Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Class |
|---|---|
| Clinius Ltd | INDUSTRY |
Not provided
Not provided
Not provided
Not provided
In this clinical one-site investigation the performance and safety of a skin preparation device will be evaluated for removing hyperkeratotic skin prior to further medical treatment. Comfort and pain during skin preparation, as well as performance and safety of device, will be compared to comparators on separate skin areas for every subject.
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Investigational Skin Preparation Device versus Disposable Dermal Curette | Active Comparator |
| |
| Investigational Skin Preparation Device versus Abrasive Pad for Skin Preparation | Active Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Investigational Skin Preparation Device | Device | Removal of hyperkeratotic skin with Investigational Skin Preparation Device |
|
| Measure | Description | Time Frame |
|---|---|---|
| Grade of hyperkeratotic skin removal | Sufficient hyperkeratotic skin removal in comparison to comparative methods. The removal of hyperkeratotic skin is assessed visually and by palpation. Removal of hyperkeratotic skin measurement grades: All hyperkeratotic skin removed, Partial hyperkeratotic skin removed, None hyperkeratotic skin removed. | Day 0 |
| Measure | Description | Time Frame |
|---|---|---|
| Grade of injury to skin / grade of skin irritation / grade of allergic skin reaction | Investigator assessment of adverse effects on skin in comparison to the comparative methods. Grade of injury to skin: none, mild, moderate, severe. Grade of skin irritation: none, mild, moderate, severe. Grade of allergic skin reaction: none, mild, moderate, severe. | Day 0 |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Johanna H Hagman, M.D, PhD | Vaasa Central Hospital, Vaasa, Finland | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Vaasa Central Hospital | Vaasa | 65130 | Finland |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| GMDN 47102 / Electrode Skin Abrasive Pad | Device | Removal of hyperkeratotic skin with Abrasive Pad for Skin Preparation |
|
| UMDNS 13-230 / Biopsy punch (Dermal Curette) | Device | Removal of hyperkeratotic skin with Disposable Dermal Curette |
|
| Grade of skin irritation / grade of allergic skin reaction | Investigator assessment of adverse effects on skin in comparison to the comparative methods. Grade of skin irritation: none, mild, moderate, severe. Grade of allergic skin reaction: none, mild, moderate, severe. | 14 day follow-up |
| Duration of operation time per treated skin area | Operation time assessed by the mean difference in time per treated skin area to remove the hyperkeratotic skin in comparison to comparative methods. | Day 0 |
| Presence of actinic keratosis | Presence of actinic keratosis (AK) is measured by number of different grades of AK lesions. Number of different grades of AK lesions: None, Grade I AK lesions, Grade II AK lesions, Grade III AK lesions. | Day 0 |
| Clearance of actinic keratosis | Number of different grades of actinic keratosis (AK) lesions are measured: None, Grade I AK lesions, Grade II AK lesions, Grade III AK lesions. Actinic keratosis clearance is assessed as the number of cleared actinic keratosis lesions at 4th month follow-up divided by the actinic keratosis lesion number at Day 0. Clearance will be reported in %. A high %-value means a high number of cleared lesions. | 4th month follow-up |
| Physician comfort during skin preparation using an investigator questionnaire | Rate of physician comfort when comparing the investigational product versus comparative methods. The endpoint will utilize a questionnaire for the investigator/nurse to fill in. | Day 0 |
| Subject comfort during skin preparation using a subject questionnaire | Rate of subject comfort (including skin sensation and heating of skin) when comparing the investigational product with comparative methods. The endpoint will utilize a questionnaire for the subject to fill in. Skin sensation during skin preparation: Very pleasant, Pleasant, Neutral, Unpleasant, Very unpleasant. Heating of skin during skin preparation: None, Mild temperature rise, Moderate temperature rise, High temperature rise, Burning. | Day 0 |
| Subject pain sensation during skin preparation | Rate of pain using visual analogue scale (VAS). VAS: 0 - 10 (0= No pain and 10 = worst possible pain) | Day 0 |
| Subject pain sensation during daylight photodynamic treatment | Rate of pain using visual analogue scale (VAS). VAS: 0 - 10 (0= No pain and 10 = worst possible pain) | Day 0 |
| ID | Term |
|---|---|
| D055623 | Keratosis, Actinic |
| D013471 | Sunburn |
| D053546 | Keratoderma, Palmoplantar, Epidermolytic |
| ID | Term |
|---|---|
| D011230 | Precancerous Conditions |
| D009369 | Neoplasms |
| D007642 | Keratosis |
| D012871 | Skin Diseases |
| D017437 | Skin and Connective Tissue Diseases |
| D010787 | Photosensitivity Disorders |
| D002056 | Burns |
| D014947 | Wounds and Injuries |
| D015776 | Keratoderma, Palmoplantar, Diffuse |
| D007645 | Keratoderma, Palmoplantar |
| D012873 | Skin Diseases, Genetic |
| D030342 | Genetic Diseases, Inborn |
| D009358 | Congenital, Hereditary, and Neonatal Diseases and Abnormalities |
Not provided
Not provided