Seborrheic keratosis Skin and Connective Tissue Diseases Seborrheic keratosis
Conditions
Interventions
Interventions as of 15/06/2016:
A total of 8 lesions per subject are identified at visit 1 (day 1), 5 of them are allocated to artemether treatment and 3 serve as reference lesions. Artemether 3% is t
Sponsors
EpiPharm AG
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Age above 40 years old 2. Phototype II, III and IV 3. At least 8 flat or slightly elevated SK lesions with a “pasted-on” look and typical characteristics 4. Lesion size: longest axis (dimension) 2 mm to 10mm 5. Willingness to participate in the study and to comply with the study protocol 6. Written informed consent
Exclusion criteria
Exclusion criteria: 1. Presence of pregnancy, lactation, childbearing potential without contraception 2. Female participants of childbearing potential not using and not willing to continue using a medically reliable method of contraception 4. SK lesion close to the eye or mucosa (mouth, genitals) 5. Lesion in a skin fold or an area where clothing (e.g. belt) may cause physical irritation 6. Pedunculated, verrucous, papilomatous and irritated lesions 7. Presence of clinically significant skin or systemic disease 8. Pathological findings at screening (melanoma, lentigo maligna, inflammation, bleeding) 9. Concomitant participation in another study 10. Traveling to regions with endemic malaria 11. Previous use of treatment of the lesions within 2 years prior to visit 1 12. Known or suspected non-compliance, drug or alcohol abuse 13. Inability to follow the procedures of the study, e.g. due to language problems, psychological disorders, dementia, etc. of the participant 14. Enrolment of the investigator, his/her family members, employees and other dependent persons
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 1. Regression of lesions by assessing the lesions with a 6-point IGA (Investigator Global Assessment) Score at baseline, 56 and 85 days 2. Reduction of lesion size by measuring the longest axis (mm) of the lesion at baseline visit (V1) and at baseline, 56 and 85 days | — |
Secondary
| Measure | Time frame |
|---|---|
| therapy outcome, i.e. the IGA (investigator global assessment) score and lengths of treated lesions versus reference (not treated) lesions at 56 and 85 days. | — |
Countries
Switzerland
Contacts
Public ContactRosemarie Sift Carter
Outcome results
None listed