Clinical trial · Interventional
Measuring Adherence To Topical 5-Fluorouracil in a Clinic Population
NCT00696488CI-TRIAL-00034762completedPhase 4Results postedClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
The purpose of this research study is to measure adherence to the study drug (Carac) for the treatment of actinic keratoses.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Actinic Keratosis | — | UNRESOLVED | — |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Fluorouracil 0.5% | Drug | Fluorouracil | ALIAS |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Fluorouracil 0.5%
- description
- each subject will receive the study medication: Carac® 0.5% Fluorouracil, a standard treatment for actinic keratoses. Carac® will be dispensed to the subjects in the original tube with MEMS electronic monitoring caps attached. Subjects will be asked to apply the medication daily to AK lesions
- interventionNames
- Drug: Fluorouracil 0.5%
Primary outcomes (1)
- measure
- Adherence to Carac® in Subjects With Moderate to Severe Actinic Keratosis.
- timeFrame
- 12 weeks
- description
- Measure of adherence by MEMS caps and the % of total prescribed doses that were actually used
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 50 Years
Show eligibility criteria text
Inclusion Criteria: * Any male or female 50 years of age or older with moderate to severe actinic keratoses of the face and anterior scalp diagnosed by a dermatologist will be eligible for participation. Exclusion Criteria: * Age less than 50. * Known allergy or sensitivity to topical Carac® in the subject. * Inability to complete all study-related visits. * Introduction of any other prescription medication, topical or systemic, for actinic keratosis while participating in the study. * Subjects should not receive surgical or cryotherapy while participating in the study. * Pregnant women, women who are breast feeding, or women of child bearing potential who are not practicing two acceptable methods of birth control
References
Publications (1)
- DERIVEDYentzer B, Hick J, Williams L, Inabinet R, Wilson R, Camacho FT, Russell GB, Feldman SR. Adherence to a topical regimen of 5-fluorouracil, 0.5%, cream for the treatment of actinic keratoses. Arch Dermatol. 2009 Feb;145(2):203-5. doi: 10.1001/archdermatol.2008.562. No abstract available. PMID 19221274