Actinic Keratosis Clinical Trials

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Prospective Randomized Controlled Study of the Photoprotection and Prevention of Actinic Damage With Anthelios Fluide 100 KA+ UVMune 400 in Patients With Multiple Actinic Keratoses

Status: Recruiting
Location: See location...
Intervention Type: Other
Study Type: Interventional
Study Phase: Not Applicable
SUMMARY

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.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 60
Healthy Volunteers: f
View:

• 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.

Locations
Other Locations
Australia
Sydney Melanoma Diagnostic Centre, Royal Prince Alfred Hospital
RECRUITING
Camperdown
Contact Information
Primary
Pascale GUITERA, MD, Derm
pascale@guitera.com
+61 02 9515 8537
Time Frame
Start Date: 2025-07-01
Estimated Completion Date: 2029-03
Participants
Target number of participants: 80
Treatments
Active_comparator: Sunscreen investigational product
Participants (40) will be asked to follow usual recommendations for AK patients as per sun protection information guidelines document provided by Melanoma Institute Australia and will use the sunscreen investigational product at least once every morning and to reapply as often as necessary during the day in case of sun exposure.
Placebo_comparator: Control Group
Participants (40) will be asked to follow usual recommendations for AK patients as per sun protection information guidelines document provided by Melanoma Institute Australia and may use their normal sun cream
Related Therapeutic Areas
Sponsors
Leads: Cosmetique Active International

This content was sourced from clinicaltrials.gov