Study Results
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Basic Information
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TERMINATED
PHASE4
12 participants
INTERVENTIONAL
2018-09-10
2018-12-18
Brief Summary
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Detailed Description
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Photochemical treatment with photodynamic therapy
Photodynamic therapy (PDT) is a treatment that uses a photosensitizer drug activated in the skin by light in the visible spectrum. Methyl aminolevulinate (MAL) is a photosensitizing agent with great affinity for dysplastic cells, and transforms into the light-sensitive Protoporphyrin PpIX. When exposed to light, photoactivated PpIX catalyzes a reactive oxygen species reaction, which leads to irreversible cell apoptosis of the dysplastic or neoplastic tissue. PDT can be used as treatment of a wide range of photoaging skin defects including actinic keratoses, and is exceedingly well suited for treatment of larger skin areas. PDT produces cosmetically pleasing results in extension of the excellent AK clearance.
Physical intervention with fractional laser and light-based interventions
Fractional laser and light-based treatments with lasers and microneedles are approaches that can be applied very precisely, and can be used to rejuvenate photodamaged skin.
Laser-treatment for rejuvenation of skin can be achieved using a non-ablative 1927 nm fractionated thulium laser (NAFL), good results have been reported for many aspects of photoaging, and specifically for actinic keratoses with good results. The thulium laser works by creating vertical thermal laser-channels in the skin without the ablative effect to the epidermis. Laser-treatment with the thulium laser may be combined with other treatments like PDT to produce synergistic effects.
Microneedling (MN) is a treatment option in which the skin epidermis is penetrated by closely arranged multiple microneedles. This can induce collagen production and stimulate the release of growth factors, and collagen synthesis and remodeling, producing the effects of rejuvenation. Radio-frequency (RF) microneedling (MN), also known as RF-MN, adds RF making it possible for insulated needles to emit heat at the needle-heads when the epidermis is fully punctured, possibly enhancing the described effects even further. Good results have been reported using MN as skin rejuvenation, and can the treatment be used in conjunction with PDT.
The delicate skin of the décolleté is subject to a high amount of accumulated life-time sun exposure, and is thus highly susceptible to photoaging effects. A mild and effective treatment of photodamaged skin for this particular area is highly desirable, and may be achieved by developing new combination strategies, in which the thulium laser or a microneedling device can be used as effective pre-treatment for PDT. To our knowledge, no previous randomized study has compared the use of the non-ablative thulium laser or microneedling in combination with photodynamic treatment (PDT).
Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
SINGLE
Study Groups
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Thulium laser + photodynamic therapy
Non-ablative Thulium laser (NAFL) + Photodynamic therapy combination treatment
Photodynamic therapy
Photodynamic therapy with Methyl Aminolevulinate creme and red light.
Non-ablative Thulium laser (NAFL)
Non-ablative Thulium laser (NAFL).
RF microneedles + photodynamic therapy
Radio-frequency microneedles (RF-MN) + Photodynamic therapy combination treatment
Photodynamic therapy
Photodynamic therapy with Methyl Aminolevulinate creme and red light.
Radio-frequency microneedles (RF-MN)
Radio-frequency microneedles (RF-MN).
Non-ablative Thulium laser
Non-ablative Thulium laser (NAFL) single treatment
Non-ablative Thulium laser (NAFL)
Non-ablative Thulium laser (NAFL).
RF microneedles
Radio-frequency microneedles (RF-MN) single treatment
Radio-frequency microneedles (RF-MN)
Radio-frequency microneedles (RF-MN).
Control
Control receiving no intervention
No interventions assigned to this group
Interventions
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Photodynamic therapy
Photodynamic therapy with Methyl Aminolevulinate creme and red light.
Non-ablative Thulium laser (NAFL)
Non-ablative Thulium laser (NAFL).
Radio-frequency microneedles (RF-MN)
Radio-frequency microneedles (RF-MN).
Eligibility Criteria
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Inclusion Criteria
* 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.
Exclusion Criteria
* Porphyria.
* 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.
* Allergies against Metvix creme solution, peanuts, or soy.
* Considered unable to follow the study protocol, e.g. alcohol dependence syndrome.
18 Years
FEMALE
No
Sponsors
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Merete Haedersdal
OTHER
Responsible Party
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Merete Haedersdal
Professor, Physician Consultant
Principal Investigators
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Merete Haedersdal, MD
Role: PRINCIPAL_INVESTIGATOR
Bispebjerg Hospital
Locations
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Bispebjerg University Hospital
Copenhagen, Copenhagen NV, Denmark
Countries
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Other Identifiers
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2018-000189-12
Identifier Type: -
Identifier Source: org_study_id
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