The efficacy and safety of a medical device sunscreen for the prevention and reduction of skin damage caused by excessive sun exposure
Phase 2
- Conditions
- Prevention and reduction of actinic keratosis in patients with epidermal skin damage and increase in skin qualitySkin and Connective Tissue Diseases
- Registration Number
- ISRCTN90748112
- Lead Sponsor
- 3SKIN AS
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Ongoing
- Sex
- All
- Target Recruitment
- 80
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 1-22. In the judgement of the Investigator are in good general health based on medical history3. Both genders; males and females4. Aged 18-75 yearsHealthy volunteers:1. Both genders; males and females2. Aged 18-75 years
Exclusion Criteria
- 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 photosensitivity3. Known hypersensitivity or allergy to any of the substances under study4. Porphyria5. Use of any photosensitising drugs6. Immunocompromised or immunosuppressed subjects for any idiopathic, disease-specific or therapeutic reasons7. 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 randomisation9. Open wounds on the face10. Concurrent use of any vitamin D3 supplement during the trial11. 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 randomisation12. Known pregnancy or nursing mothers13. Any clinically unstable medical conditions (e.g. recent diagnosis of a concomitant disease), at the discretion of the Investigator14. 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 Investigator15. Prior participation in this study
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method 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 weeks2. AK severity measured using the modified actinic keratosis and severity index (mAKASI) score (0-10.8) at baseline and after 3 months +-2 weeks3. Total (AK) lesion count (TLC) clinically measured at baseline and after 3 months +-2 weeks4. Dermatoscopic grade of AK, as per Zalaudek (2014), measured at baseline and after 3 months +-2 weeks
- Secondary Outcome Measures
Name Time Method