E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
Photodamaged skin in the décolleté |
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E.1.1.1 | Medical condition in easily understood language |
Sundamaged skin in the chest region |
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E.1.1.2 | Therapeutic area | Analytical, Diagnostic and Therapeutic Techniques and Equipment [E] - Therapeutic techniques [E02] |
MedDRA Classification |
E.1.2 Medical condition or disease under investigation |
E.1.2 | Version | 20.0 |
E.1.2 | Level | LLT |
E.1.2 | Classification code | 10065944 |
E.1.2 | Term | Photodamaged skin |
E.1.2 | System Organ Class | 100000004858 |
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E.1.3 | Condition being studied is a rare disease | No |
E.2 Objective of the trial |
E.2.1 | Main objective of the trial |
In patients with photodamaged skin in the décolleté region, the objective is to investigate a non-ablative fractional thulium laser and a radio-frequency microneedling device as pre-treatment approaches for combination photodynamic therapy in treatment of photoaged skin and actinic keratoses. |
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E.2.2 | Secondary objectives of the trial |
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E.2.3 | Trial contains a sub-study | No |
E.3 | Principal inclusion criteria |
* > 18 years of age. * Décolleté with chronic field-change photodamaged skin. * An area with visually homogenous photodamage. * Provide informed written consent. * Fertile women must provide a negative U-hCG pregnancy test at the time of inclusion, and use safe anticontraceptive during the entire study period, e.g. oral hormonal contraceptives, intrauterine devices, subdermal implantation, or hormonal vaginal ring. |
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E.4 | Principal exclusion criteria |
* Actinic keratoses treatment to the décolleté area within the last 30 days. * Porphyria diagnoses. * Pregnant or nursing women. * Skin cancer (invasive, in situ), keratoacanthoma, or other infiltrating tumors in the study area. * Known tendencies to produce hypertrophic scarring or keloids. |
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E.5 End points |
E.5.1 | Primary end point(s) |
Clinical improvement of photodamage 12 weeks post-treatment. Based on standardized clinical photos, pre- and post-treatment documentation will be compared. An investigator will evaluate the following on a modified validated 5-point categorial scale, i.e. 0 – none, 1 – mild, 2 – moderate, 3 – severe, and 4- very severe: * Overall photodamage * Skin texture * Lentigines and mottled pigmentation * Telangiectasia * Wrinkles
Clinical assessment will be supplemented by: * Blacklight UVA photos * Optical coherence tomography (OCT) for wrinkles and roughness * Reflectance confocal microscopy (RCM) for actinic damage and keratosis, laxity, and solar lentigo |
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E.5.1.1 | Timepoint(s) of evaluation of this end point |
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E.5.2 | Secondary end point(s) |
* Treatment effect on AK lesions after 12 weeks: Percentage reduction in AKs in each treatment area in relation to newly developed lesions since study initiation.
* Severity of local skin reactions (LSR): Redness, edema, scaling, pustules, and crusting following any treatment type. The reactions will be evaluated at every follow-up on a 5-point categorial scale by an investigator, i.e. 0 – none, 1 – mild, 2 – moderate, 3 – severe, and 4- very severe
* Safety: Changes in pigmentation and scarring. Evaluation on a 5-point categorial scale by an investigator, i.e. 0 – none, 1 – mild, 2 – moderate, 3 – severe, and 4- very severe
* Presence of perceived pain during treatment: Evaluation at the patient’s discretion on a numerical scale, i.e. 0-10, 0 being no perceivable pain, and 10 being the worst possible imaginable pain.
* Cosmetic results: Evaluated by both patient and investigator, treatment areas will be evaluated 12 weeks post-treatment on a 5-point categorial scale, i.e. 0 – poor, 1 – acceptable, 2 – good, 3 – excellent, and 4 – outstanding.
* Protoporphyrin IX (PpIX) fluorescence uptake: Quantitative measurement, higher is better.
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E.5.2.1 | Timepoint(s) of evaluation of this end point |
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E.6 and E.7 Scope of the trial |
E.6 | Scope of the trial |
E.6.1 | Diagnosis | No |
E.6.2 | Prophylaxis | No |
E.6.3 | Therapy | Yes |
E.6.4 | Safety | Yes |
E.6.5 | Efficacy | Yes |
E.6.6 | Pharmacokinetic | No |
E.6.7 | Pharmacodynamic | No |
E.6.8 | Bioequivalence | No |
E.6.9 | Dose response | No |
E.6.10 | Pharmacogenetic | No |
E.6.11 | Pharmacogenomic | No |
E.6.12 | Pharmacoeconomic | No |
E.6.13 | Others | No |
E.7 | Trial type and phase |
E.7.1 | Human pharmacology (Phase I) | No |
E.7.1.1 | First administration to humans | No |
E.7.1.2 | Bioequivalence study | No |
E.7.1.3 | Other | No |
E.7.1.3.1 | Other trial type description | |
E.7.2 | Therapeutic exploratory (Phase II) | No |
E.7.3 | Therapeutic confirmatory (Phase III) | No |
E.7.4 | Therapeutic use (Phase IV) | Yes |
E.8 Design of the trial |
E.8.1 | Controlled | Yes |
E.8.1.1 | Randomised | Yes |
E.8.1.2 | Open | Yes |
E.8.1.3 | Single blind | No |
E.8.1.4 | Double blind | No |
E.8.1.5 | Parallel group | No |
E.8.1.6 | Cross over | No |
E.8.1.7 | Other | Yes |
E.8.1.7.1 | Other trial design description |
Evaluations will be performed by blinded investigators |
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E.8.2 | Comparator of controlled trial |
E.8.2.1 | Other medicinal product(s) | No |
E.8.2.2 | Placebo | No |
E.8.2.3 | Other | Yes |
E.8.2.3.1 | Comparator description |
Intra-person study with 4 treatment areas, one of which is an untreated control area. |
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E.8.2.4 | Number of treatment arms in the trial | 2 |
E.8.3 |
The trial involves single site in the Member State concerned
| Yes |
E.8.4 | The trial involves multiple sites in the Member State concerned | No |
E.8.5 | The trial involves multiple Member States | No |
E.8.6 Trial involving sites outside the EEA |
E.8.6.1 | Trial being conducted both within and outside the EEA | No |
E.8.6.2 | Trial being conducted completely outside of the EEA | No |
E.8.7 | Trial has a data monitoring committee | No |
E.8.8 |
Definition of the end of the trial and justification where it is not the last
visit of the last subject undergoing the trial
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E.8.9 Initial estimate of the duration of the trial |
E.8.9.1 | In the Member State concerned years | 0 |
E.8.9.1 | In the Member State concerned months | 9 |
E.8.9.1 | In the Member State concerned days | |