Clinical trial · Interventional
5fluorouracil for Advanced Photoaging
Phase III Comparative Study About the Use of 5% 5-fluorouracil Cream Versus Its Utilization as Agent for Sequential Superficial Peeling in the Treatment of Advanced Photoaging
- 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)
It is well known the efficacy of 5% 5-fluoruracil for multiple and superficial actinic keratosis (AKs)treatment. Recently its additional benefit for advanced and severe photoaging while treating Aks was reported. The aim of this study is to compare the efficacy and safety of the two modalities of 5% 5-FU use for forearms photoaging.
Conditions
Conditions (2)
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 | — |
| Photoaging | — | UNRESOLVED | — |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| 5-fluoruracil | Drug | Fluorouracil | ALIAS |
Design
Arms and outcomes
Arms (2)
- type
- ACTIVE_COMPARATOR
- label
- 5% 5-fluoruracil cream
- description
- 30 patients will use 5% 5-fluoruracil cream, twice a day, during 3 weeks, in one randomized forearm
- interventionNames
- Drug: 5-fluoruracil
- type
- ACTIVE_COMPARATOR
- label
- 5% 5-fluoruracil peeling
- description
- The same 30 patients will be submitted to 4 applications of 5% 5-fluoruracil superficial peeling in the other forearm
- interventionNames
- Procedure: 5-fluoruracil
Primary outcomes (2)
- measure
- Change in Photographic Evaluation
- timeFrame
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 50 Years
- Maximum age
- 75 Years
Show eligibility criteria text
Inclusion Criteria: 1. Healthy Men and women, aged from 50 to 75 anos; 2. Phototype I a III (Fitzpatrick Classification); 3. Advanced photoaging on forearms, with multiple superficial actinic keratosis; 4. Agreement with no sun exposure during the study and 5. Agreement with study conditions,capacity to understand and follow the orientations and form consent signature. Exclusion Criteria: 1. Topical treatment with: * tretinoin in the last 6 months ; * other retinoids, alpha-hydroxyacids, poli-hydroxyacids, beta-hydroxyacids and ascorbic acid in the last 3 months; 2. Treatment by chemical peeling, microdermabrasion and non-ablative laser in the last 3 months; 3. Treatment with systemic retinoid in the last 6 months ; 4. Chemotherapy in the last 3 months; 5. Hypersensibility to parabens; 6. Infectious or inflammatory dermatosis on forearms; 7. Clinical evidence of immunosuppression and 8. Presence of photodermatosis
References
Publications (0)
Data not yet available