Clinical trial · Interventional
A Pre-market Study to Evaluate the Performance and Safety of a Skin Preparation Device for Removal of Dry Crusty Skin
A Single-center, Open, Randomized, Non-controlled, Comparative Pre-market Investigation to Evaluate the Performance of a Skin Preparation Device for Removal of Hyperkeratotic Skin
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (7)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Actinic Lesion | — | UNRESOLVED | — |
| Hyperkeratosis | — | UNRESOLVED | — |
| Hyperkeratotic Actinic Keratosis | — | UNRESOLVED | — |
| Hyperkeratotic Callus | — | UNRESOLVED | — |
| Hyperkeratotic; Lesion | — | UNRESOLVED | — |
| Keratosis, Actinic | — | UNRESOLVED | — |
| Solar Keratosis/Sunburn | — | UNRESOLVED | — |
Interventions
Interventions (3)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| GMDN 47102 / Electrode Skin Abrasive Pad | Device | — | UNRESOLVED |
| Investigational Skin Preparation Device | Device | — | UNRESOLVED |
| UMDNS 13-230 / Biopsy punch (Dermal Curette) | Device | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- ACTIVE_COMPARATOR
- label
- Investigational Skin Preparation Device versus Disposable Dermal Curette
- interventionNames
- Device: Investigational Skin Preparation Device
- Device: UMDNS 13-230 / Biopsy punch (Dermal Curette)
- type
- ACTIVE_COMPARATOR
- label
- Investigational Skin Preparation Device versus Abrasive Pad for Skin Preparation
- interventionNames
- Device: Investigational Skin Preparation Device
- Device: GMDN 47102 / Electrode Skin Abrasive Pad
Primary outcomes (1)
- measure
- Grade of hyperkeratotic skin removal
- timeFrame
- Day 0
- description
- 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.
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
- Maximum age
- 100 Years
Show eligibility criteria text
Inclusion Criteria: * Attending the clinic for treatment of actinic keratosis using daylight photodynamic therapy * Age: 18 - 100 years. * Available for two follow-up visits: two weeks after treatment and 4 months after treatment * Provision of informed consent i.e., subject must be able to understand and sign the patient Information and Consent Form * Subject have been informed on the nature, the scope and the relevance of the study Exclusion Criteria: * Known or suspected allergy/hypersensitivity to phenol formaldehyde * Wound at the skin site to be treated * Documented skin disease at the time of enrollment, as judged by the investigator * Previously enrolled in the present investigation * Inclusion in other ongoing investigations simultaneously that would preclude the subject from participating in this investigation as judged by the investigator * Actinic keratosis treatment obtained within last 6 months * Involvement in the planning and conduct of the clinical investigation (applies to all investigation site staff and third party vendor) * Any subject that according to Medical Research Act, paragraphs 7-10, is deemed unsuitable for study enrolment. * Complications that would increase wound risks if investigational product would be used.
References
Publications (0)
Data not yet available