Prevention and reduction of actinic keratosis in patients with epidermal skin damage and increase in skin quality Skin and Connective Tissue Diseases
Conditions
Interventions
The patient is given a randomised number by Viedoc. After all assessments have been done, the patient is given instructions on how to use the device and will leave with the corresponding device as to
Sponsors
3SKIN AS
Eligibility
Sex/Gender
All
Age
18 Years to 75 Years
Inclusion criteria
Inclusion criteria: Patients: 1. Clinical (visual inspection and palpation) diagnosis of sun-damaged skin of the face with clinically typical, visible, and distinct facial AK lesion(s); Olsen global lesion scale grade 1-2 2. In the judgement of the Investigator are in good general health based on medical history 3. Both genders; males and females 4. Aged 18-75 years Healthy volunteers: 1. Both genders; males and females 2. Aged 18-75 years
Exclusion criteria
Exclusion criteria: 1. Current, active skin cancer on the face; melanoma or non-melanoma (e.g. basal cell carcinoma (BCC), squamous cell carcinoma (SCC), Bowen’s disease) 2. History of photosensitivity 3. Known hypersensitivity or allergy to any of the substances under study 4. Porphyria 5. Use of any photosensitising drugs 6. Immunocompromised or immunosuppressed subjects for any idiopathic, disease-specific or therapeutic reasons 7. Use of any systemic or topical immunosuppressive treatment (e.g. corticosteroids, systemic retinoids, chemotherapy) 8. Any topical treatment of sun-damaged skin or AK on the face (incl. medication, cryotherapy, curettage, photodynamic therapy, UV therapy, excision surgery, chemical peeling (e.g. retinol or other acids) in the 28 days prior to randomisation 9. Open wounds on the face 10. Concurrent use of any vitamin D3 supplement during the trial 11. Participation in any trial with an investigational device or drug in the last 28 days (or 5x half-life of an investigational medicinal product; whichever is the longest) prior to randomisation 12. Known pregnancy or nursing mothers 13. Any clinically unstable medical conditions (e.g. recent diagnosis of a concomitant disease), at the discretion of the Investigator 14. Expected poor protocol compliance or any mental or psychiatric co-morbidities that may interfere with the study procedures or assessments in the opinion of the Investigator 15. Prior participation in this study
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| All measured at the start and end of the study/Visit 1 and Visit 2: 1. Actinic keratosis (AK) severity clinically assessed, as per Olsen grading system: 0-3, at baseline and after 3 months +-2 weeks 2. AK severity measured using the modified actinic keratosis and severity index (mAKASI) score (0-10.8) at baseline and after 3 months +-2 weeks 3. Total (AK) lesion count (TLC) clinically measured at baseline and after 3 months +-2 weeks 4. Dermatoscopic grade of AK, as per Zalaudek (2014), measured at baseline and after 3 months +-2 weeks | — |
Secondary
| Measure | Time frame |
|---|---|
| Efficacy measurements: 1. Intensity, low echogenic band and skin thickness measured using Dermalab Combo by Cortex ultrasound device at baseline and after 3 months +-2 weeks 2. Elasticity of the skin, retraction time, viscoelasticity and Youngs Modulus measured using Dermalab Combo by Cortex cutometer at baseline and after 3 months +-2 weeks 3. Cosmetic outcome assessed by Investigator using the Fitzpatrick wrinkle scale (FWS) at baseline and after 3 months +-2 weeks 4. Quality of life in relation to the patient's skin measured using the Dermatology Life Quality Index (DLQI) questionnaire at baseline and after 3 months +-2 weeks 5. Cosmetic outcome reported by subject using questionnaire after 3 months +-2 weeks 6. Overall treatment satisfaction reported by the subject after 3 months +-2 weeks Safety measurements: 7. Adverse events (including adverse events of special interest, such as pain, burning, stinging, prickling sensations, erythema, itching) recorded by the patient during the study (3 months +-2 weeks) 8. Local skin reaction score (assessed by the investigator) - components: erythema, flaking/scaling, crusting, swelling, vesiculation/pustulation, erosions (ulcerations) grades: 0 = absent, 1 = mild, 2 = moderate, 3 = severe - measured at baseline and after 3 months +-2 weeks 9. Tolerability reported by subject using a verbal rating scale (VRS), categories 0-10 for pain, burning, stinging, prickling sensations, erythema and itching - recorded during the study (3 months +-2 weeks) | — |
Countries
Norway
Contacts
Public ContactOscar Solér
Outcome results
None listed