Ireland
--:--IST
Latest
Astellas Expands Its 330 Million Euro Tralee Biopharma Facility with a Second Aseptic Filling Line to Double Drug-Product Capacity Xeolas Pharmaceuticals Opens 158,000 Sq Ft State-of-the-Art Baldoyle Facility to Scale Specialty Medicine Manufacturing Priya Life Science Partners with Fleming for the 9th Annual Corporate Compliance & Transparency in Life Sciences Summit in Zurich Ireland Has the Capital and the Lessons: Digital Project Management Is How They Become Delivery Dunbar Pharma Brings First Plant-Derived Dronabinol API to UK Market Through IPS Pharma Leveraging Priya Life Science as a Data Tracker: The Ultimate Use Case & Career Guide The €100K Reality Check: Why a Six-Figure Pharma Salary in Ireland Feels Different Than in Switzerland or Germany Ireland's €93.8 Billion Non-EU Pharma Export Engine: Trade Data, Destination Markets, and Economic Impact Astellas Expands Its 330 Million Euro Tralee Biopharma Facility with a Second Aseptic Filling Line to Double Drug-Product Capacity Xeolas Pharmaceuticals Opens 158,000 Sq Ft State-of-the-Art Baldoyle Facility to Scale Specialty Medicine Manufacturing Priya Life Science Partners with Fleming for the 9th Annual Corporate Compliance & Transparency in Life Sciences Summit in Zurich Ireland Has the Capital and the Lessons: Digital Project Management Is How They Become Delivery Dunbar Pharma Brings First Plant-Derived Dronabinol API to UK Market Through IPS Pharma Leveraging Priya Life Science as a Data Tracker: The Ultimate Use Case & Career Guide The €100K Reality Check: Why a Six-Figure Pharma Salary in Ireland Feels Different Than in Switzerland or Germany Ireland's €93.8 Billion Non-EU Pharma Export Engine: Trade Data, Destination Markets, and Economic Impact
Recruiting Not applicable

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

NCT07335003 · tracked via the Priya Life Science Australia tracker
Sponsor
Cosmetique Active International
Phase
Not applicable
Started
2025-07-01
Last updated
2026-01-12

Condition(s) studied

Actinic Keratosis (AK)

Investigational drug(s) / intervention(s)

Tested product groupControl group

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.

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).

Study 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

Sex
ALL
Min age
60 Years
Max age
—
Healthy volunteers
No
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.

Primary outcome measure(s)

  • The full body number of Actinic Keratosis lesions — at baseline, 3, 6 and 9 months post commencement of intervention
    Actinic Keratosis clinical evaluation (total number of lesions and severity and location will be recorded)

Trial sites (1)

FacilityCityRegionStatus
Sydney Melanoma Diagnostic Centre, Royal Prince Alfred Hospital Camperdown New South Wales Recruiting
Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT07335003 on ClinicalTrials.gov ↗ ← All trials in Australia