Actively Recruiting
Study of the Photoprotection and Prevention of Actinic Damage With Anthelios Fluide 100 KA+ UVMune 400 in Patients With Multiple Actinic Keratoses
Led by Cosmetique Active International · Updated on 2026-01-12
80
Participants Needed
1
Research Sites
191 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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. AK are commonly diagnosed in adults, particularly in patients aged 45 years and older and are considered to be pre-cancerous lesions. The research is aiming to investigate the protective effect of an investigational sunscreen known as Anthelios Fluide 100 KA+ UVMune 400, when used together with good sun protection habits (which include staying in the shade during the hours of 11 am and 3 pm, wearing sun-protective clothing, wearing a wide-brimmed hat) in participants with multiple Actinic keratoses's. Eligible participants will be randomly assigned into 1 of 2 groups - an intervention or control group The study main objective is to evaluate tested sunscreen prevention on actinic keratosis lesions.
CONDITIONS
Official Title
Study of the Photoprotection and Prevention of Actinic Damage With Anthelios Fluide 100 KA+ UVMune 400 in Patients With Multiple Actinic Keratoses
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Adults aged 60 years or older with at least 11 typical actinic keratosis lesions, including at least one on the face
- Able and willing to understand and sign informed consent to participate in the study
You will not qualify if you...
- Presence of atypical actinic keratosis lesions including suspected squamous cell carcinoma or basal cell carcinoma at first visit
- History of more than 2 squamous cell carcinomas
- Known immune system suppression in the past year
- Unable to undergo skin biopsies or history of scarring problems or adverse reactions to local anesthesia
- Using interferon, immunomodulators, cytotoxic or immunosuppressive drugs, corticosteroids, retinoids, keratolytics, or investigational drugs within 4 weeks before enrollment
- Active localized or systemic infection other than actinic keratosis lesions
- Any dermatological condition in treated areas judged inappropriate by the investigator
- Any current or past skin condition deemed inappropriate for study participation by the investigator
- Significant medical conditions judged inappropriate for participation by the investigator
- Known allergy or hypersensitivity to ingredients in cosmetic products used in the study
- Participation in another clinical study 30 days before first visit and 30 days after last visit
- Use of light-based devices like PUVA, IPL, laser, LED, or tanning beds within 4 weeks before enrollment
- Applied any topical product on investigational areas on enrollment day
- Under legal guardianship or incapacitation
- Psychologically incapable of signing informed consent or unable to comply with study requirements per investigator judgment
AI-Screening
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Trial Site Locations
Total: 1 location
1
Sydney Melanoma Diagnostic Centre, Royal Prince Alfred Hospital
Camperdown, New South Wales, Australia, 2050
Actively Recruiting
Research Team
P
Pascale GUITERA, MD, Derm
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
PREVENTION
Number of Arms
2
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