The subjects who will participate in the clinical study will have actinic keratoses and/or superficial basal cell carcinoma that need to be treated by dynamic phototherapy.
Conditions
Interventions
Product Name: Cicabio crème
Product Code: Not applicable: cosmetic product commercialised
Pharmaceutical Form: Cutaneous emulsion
Sponsors
Laboratoire BIODERMA
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: - Subject aged of more than 18 years. - Subject who has to make dynamic phototherapy session to treat actinic keratosis and/or superficial basal cell carcinoma. - Subject who has accepted not to be exposed to UV during the whole study and at least 3 months after the end of the study. Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: - Pregnant or breast-feeding women. - Subject with cutaneous or medical illness that might prevent the subject to be included in the study, according to the investigator. - Documented allergies to study product components.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To assess the tolerance of Cicabio crème after a treatment with dynamic phototherapy.;Secondary Objective: To assess the action of Cicabio crème on the cutaneous state and the subjective signs produced by dynamic phototherapy sessions.;Primary end point(s): - To assess the tolerance to the study product. - To assess the cutaneous state and the subjective signs generated by the dynamic phototherapy. | — |
Countries
Belgium
Outcome results
None listed