause mortality | Placebo Cream | ||
| Total, other adverse events | 3.75% Imiquimod Cream | 39 | 162 |
| Total, other adverse events | 2.5% Imiquimod Cream | 29 | 164 |
| Total, other adverse events | Placebo Cream | 2 | 164 |
| Total, serious adverse events | 3.75% Imiquimod Cream | 10 | 162 |
| Total, serious adverse events | 2.5% Imiquimod Cream | 5 | 164 |
| Total, serious adverse events | Placebo Cream | 3 | 164 |
Source ClinicalTrials.gov
Papers1
The papers the trial lists on ClinicalTrials.gov.
| PMID | Listed as |
|---|---|
| 20133012 | BACKGROUND |
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/NCT00603798
GET https://conductscience.org/api/trials/v1/NCT00603798/events?page=2