TerminatedPhase 4

Treatment of Photodamaged Skin of the décolleté

Stopped: The second study arm including radio-frequency microneedling was withdrawn due to availability of newer treatment options.

Denmark12 participantsStarted 2018-09-10

Plain-language summary

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.

Who can participate

Age range

18 Years

Sex

FEMALE

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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.

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Clinical improvement of photodamage

Timeframe: 12 weeks

Trial details

NCT IDNCT03573076

SponsorMerete Haedersdal

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2018-12-18

View on ClinicalTrials.gov More Photodamaged Skin trials