Actively Recruiting
Study of Photoprotection Using Anthelios Fluide 100 KA+ UVMune 400 for Preventing Actinic Damage in Patients With Multiple Actinic Keratoses
Led by Cosmetique Active International · Updated on 2026-01-12
80
Participants Needed
1
Research Sites
N/A
Total Duration
On this page
AI-Summary
What this Trial Is About
This research aims to study the protective effect of an investigational sunscreen called Anthelios Fluide 100 KA+ UVMune 400 on people diagnosed with multiple actinic keratosis lesions (AK). AK lesions are small, rough, dry, scaly patches or bumps on the skin that can be skin-colored, pink, red, or tan and are often easier to feel than see in early stages. These lesions are common in adults, especially those aged 45 and older, and are considered pre-cancerous. Participants will be randomly assigned to one of two groups: the intervention group will use the investigational sunscreen daily, applying it at least once every morning and reapplying during sun exposure, while following good sun protection habits such as seeking shade, wearing protective clothing, and hats. The control group will follow usual sun protection recommendations and may use their preferred broad-spectrum sunscreen with SPF 50+ as usual. The study will observe participants over 9 months. During the study, researchers will assess the number of actinic keratosis lesions at the start and at 3, 6, and 9 months. Other evaluations include skin thickness, disease severity biomarkers, and participant self-assessments. Safety will be monitored by adverse event reports throughout the study. Participants will follow specific sun protection guidelines and apply the sunscreen as directed while researchers track changes in their skin condition and overall photoprotection.
CONDITIONS
Brief 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...
- Adult outpatients aged 60 years or older
- At least 11 clinically typical actinic keratosis lesions, including at least one on the face
- Ability 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 two squamous cell carcinomas
- Known immune system suppression in the past year
- Inability to undergo skin biopsies or history of scarring or adverse effects from local anesthesia
- Use of interferon, immunomodulators, cytotoxic or immunosuppressive drugs, corticosteroids, retinoids, keratolytics, or investigational drugs within 4 weeks before enrollment
- Active localized or systemic infections other than actinic keratosis lesions
- Dermatological conditions in treated or adjacent areas judged inappropriate by investigator
- Past or present skin conditions or medical issues deemed unsuitable for participation
- Known allergies or hypersensitivity to ingredients in cosmetic products
- Participation in another clinical trial 30 days before and after this study
- Use of light-based therapies or tanning beds within 4 weeks before enrollment
- Application of topical products on investigational areas on enrollment day
- Under legal guardianship or incapacitated
- Psychological incapacity to provide informed consent or comply with the protocol according to investigator judgment
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - 9 months
Participants apply the assigned sunscreen daily to exposed skin areas to prevent actinic damage. The investigational group applies the investigational sunscreen every morning and re-applies as needed during sun exposure. The control group uses their preferred sunscreen as usual.
Visits at baseline, 1, 2, 3, 6, and 9 months post commencement
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
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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