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| ID | Type | Description | Link |
|---|---|---|---|
| 16-0302-103 | Other Identifier | De Videnskabsetiske Medicinske Komitéer |
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Photodamaged skin increases the risk of skin cancer, highlighting the need for preventive treatments. Laser-assisted drug delivery (LADD) using ablative fractional lasers (AFL) enhances topical drug delivery and has proven safe and effective. Integrating non-invasive optical imaging techniques with transcriptomic gene expression profiling enables evaluation of the response of different skin layers to such interventions.
It is hypothesized that AFL-assisted delivery of biostimulators exerts synergistic regenerative effects on photodamaged skin, resulting in superior clinical, molecular, and morphological improvements, as well as enhanced epidermal and dermal remodeling, compared with either monotherapy alone. The study aims to provide an in-depth understanding of the individual and combined effects of AFL and biostimulators on the regeneration of photodamaged skin through clinical assessments, non-invasive imaging, and transcriptomic analysis.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Laser-assisted PLLA delivery | Experimental | AFL treatment followed by immediate topical application of PLLA |
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| AFL treatment | Active Comparator | Treatment with AFL alone |
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| Control | No Intervention | No treatment |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Ablative fractional laser | Device | Treatment with AFL on the dorsal part of hand |
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| Measure | Description | Time Frame |
|---|---|---|
| Clinical efficacy | Change from baseline in the overall clinical appearance of photodamage in the treated area will be assessed using a 5-point Global Improvement Score (GIS) ranging from 0 to 4, where 0 indicates no improvement and 4 indicates >75 % improvement. Assessments will be performed by the on-site investigator and independent blinded physicians based on standardized clinical photographs. | Baseline to Week 36 |
| Measure | Description | Time Frame |
|---|---|---|
| Transcriptomic response | Changes in gene expression profiles will be assessed by transcriptomic analysis of tape-strip samples collected before and after treatment and compared between intervention arms. | Baseline to Week 36 |
| Safety of interventions |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Bispebjerg Hospital | Copenhagen | Capital Region | 2400 | Denmark |
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| ID | Term |
|---|---|
| D012871 | Skin Diseases |
| ID | Term |
|---|---|
| D017437 | Skin and Connective Tissue Diseases |
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| ID | Term |
|---|---|
| D054020 | Lasers, Gas |
| ID | Term |
|---|---|
| D007834 | Lasers |
| D055096 | Optical Devices |
| D004864 | Equipment and Supplies |
| D055618 | Radiation Equipment and Supplies |
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This study is designed as a prospective, randomized, within-subject, translational exploratory study. Participants will receive treatment on the dorsal sides of both hands. Within each participant, one hand will be randomly assigned to treatment with AFL alone, while the contralateral hand will be assigned to treatment with AFL followed by immediate topical application of PLLA. Each hand will also include an untreated control site, allowing for intra-individual comparisons of treatment effects.
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Blinded assessors will be reviewing and scoring the clinical photos after the study is completed.
| Poly-L-Lactic Acid | Device | Following AFL, PLLA will be applied to the same area |
|
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Safety will be evaluated by the incidence, severity, and relationship to treatment of Adverse Events (AEs) and Serious Adverse Events (SAEs) throughout the study period.
AEs and SAEs will be recorded continuously at each study visit and assessed by the investigator.
| Baseline to week 36 |
| Pain assessment | Pain associated with each intervention will be assessed using a patient-reported Numeric Rating Scale (NRS) ranging from 1 to 10, where 1 indicates minimal pain and 10 indicates the worst imaginable pain. | Baseline to Week 36 |
| Patient-reported improvement | Perceived improvement will be assessed using a 5-point improvement scale ranging from 0 to 4, where 0 indicates no improvement and 4 indicates the greatest possible improvement. | From baseline to Week 36 |
| Patient satisfaction | Patient satisfaction will be assessed using a 5-point satisfaction scale ranging from -2 to +2, where -2 indicates very dissatisfied, 0 indicates neutral, and +2 indicates very satisfied. | Baseline to Week 36 |