Clinical trial · Interventional
Long Term Efficacy and Safety of Eryfotona AK-NMSC® in Patients With Actinic Keratosis
A Randomised Double-blind Parallel-group Study to Evaluate the Long-term Effects of Eryfotona AK-NMSC® Cream in the Treatment of Cancerization Field in Patients With Actinic Keratosis.
NCT01656226CI-TRIAL-00012379unknownPhase 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)
The purpose of this study is to assess the efficacy, safety and tolerability of Eryfotona AK-NMSC® topical application vs Sunscreen on cancerization field of actinic keratosis patients after 6 months of treatment.
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 (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Eryfotona AK-NMSC® cream | Device | — | UNRESOLVED |
| Sunscreen SPF 50+ | Other | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- Eryfotona AK-NMSC® cream
- interventionNames
- Device: Eryfotona AK-NMSC® cream
- type
- OTHER
- label
- Sunscreen SPF 50+
- interventionNames
- Other: Sunscreen SPF 50+
Primary outcomes (1)
- measure
- Percentage of patients with partial clearance of AK lesions
- timeFrame
- 6 months
- description
- Comparison between treatment groups at the end of the treatment period
Secondary outcomes (11)
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: 1. Current diagnosis of AK, with ≥4 lesions located in the same anatomical district (within a contiguous 50 cm2 area on the face, bold scalp or forehead); 2. Female or male \>18 years of age; 3. Skin type I or II according to Fitzpatrick; 4. Patient has confirmed his/her willingness to participate in this study;. Exclusion Criteria: 1. Topical drug therapy for AK within the past 3 months or for photoaging in the last 6 months, or had lesion-directed therapy within 2 cm2 of the selected AK area during the previous month; 2. Suitable for surgical, photodynamic or any other topical treatment in the next 6 months; 3. Subjects who suffer/ had suffered from skin cancer or show an early stage of skin cancer or have a genetic predisposition for skin cancer; 4. Other skin disease that requires treatment with other medications in the treatment area or in the distance of 3 cm; 5. Immunosuppression or current treatment for cancer; 6. Clinically unstable medical condition; 7. High risk group for HIV infection or presentation of other infectious diseases 8. Presentation of contact allergies or allergies to compounds of the test substances; 9. Smoker (more than forty cigarettes per day) or heavy drinker (more than three standard drinks per day); 10. Psychiatric disease that may interfere with follow up of study procedures; 11. Participation in other clinical trials up to 30 days prior to day 1 of the study 12. Prior treatment with study medication in the area to be treated; 13. Considered by the investigator, for any other reason, to be an unsuitable candidate for the study.
References
Publications (0)
Data not yet available
No reference posted for this study.