Clinical trial · Interventional
Evaluating Skin Appearance Following 5-Flourouracil Cream for Treatment of Actinic Keratosis and the Effects of Topical Agents
NCT03279328CI-TRIAL-00039212completedPhase 4ClinicalTrials.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)
This proposed project will be an open-label, split face, randomized controlled pilot study. Up to 60 patients with diffuse facial actinic keratosis will be enrolled in the study. The purpose of this study is to understand the change in skin appearance throughout 5-FU treatment course and to examine whether a topical corticosteroid and moisturizer can decrease severity and duration of skin inflammation after 5-FU treatment course.
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 Keratoses | — | UNRESOLVED | — |
Interventions
Interventions (3)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Skin Barrier Moisturier | Drug | — | UNRESOLVED |
| Topical Steroid Ointment | Drug | — | UNRESOLVED |
| Vaseline | Other | — | UNRESOLVED |
Design
Arms and outcomes
Arms (3)
- type
- ACTIVE_COMPARATOR
- label
- Topical Steroid Ointment
- description
- One side of the face will receive a Topical Steroid ointment twice daily for seven days.
- interventionNames
- Drug: Topical Steroid Ointment
- type
- ACTIVE_COMPARATOR
- label
- Vaseline
- description
- One side of the face will receive Vaseline twice daily for seven days.
- interventionNames
- Other: Vaseline
- type
- ACTIVE_COMPARATOR
- label
- Skin Barrier Moisturizer
- description
- One side of the face will receive Skin Barrier Moisturizer twice daily for seven days.
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * Male and female, at least 18 years of age * Subject must have a diagnosis of actinic keratosis (at least 5 lesions on each side of the face) * Able to comprehend and read the English language Exclusion Criteria: * Subjects who do not fit the inclusion criteria * Concurrently have other inflammatory skin conditions. * Prior known allergy to any components to of 5FU cream, topical steroid ointment or vaseline. • Subject who, in the opinion of the investigator, will be uncooperative or unable to comply with study procedures (i.e.: compliant with using 5-FU cream, topical corticosteroid or moisturizers * Those that are prisoners or cognitively impaired.
References
Publications (0)
Data not yet available
No reference posted for this study.