NCT07335003

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

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
• Phase: N/A
• Study type: Interventional
• Enrollment: 80 (estimated)
• Sponsor: Cosmetique Active International · Industry
• Sex: All
• Age: 60 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Actinic Keratosis (AK)

Interventions

Type	Name	Description
OTHER	Tested product group	The investigational sunscreen will be applied at least once every morning. Product will be re-applied every 2 hours in case of prolonged exposure or when the likelihood of sunscreen having been removed is high, such as after sweating, water immersion, friction from clothing and exfoliation from sand. The investigational product should be applied on all exposed areas. Scalp, face (avoiding eye contours), neck, forearms, back of the hands, and décolleté will be treated every day . The recommended application dose is 2 mg/cm².
OTHER	Control group	Participants will be allowed to use the preferred sunscreen (a broad spectrum sunscreen with an SPF of at least 50+) as per their usual routine (every 2 hours and after swimming or exercice).

Timeline

• Start date: 2025-07-01
• Primary completion: 2029-03-01
• Completion: 2029-03-01
• First posted: 2026-01-12
• Last updated: 2026-01-12

Locations

1 site across 1 country: Australia