Can a special sunscreen stop skin spots from turning dangerous?
NCT ID NCT07335003
First seen Jun 27, 2026 · Last updated Jun 27, 2026
Summary
This study tests whether a new sunscreen, Anthelios Fluide 100 KA+ UVMune 400, can help prevent actinic keratosis—rough, scaly patches that can turn into skin cancer—in people aged 60 and older who already have many of these spots. Eighty participants will be randomly assigned to use the sunscreen daily or follow standard sun protection. The main goal is to see if the sunscreen reduces the number of new lesions over time.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- Anthelios Fluide 100 KA+ UVMune 400 sunscreen
- What this could lead to
- If it works, this could show that a specific sunscreen helps prevent actinic keratosis lesions from forming or worsening.
- What could go wrong
- This is a small, early-stage study (80 people) testing a cosmetic product, not a drug. Results may not apply to everyone, and the benefit over standard sun protection is uncertain.
This is an AI summary of the original study and may miss details. Read our disclaimer.
Study facts
What this study's own registry entry says, in plain language.
- Phase
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Not a phased trial
Phase numbers describe drug development. The registry uses this when they do not apply, as it does for trials of devices, procedures or behaviour changes, and for observational studies.
- Participants
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About 80 people
The number the study aims to enrol. It can still change while the study runs.
- Started
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Jul 2025
- Expected to finish
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Mar 2029
An estimate. End dates often move.
- Lead sponsor
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A company
The lead sponsor is a pharmaceutical, biotech, or medical-device company.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
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60 years and older
- Sex
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Anyone
- Healthy volunteers
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Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
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.
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
How to take part
Only the study team decides who joins. These are the ways to reach them.
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The places running it
1 site. The list below names each one and where it is.
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The official record
ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.
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A doctor treating you
A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.
Contacts and locations
Locations
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Sydney Melanoma Diagnostic Centre, Royal Prince Alfred Hospital
RECRUITINGCamperdown, New South Wales, 2050, Australia
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Other studies related to the condition(s) this trial covers.
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