Actinic Keratosis
Conditions
Keywords
Actinic Keratosis, AK
Brief summary
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.
Interventions
DEVICEEryfotona AK-NMSC® cream
Cream, to be applied according to COLIPA standard at 2 mg/cm² in head and neck, twice a day before exposing to sun light morning and around lunchtime (about 4-6 hours later), for up to 6 months.
OTHERSunscreen SPF 50+
Cream, to be applied according to COLIPA standard at 2 mg/cm² in head and neck, twice a day before exposing to sun light morning and around lunchtime (about 4-6 hours later), for up to 6 months.
Sponsors
ISDIN
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Investigator)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Percentage of patients with partial clearance of AK lesions | 6 months | Comparison between treatment groups at the end of the treatment period |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Total number of AK lesions in the treated area (including all lesions present at baseline as well as subclinical lesions which appeared during therapy) | 6 months | Comparison between treatment groups at the end of the treatment period |
| Percentage of patients with improvement (clinical and dermoscopic assessment) of the target area as for the erythema, scaling, pigmentation and follicular plugs | 6 months | Comparison between treatment groups at the end of the treatment period |
| Percentage of patients with changes in the Investigator Global Improvement Index | 6 months | Comparison between treatment groups at the end of the treatment period |
| Percentage of patients with changes in Baseline Severity Index (BSI) | 6 months | Comparison between treatment groups at the end of the treatment period |
| Percentage of patients with improvement in the target AK lesion by using RCM score. | 6 months | Comparison between treatment groups at the end of the treatment period |
| Percentage of patients with clearance and improvement of AK lesions | 6 months | Comparison between treatment groups at the end of the treatment period |
| Percentage of patients compliant to treatment | 6 months | Comparison between treatment groups at the end of the treatment period |
| Percentage of patients which report satisfaction to local tolerability | 6 months | Comparison between treatment groups over time and at the end of the treatment period |
| Number of patients with AEs and local AEs (skin reactions) | 6 months | Comparison between treatment groups over time and at the end of the treatment period |
| Percentage of patients which report satisfaction to treatment | 6 months | Comparison between treatment groups at the end of the treatment period |
| Percentage of patients with improvement in the cancerization filed by RCM score | 6 months | Comparison between treatment groups at the end of the treatment period Validation of a new RCM score |
Countries
Italy
Outcome results
None listed