Trial · NCT02289768
Study To Evaluate The Efficacy And Safety Of Actikerall® Solution In Patients With Grade I-II Actinic Keratoses
NCT02289768, Phase 3, Completed, Almirall, S.A.
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. Study To Evaluate The Efficacy And Safety Of Actikerall® Solution In Patients With Grade I-II Actinic Keratoses. Trials, record NCT02289768. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT02289768
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Study To Evaluate The Efficacy And Safety Of Actikerall® Solution In Patients With Grade I-II Actinic Keratoses
- NCT number
- NCT02289768
- Status
- Completed
- Phases
- Phase 3
- Enrollment
- 166 participants, actual
- Lead sponsor
- Almirall, S.A.
- Conditions
- Actinic Keratosis
- Interventions
- 5-fluorouracil/salicylic acid, Vehicle
- First posted
- 2014-11-13
- Last updated
- 2016-08-05
- Other registries' IDs
- eudract:2014-001171-31
Source ClinicalTrials.gov
Registered outcomes10
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Percentage of patients with complete clinical clearance of actinic keratosis lesions in the treatment field | Week 20 | Complete Clinical Clearance is defined as no clinically visible actinic keratosis lesions in the selected treatment area |
| Secondary | Percentage of patients with partial clinical clearance of actinic keratosis lesions in the treatment field | Week 20 | Partial clearance is defined as a 75% or greater reduction in the number of clinically visible actinic keratosis lesions in the selected treatment area |
| Secondary | Percentage change from baseline in the total number of actinic keratosis lesions | Week 20 | |
| Secondary | Global assessment of efficacy by the physician (Physician Global Assessment) | Week 20 | |
| Secondary | Change from baseline in total score of the Dermatology Life Quality Index (DLQI) | Week 20 | |
| Secondary | Total score of the patients´ treatment satisfaction questionnaire for medication (TSQM) | Week 20 | |
| Secondary | Percentage of patients with complete clearance of three pre-defined subclinical actinic keratosis lesions | Week 20 | Sub-clinical lesions will be determined using reflectance confocal microscopy in a subset of 30 patients |
| Secondary | Percentage change from baseline in the three selected actinic keratosis subclinical lesions | Week 20 | Sub-clinical lesions will be determined using reflectance confocal microscopy in a subset of 30 patients |
| Secondary | Percentage of patients for which the clearance of one pre-defined representative clinical actinic keratosis lesion is confirmed by reflectance confocal microscopy | Week 20 | Determined using reflectance confocal microscopy in a subset of 30 patients |
| Secondary | The number of patients with adverse events | Week 20 |
Source ClinicalTrials.gov
Outcomes0
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
None in this release.
Results by group0
Each measurement the trial posted, group by group, in the words and numbers it posted.
None in this release.
Participant flow0
How many started, completed or left each group, period by period.
None in this release.
Adverse events0
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
None in this release.
Adverse event totals0
The totals the trial posted for each group.
None in this release.
Papers1
The papers the trial lists on ClinicalTrials.gov.
| PMID | Listed as |
|---|---|
| 27995485 | DERIVED |
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/NCT02289768
GET https://conductscience.org/api/trials/v1/NCT02289768/registered