Treatment of Photodamaged Skin of the décolleté

July 8, 2020 updated by: Merete Haedersdal

Treatment of Photodamaged Skin of the décolleté With Fractional Laser, Radio-frequency Microneedling, and Photodynamic Therapy

This study investigates a non-ablative fractional thulium laser and a radio-frequency microneedling device as pre-treatment for combination photodynamic therapy in treatment of photoaged skin and actinic keratoses.

Study Overview

Detailed Description

Photoaging of skin and actinic keratoses Photoaging of the skin is the result of UV radiation in chronic sun exposure and its deleterious effects. Photoaging includes fine and coarse wrinkles, roughness, laxity, mottled pigmentation, coarseness, sallowness, telangiectasia, solar lentigines and dysplastic actinic keratoses. The process can be of both cosmetic and medical importance. Actinic keratoses (AK) are common dysplastic pre-malignant lesions that may develop into a malign invasive squamous cell carcinomas (SCC). SCCs have metastatic potential at up to 3%. The risk of malign transformation from AK to SCC is highest in chronic sun-damaged skin with confluent field-cancerization from multiple AK. National guidelines recommend treatment of the entire field of sun damaged skin with photodynamic therapy and several topical drugs, e.g. imiquimod, diclofenac, ingenol mebutate, and 5-fluoruracil. Repeat treatments are usually necessary to achieve the desired results in patients with chronic sun damaged skin.

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).

Study Type

Interventional

Enrollment (Actual)

12

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

    • Copenhagen NV
      • Copenhagen, Copenhagen NV, Denmark, 2400
        • Bispebjerg University Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

16 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Description

Inclusion Criteria:

  • Décolleté with chronic field-change photodamaged skin.
  • 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:

  • Treatment of actinic keratoses in the décolleté area within the last 30 days.
  • 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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Thulium laser + photodynamic therapy
Non-ablative Thulium laser (NAFL) + Photodynamic therapy combination treatment
Photodynamic therapy with Methyl Aminolevulinate creme and red light.
Non-ablative Thulium laser (NAFL).
Experimental: RF microneedles + photodynamic therapy
Radio-frequency microneedles (RF-MN) + Photodynamic therapy combination treatment
Photodynamic therapy with Methyl Aminolevulinate creme and red light.
Radio-frequency microneedles (RF-MN).
Active Comparator: Non-ablative Thulium laser
Non-ablative Thulium laser (NAFL) single treatment
Non-ablative Thulium laser (NAFL).
Active Comparator: RF microneedles
Radio-frequency microneedles (RF-MN) single treatment
Radio-frequency microneedles (RF-MN).
No Intervention: Control
Control receiving no intervention

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Clinical improvement of photodamage
Time Frame: 12 weeks
5-point categorial scale of photodamage severity, measuring changes in skin texture, pigmentation, telangiectasia, and wrinkles. Scores are 0, 1, 2, 3, and 4, for none, mild, moderate, severe, and very severe, respectively. A reduction in score from initial scoring to post-treatment is desirable.
12 weeks

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Treatment effect on actinic keratoses
Time Frame: 12 weeks
Evaluated on the Olsen grading scale for actinic keratoses thickness. Scores are 1, 2, and 3, for slightly palpable, moderately thick, and very thick and hyperkeratotic, respectively. A reduction in score from initial scoring to post-treatment is desirable.
12 weeks
Severity of local skin reactions
Time Frame: 7 days

Local skin reaction (LSR)-grading scale. Evaluation of redness, scaling, edema, pustules, and erosion on a 5-point categorial scale of severity. Scores are 0, 1, 2, 3, and 4, for individual parameters:

Redness: None, slightly pink <50%, pink or light red >50%, red restricted to treatment area, and red extending outside treatment area.

Scaling: None, isolated scale, scaling <50%, scaling >50%, scaling extending outside treatment area.

Edema: None, slight specific edema, palpable edema beyond individual lesions, confluent and/or visible edema, and marked swelling extending outside treatment area.

Pustules: None, vesicles only, transudate or pustules <50%, transudate or pustules >50%, and transudate or pustules extending outside treatment area.

Erosion: None, lesion specific erosion, erosion extending beyond individual lesion, erosion >50%, and black eschar or ulceration.

7 days
Presence of perceived pain during treatment
Time Frame: 0 days
VAS Visual analogue scale for perceived pain. Scores are 1, 2, 3, 4, 5, 6, 7, 8, 9, and 10, ranging from none to very severe. Higher is worse, and lower scores for treatment modalities are desirable.
0 days
Cosmetic results
Time Frame: 12 weeks
Cosmetic results on a 5-point categorial scale for perceived cosmetic outcome compared with base starting point for the individual patient. Scores are 0, 1, 2, 3, and 4, for poor, acceptable, good, excellent, and outstanding, respectively. A higher score is desirable.
12 weeks
Protoporphyrin IX (PpIX) fluorescence uptake
Time Frame: 0 days
Levels of PpIX uptake in the skin computed quantitatively from PpIX imaging. Imaging before application, after 3 hours, and after LED exposure.
0 days
Safety including wounding, scarring, hyper and hypo pigmentation
Time Frame: 12 weeks
Safety concerning side-effects evaluated on a 5-point categorial scale for hyper- and hypopigmentation, erosions, and scarring. Scores are 0, 1, 2, 3, and 4, for none, mild, moderate, severe, and very severe. A lower score is desirable.
12 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Investigators

  • Principal Investigator: Merete Haedersdal, MD, Bispebjerg Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

September 10, 2018

Primary Completion (Actual)

December 18, 2018

Study Completion (Actual)

December 18, 2018

Study Registration Dates

First Submitted

June 6, 2018

First Submitted That Met QC Criteria

June 19, 2018

First Posted (Actual)

June 29, 2018

Study Record Updates

Last Update Posted (Actual)

July 10, 2020

Last Update Submitted That Met QC Criteria

July 8, 2020

Last Verified

July 1, 2020

More Information

Terms related to this study

Other Study ID Numbers

  • 2018-000189-12

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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