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Prevention study for Actinic Keratosis (AK)
Official title Study of the Photoprotection and Prevention of Actinic Damage With Anthelios Fluide 100 KA+ UVMune 400 in Patients With Multiple Actinic Keratoses
ClinicalTrials.gov ID: NCT07335003
What this study is testing
- What it's testing
- Participants will be invited to take part in a research study as they have been diagnosed with multiple actinic keratosis lesions (AK). AK usually present as small, rough, dry, scaly and/or crusty patches or papules of the skin that can be skin-coloured pink, red, tan or a combinationof colours and are often easier to feel than see at their earlier stages.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 60 and older
You may be able to join if
- Adult outpatients ≥ 60y old with at least 11 clinically typical actinic keratosis lesions, including at least one on the face;
- Patient having understood and signed a written informed Consent Form to participate in the study indicating the potential participant's willingness...
You likely can't join if
- Atypical actinic keratosis lesions including suspected squamous cell carcinoma and basal cell carcinoma (could be present at screening and treated...
- History of \>2 squamous cell carcinomas;
- Known history of immunodepression whatever its cause in the past year;
- Participants who cannot undergo skin biopsies, with a history of scarring problems or who have developed adverse effects from the use of local...
- Participant using interferon or interferon inducers, immunomodulators, cytotoxic or immunosuppressive drugs, corticosteroids, retinoids, other...
- Participant having active, localized or systemic infection other than the AK lesions
See the full eligibility criteria
- Adult outpatients ≥ 60y old with at least 11 clinically typical actinic keratosis lesions, including at least one on the face;
- Patient having understood and signed a written informed Consent Form to participate in the study indicating the potential participant's willingness to undergo the study procedures and complete the study.
- Atypical actinic keratosis lesions including suspected squamous cell carcinoma and basal cell carcinoma (could be present at screening and treated but cannot be present at 1st visit);
- History of \>2 squamous cell carcinomas;
- Known history of immunodepression whatever its cause in the past year;
- Participants who cannot undergo skin biopsies, with a history of scarring problems or who have developed adverse effects from the use of local anesthesia will also be excluded.
- Participant using interferon or interferon inducers, immunomodulators, cytotoxic or immunosuppressive drugs, corticosteroids, retinoids, other keratolytics or have received investigational drug within 4 weeks before...
- Participant having active, localized or systemic infection other than the AK lesions
- Participant having any dermatological affection within the treated and adjacent area according to the Investigator judgement
- Participant having a present or past skin condition that according to Investigator judgment, deems inappropriate for study participation
- Participant having other significant medical conditions that according to Investigator Judgment, deems inappropriate for study participation
- Participant having a known hypersensitivity, allergy or contraindication to any ingredients contained within the cosmetic products,
- Participant taking part or intending to take part in another study for 30 days prior to D1 visit, and 30 days following last study visit. that according to Investigator judgment, deems inappropriate or may interfere for...
- Participant using light-based devices such as but not limited to PUVA (Psoralen Ultraviolet A therapy), IPL (Intense Pulsed Light), laser, LED (Light Emitting Diode) devices or tanning beds, within 4 weeks before...
- Participant having applied any topical product on the investigational areas the day of enrolment visit,
- Participant under legal guardianship or incapacitation.
- Participant being psychologically incapable of signing informed Consent Form and unable to comply with the protocol requirements according to investigator judgment.
The study team makes the final eligibility decision.
Where it's taking place
- Camperdown, New South Wales, Australia
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 60 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Camperdown, New South Wales, Australia. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.