Actinic Keratosis (AK)NCT07335003
Study of the Photoprotection and Prevention of Actinic Damage With Anthelios Fluide 100 KA+ UVMune 400 in Patients With Multiple Actinic Keratoses
A study testing Tested product group in people with Actinic Keratosis (AK), run by Cosmetique Active International at 1 site in Australia.
Trial 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… Read more about this study
- Who is it for?
- Ages 60 years and older
- Conditions the study is for
- Actinic Keratosis (AK)
- What is being tested?
- Tested product group
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 80 participants
- Where
- 1 siteAustralia
- Study dates
- 1 Jul 2025to Mar 2029
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 60 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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);
- History of >2 squamous cell carcinomas;
- Known history of immunodepression whatever its cause in the past year;
- 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.
- 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
- Participant having active, localized or systemic infection other than the AK lesions
Show all 15Show fewer
- Participant having any dermatological affection within the treated and adjacent area according to the Investigator judgement
- Participant having a present or past skin condition that according to Investigator judgment, deems inappropriate for study participation
- Participant having other significant medical conditions that according to Investigator Judgment, deems inappropriate for study participation
- Participant having a known hypersensitivity, allergy or contraindication to any ingredients contained within the cosmetic products,
- 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
- 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.
- Participant having applied any topical product on the investigational areas the day of enrolment visit,
- Participant under legal guardianship or incapacitation.
- Participant being psychologically incapable of signing informed Consent Form and unable to comply with the protocol requirements according to investigator judgment.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Australia1 site, 1 recruiting
- Recruiting
Sydney Melanoma Diagnostic Centre, Royal Prince Alfred Hospital
Camperdown, New South Wales, 2050
Pascale GUITERA, MD, Derm, +61 02 9515 8537, pascale.guitera@melanoma.org.au
About this study
Official title: 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.
- Conditions
- Actinic Keratosis (AK)
- Being tested
- Tested product group, Control group
- Keywords
- Prevention, Photoprotection, actinic keratosis, diagnosis
- Medical subject headings
- Keratosis, Actinic, Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Tested product groupOther
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 groupOther
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 group | Role | What they receive |
|---|---|---|
| Sunscreen investigational product | Active comparator | 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. Receives: Other: Tested product group |
| Control Group | Placebo comparator | 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 Receives: Other: Control group |
What is being measured
The primary outcome is the main question the study is designed to answer.
The full body number of Actinic Keratosis lesions
Actinic Keratosis clinical evaluation (total number of lesions and severity and location will be recorded)
Measured: at baseline, 3, 6 and 9 months post commencement of intervention
Secondary outcomes (10)
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.
Measured: 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)
Measured: 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)
Measured: 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)
Measured: 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.
Measured: 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)
Measured: 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 %)
Measured: 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)
Measured: 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)
Measured: 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)
Measured: at baseline, 3, 6 and 9 months post-commencement of intervention
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Jan 2026
- Study start1 Jul 2025
- Primary completionMar 2029 (estimated)
- Study completionMar 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Actinic Keratosis (AK)Studies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 80 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Cosmetique Active International
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07335003
- Sponsor's protocol ID
- X24-0147 / LRP23028
- Status last verified
- Jan 2026
- First submitted
- 4 Jul 2025
- Last updated
- 12 Jan 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 12 Jan 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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
- ClinicalTrials.gov ID
- NCT07335003
- Acronym / sponsor ID
- X24-0147 / LRP23028
- Conditions
- Actinic Keratosis (AK)
- Keywords
- Prevention, Photoprotection, actinic keratosis, diagnosis
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 80 participants (estimated)
- Lead sponsor
- Cosmetique Active InternationalIndustry (pharma, biotech, devices)
- Study start
- 1 Jul 2025 (actual)
- Primary completion
- Mar 2029 (estimated)
- Study completion
- Mar 2029 (estimated)
- First posted
- 12 Jan 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Sunscreen investigational product | Active comparator | Other: Tested product groupParticipants (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. |
| Control Group | Placebo comparator | Other: Control groupParticipants (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 |
Who may qualify
- Ages
- 60 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- 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.
Key exclusion criteria (15 listed)
- 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);
- History of >2 squamous cell carcinomas;
- Known history of immunodepression whatever its cause in the past year;
- 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.
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Tested product groupThe 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 | Sunscreen investigational product |
| Control groupParticipants 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). | Other | Control Group |
Primary outcome
The full body number of Actinic Keratosis lesions
Time frame: 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)
10 secondary outcomes
Variation of the photoprotection index (SEPI) - questionnaire
Time frame: at baseline, 3, 6 and 9 months post commencement of intervention
Variation of layers' thickness on Actinic Keratosis lesions
Time frame: at baseline, 3, 6 and 9 months post-commencement of intervention
Variation of biomarkers of disease severity (p53)
Time frame: at baseline and 6 months post-commencement of intervention
Questionnaire (self-assessment)
Time frame: 6 months post-commencement of intervention
Adverse Events reporting
Time frame: at 1, 2, 3, 6 and 9 months post-commencement of intervention
Variation of protusion on Actinic Keratosis lesions
Time frame: at baseline, 3, 6 and 9 months post-commencement of intervention
Variation of DEJ undulation on Actinic Keratosis lesions
Time frame: at baseline, 3, 6 and 9 months post-commencement of intervention
Variation of Keratinocyte nucleus atypia on Actinic Keratosis lesions
Time frame: at baseline, 3, 6 and 9 months post-commencement of intervention
Variation of Keratinocyte nucleus morphological characterization on Actinic Keratosis lesions
Time frame: at baseline, 3, 6 and 9 months post-commencement of intervention
Variation of Keratinocyte nucleus distribution on Actinic Keratosis lesions
Time frame: at baseline, 3, 6 and 9 months post-commencement of intervention
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Jan 2026.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Tested product group in people with Actinic Keratosis (AK), run by Cosmetique Active International at 1 site in Australia.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 15 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 12 Jan 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Australia. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Pascale GUITERA, MD, Derm (+61 02 9515 8537, pascale@guitera.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The full body number of Actinic Keratosis lesions (time frame: at baseline, 3, 6 and 9 months post commencement of intervention). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 Jan 2026.