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

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.

Study Overview

• Status: Recruiting
• Conditions: Actinic Keratosis (AK)
• Intervention / Treatment: Other: Tested product group; Other: Control group

• Study Type: Interventional
• Enrollment (Estimated): 80
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Pascale GUITERA, MD, Derm; Phone Number: +61 02 9515 8537; Email: pascale@guitera.com

Study Locations

• Australia
  • New South Wales
    • Camperdown, New South Wales, Australia, 2050
      • Recruiting
      • Sydney Melanoma Diagnostic Centre, Royal Prince Alfred Hospital
      • Contact: Pascale GUITERA, MD, Derm; Phone Number: +61 02 9515 8537; Email: pascale.guitera@melanoma.org.au

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
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.	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.
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	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).

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Variation of the photoprotection index (SEPI) - questionnaire	Scoring instrument for assessments of sun habits and sun protection behaviour. It consists of 2 parts: part I addressing the present behaviour and part II addressing propensity to increase sun protection based on the Transtheorical Model of Behaviour Change.	at baseline, 3, 6 and 9 months post commencement of intervention
Variation of layers' thickness on Actinic Keratosis lesions	Line-Field Optical Coherence Tomography (LC-OCT) images will be acquired on 2 Actinic Keratosis lesions. Measured metric: Thickness of layers (in µm)	at baseline, 3, 6 and 9 months post-commencement of intervention
Variation of biomarkers of disease severity (p53)	using skin biopsy (for morphology, immunohistochemistry) in a subset of participants (10 patients per group)	at baseline and 6 months post-commencement of intervention
Questionnaire (self-assessment)	Questions on cosmeticity, efficacy and tolerability of the investigational product tested will be completed by patients. 5 different responses will be proposed (Disagree, Disagree partly, Neither agree neither disagree, Agree and Fully agree)	6 months post-commencement of intervention
Adverse Events reporting	Any untoward medical occurrence, unintended disease or injury or any untoward clinical signs in patients, users or other persons whether or not related to the investigational product or procedures.	at 1, 2, 3, 6 and 9 months post-commencement of intervention
Variation of protusion on Actinic Keratosis lesions	Line-Field Optical Coherence Tomography (LC-OCT) images will be acquired on 2 Actinic Keratosis lesions. Measured metric: Protrusion score (grade 1, 2 and 3)	at baseline, 3, 6 and 9 months post-commencement of intervention
Variation of DEJ undulation on Actinic Keratosis lesions	Line-Field Optical Coherence Tomography (LC-OCT) images will be acquired on 2 Actinic Keratosis lesions. Measured metric: Dermal-Epidermal Junction undulation score (in %)	at baseline, 3, 6 and 9 months post-commencement of intervention
Variation of Keratinocyte nucleus atypia on Actinic Keratosis lesions	Line-Field Optical Coherence Tomography (LC-OCT) images will be acquired on 2 Actinic Keratosis lesions. Measured metric: Keratinocyte nucleus atypia score (value between 0 and 1)	at baseline, 3, 6 and 9 months post-commencement of intervention
Variation of Keratinocyte nucleus morphological characterization on Actinic Keratosis lesions	Line-Field Optical Coherence Tomography (LC-OCT) images will be acquired on 2 Actinic Keratosis lesions. Measured metric: morphological characterization (volume, compactness)	at baseline, 3, 6 and 9 months post-commencement of intervention
Variation of Keratinocyte nucleus distribution on Actinic Keratosis lesions	Line-Field Optical Coherence Tomography (LC-OCT) images will be acquired on 2 Actinic Keratosis lesions. Measured metric: Keratinocyte nucleus distribution (density, distribution by layer)	at baseline, 3, 6 and 9 months post-commencement of intervention

Collaborators and Investigators

• Sponsor: Cosmetique Active International

Study record dates

Study Major Dates

• Study Start (Actual): July 1, 2025
• Primary Completion (Estimated): March 1, 2029
• Study Completion (Estimated): March 1, 2029

Study Registration Dates

• First Submitted: July 4, 2025
• First Submitted That Met QC Criteria: January 6, 2026
• First Posted (Estimated): January 12, 2026

Study Record Updates

• Last Update Posted (Estimated): January 12, 2026
• Last Update Submitted That Met QC Criteria: January 6, 2026
• Last Verified: January 1, 2026

More Information

Terms related to this study

• Keywords: Prevention; diagnosis; actinic keratosis; Photoprotection
• Additional Relevant MeSH Terms: Pathologic Processes; Neoplasms; Skin Diseases; Precancerous Conditions; Keratosis; Pathological Conditions, Signs and Symptoms; Skin and Connective Tissue Diseases; Disease; Keratosis, Actinic; Investigative Techniques; Epidemiologic Research Design; Epidemiologic Methods; Research Design; Methods; Control Groups
• Other Study ID Numbers: X24-0147 / LRP23028

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No