Trial · NCT01686152
Study Comparing Imiquimod Cream, 3.75% to Zyclara® (Imiquimod) Cream, 3.75% in the Treatment of Actinic Keratosis
NCT01686152, Phase 3, Completed, Teva Pharmaceuticals USA; results first posted 2020-10-30
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. Study Comparing Imiquimod Cream, 3.75% to Zyclara® (Imiquimod) Cream, 3.75% in the Treatment of Actinic Keratosis. Trials, record NCT01686152. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT01686152
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Study Comparing Imiquimod Cream, 3.75% to Zyclara® (Imiquimod) Cream, 3.75% in the Treatment of Actinic Keratosis
- NCT number
- NCT01686152
- Status
- Completed
- Phases
- Phase 3
- Enrollment
- 589 participants, actual
- Lead sponsor
- Teva Pharmaceuticals USA
- Conditions
- Actinic Keratosis
- Interventions
- Imiquimod Cream, 3.75%, Zyclara®, Vehicle of Test Product
- First posted
- 2012-09-17
- Last updated
- 2020-11-24
- Results first posted
- 2020-10-30
Source ClinicalTrials.gov
Registered outcomes1
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Number of Participants With Treatment Success/Failure at Visit 5/Week 14 | 14 Weeks | The primary efficacy endpoint is the proportion of subjects with treatment success at Visit 5/Week 14 (8 weeks post-treatment). Treatment success is defined as 100% clearance of all AK lesions (baseline AK lesions and any new AK lesions) within the treatment area. |
Source ClinicalTrials.gov
Outcomes1
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 Treatment Success/Failure at Visit 5/Week 14 | 14 Weeks | Per-Protocol Population | 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 Treatment Success/Failure at Visit 5/Week 14 | Investigational Test Product | Success (100% clearance of AK lesions) | 42 | Participants | |
| Number of Participants With Treatment Success/Failure at Visit 5/Week 14 | Reference Listed Drug | Success (100% clearance of AK lesions) | 40 | Participants | |
| Number of Participants With Treatment Success/Failure at Visit 5/Week 14 | Vehicle | Success (100% clearance of AK lesions) | 6 | Participants | |
| Number of Participants With Treatment Success/Failure at Visit 5/Week 14 | Investigational Test Product | Failure <100% clearance of AK lesions | 136 | Participants | |
| Number of Participants With Treatment Success/Failure at Visit 5/Week 14 | Reference Listed Drug | Failure <100% clearance of AK lesions | 139 | Participants | |
| Number of Participants With Treatment Success/Failure at Visit 5/Week 14 | Vehicle | Failure <100% clearance of AK lesions | 58 | Participants |
Source ClinicalTrials.gov
Participant flow9
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Investigational Test Product | 252 | |
| Overall Study | STARTED | Reference Listed Drug | 253 | |
| Overall Study | STARTED | Vehicle | 84 | |
| Overall Study | COMPLETED | Investigational Test Product | 211 | |
| Overall Study | COMPLETED | Reference Listed Drug | 218 | |
| Overall Study | COMPLETED | Vehicle | 75 | |
| Overall Study | NOT COMPLETED | Investigational Test Product | 41 | |
| Overall Study | NOT COMPLETED | Reference Listed Drug | 35 | |
| Overall Study | NOT COMPLETED | Vehicle | 9 |
Source ClinicalTrials.gov
Adverse events474
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 | Lymphadenopathy | Blood and lymphatic system disorders | Investigational Test Product | 1 | 247 | |
| other | Lymphadenopathy | Blood and lymphatic system disorders | Reference Listed Drug | 3 | 249 | |
| other | Lymphadenopathy | Blood and lymphatic system disorders | Vehicle | 0 | 80 | |
| other | Atrial Fibrillation | Cardiac disorders | Investigational Test Product | 1 | 247 | |
| other | Atrial Fibrillation | Cardiac disorders | Reference Listed Drug | 1 | 249 | |
| other | Atrial Fibrillation | Cardiac disorders | Vehicle | 1 | 80 | |
| other | Bradycardia | Cardiac disorders | Investigational Test Product | 0 | 247 | |
| other | Bradycardia | Cardiac disorders | Reference Listed Drug | 1 | 249 | |
| other | Bradycardia | Cardiac disorders | Vehicle | 0 | 80 | |
| other | Cardiac Failure Congestive | Cardiac disorders | Investigational Test Product | 0 | 247 |
1 to 10 of 474Source ClinicalTrials.gov
See all 474 adverse eventsAdverse event totals9
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Investigational Test Product | 1 | 247 |
| Total, all-cause mortality | Reference Listed Drug | 0 | 249 |
| Total, all-cause mortality | Vehicle | 0 | 80 |
| Total, other adverse events | Investigational Test Product | 81 | 247 |
| Total, other adverse events | Reference Listed Drug | 77 | 249 |
| Total, other adverse events | Vehicle | 16 | 80 |
| Total, serious adverse events | Investigational Test Product | 6 | 247 |
| Total, serious adverse events | Reference Listed Drug | 8 | 249 |
| Total, serious adverse events | Vehicle | 1 | 80 |
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 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/NCT01686152
GET https://conductscience.org/api/trials/v1/NCT01686152/events?page=2