Photodamaged skin in the décolleté MedDRA version: 20.0 Level: LLT Classification code 10065944 Term: Photodamaged skin System Organ Class: 100000004858
Conditions
Interventions
Trade Name: Metvix
Pharmaceutical Form:
INN or Proposed INN: methyl aminolevulinate
Other descriptive name: METHYL AMINOLEVULINATE HYDROCHLORIDE
Sponsors
Bispebjerg Hospital
Eligibility
Sex/Gender
All
Inclusion criteria
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. Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range 24 F.1.3 Elderly (>=65 years) no F.1.3.1 Number of subjects for this age range
Exclusion criteria
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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: 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.;Secondary Objective: Not applicable; 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 ;Timepoint(s) of evaluation of this end point: 12 weeks post treatment | — |
Secondary
| Measure | Time frame |
|---|---|
| Timepoint(s) of evaluation of this end point: 12 weeks post treatment; 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. | — |
Countries
Denmark
Contacts
Public ContactDermatologisk forskningsafdeling
Bispebjerg Hospital
Outcome results
None listed