Photoprotection with Anthelios Fluide 100 KA+ UVMune 400 for people with multiple actinic keratoses

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This randomized interventional study enrolls adults aged 60 and older who have at least 11 clinically typical actinic keratoses, including at least one on the face. Participants are randomly assigned to either daily application of Anthelios Fluide 100 KA+ UVMune 400 with reinforced sun-protection behaviors or to a control group. Study procedures include regular skin examinations and may include biopsies to document lesion status and actinic damage over time. The main aim is to determine whether the investigational sunscreen combined with sun-protection habits reduces new or progressive actinic damage compared with control.

Why it matters

Who can join: the full rules

Inclusion Criteria:

1. Adult outpatients ≥ 60y old with at least 11 clinically typical actinic keratosis lesions, including at least one on the face;
2. 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.

Exclusion Criteria:

1. 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);
2. History of \>2 squamous cell carcinomas;
3. Known history of immunodepression whatever its cause in the past year;
4. 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.
5. Participant using interferon or interferon inducers, immunomodulators, cytotoxic or immunosuppressive drugs, corticosteroids, retinoids, other keratolytics or have received investigational drug within 4 weeks before enrolment
6. Participant having active, localized or systemic infection other than the AK lesions
7. Participant having any dermatological affection within the treated and adjacent area according to the Investigator judgement
8. Participant having a present or past skin condition that according to Investigator judgment, deems inappropriate for study participation
9. Participant having other significant medical conditions that according to Investigator Judgment, deems inappropriate for study participation
10. Participant having a known hypersensitivity, allergy or contraindication to any ingredients contained within the cosmetic products,
11. 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 study participation
12. 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 enrolment.
13. Participant having applied any topical product on the investigational areas the day of enrolment visit,
14. Participant under legal guardianship or incapacitation.
15. Participant being psychologically incapable of signing informed Consent Form and unable to comply with the protocol requirements according to investigator judgment.

Where it's running

• Sydney Melanoma Diagnostic Centre, Royal Prince Alfred Hospital
  Camperdown, New South Wales, Australia Recruiting

Study contacts

• Study coordinator: Pascale GUITERA, MD, Derm
• Email: pascale@guitera.com
• Phone: +61 02 9515 8537

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

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• Topical tirbanibulin (Klisyri) for actinic keratoses with downward-directed growth

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.