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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
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| 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 |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Tested product group | Other | 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. |
| 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 |
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Pascale GUITERA, MD, Derm | Contact | +61 02 9515 8537 | pascale@guitera.com |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Sydney Melanoma Diagnostic Centre, Royal Prince Alfred Hospital | Recruiting | Camperdown | New South Wales | 2050 | Australia |
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| Control group | Other | 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). |
|
| 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 |
| ID | Term |
|---|---|
| D055623 | Keratosis, Actinic |
| D004194 | Disease |
| ID | Term |
|---|---|
| D011230 | Precancerous Conditions |
| D009369 | Neoplasms |
| D007642 | Keratosis |
| D012871 | Skin Diseases |
| D017437 | Skin and Connective Tissue Diseases |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
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| ID | Term |
|---|---|
| D035061 | Control Groups |
| ID | Term |
|---|---|
| D015340 | Epidemiologic Research Design |
| D004812 | Epidemiologic Methods |
| D008919 | Investigative Techniques |
| D012107 | Research Design |
| D008722 | Methods |
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