Sydney Melanoma Diagnostic Centre, Royal Prince Alfred Hospital
Camperdown, New South Wales, 2050, Australia
Location status: Recruiting
NCT Number: NCT07335003
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.
Interested in participating?
Request Info60 year and older
All sexes
Interventional
Not applicable
Camperdown, New South Wales, 2050, Australia
Location status: Recruiting
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
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.
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).
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)
Time frame: at baseline, 3, 6 and 9 months post commencement of intervention
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.
Time frame: at baseline, 3, 6 and 9 months post-commencement of intervention
Line-Field Optical Coherence Tomography (LC-OCT) images will be acquired on 2 Actinic Keratosis lesions.
Measured metric: Thickness of layers (in µm)
Time frame: at baseline and 6 months post-commencement of intervention
using skin biopsy (for morphology, immunohistochemistry) in a subset of participants (10 patients per group)
Time frame: 6 months post-commencement of intervention
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)
Time frame: at 1, 2, 3, 6 and 9 months post-commencement of intervention
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.
Time frame: at baseline, 3, 6 and 9 months post-commencement of intervention
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)
Time frame: at baseline, 3, 6 and 9 months post-commencement of intervention
Line-Field Optical Coherence Tomography (LC-OCT) images will be acquired on 2 Actinic Keratosis lesions.
Measured metric: Dermal-Epidermal Junction undulation score (in %)
Time frame: at baseline, 3, 6 and 9 months post-commencement of intervention
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)
Time frame: at baseline, 3, 6 and 9 months post-commencement of intervention
Line-Field Optical Coherence Tomography (LC-OCT) images will be acquired on 2 Actinic Keratosis lesions.
Measured metric: morphological characterization (volume, compactness)
Time frame: at baseline, 3, 6 and 9 months post-commencement of intervention
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)
Contact information is provided by the study sponsor or research team.
Cosmetique Active International
Industry
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
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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