Premalignant AKs are highly frequent in the light-skinned populations with an increasing incidence. PDT is considered a well-establish treatment for these lesions, and therefore it is essential to achieve an optimal and effective treatment as possible. The present study proposes a new post-treatment modality with application of an anti-inflammatory moisturizer Cicaplast Baume B5+ to the treated areas that may improve the overall patient satisfaction and minimize the local skin reactions. Treatment regime consists of two daily applications of Cicaplast Baume B5+ for 14 days, and this regime is not associated with increased risk of systemic AEs or serious events.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
20
Immediately after daylight PDT, Cicaplast is administrated as post treatment. The patients are instructed to apply the cream twice daily for 14 days.
Daylight PDT performed with 2 hours of artifical indoor light.
Bispebjerg Hospital
Copenhagen NV, Denmark
Changes in clinically assessed local skin responses after PDT in Cicaplast Baume B5+ treated skin vs. non-post-treated skin from baseline to day 30
Clinical evaluation of erythema, edema, and crusting will be done in the two treatment areas at all visits and scored on a four-point scale (0-3): None, mild, moderate, or severe
Time frame: From baseline to day 30
Evaluation of AK identification and grading before PDT and following PDT treatment in skin treated with Cicaplast Baume B5+ treated skin vs. non-post-treated skin
Evaluation of clinical response including AK identification and grading will be performed by trained physicians at baseline and at follow-up visits. AK identification and grading will be performed according to Olsen grade classification system: * Grade I: Flat, pink maculae without signs of hyperkeratosis and erythema often easier felt than seen * Grade II: Moderately thick hyperkeratosis on background of erythema that easily felt and seen * Grade III: Very thick hyperkeratosis Occurrence of new AKs in the treatment areas will be recorded at day 30 using the baseline template. The number and severity of the new lesion in the treatment areas will be recorded.
Time frame: Evaluated at baseline and at day 30
Changes in local skin responses after PDT in Cicaplast Baume B5+ treated skin vs. non-post-treated skin
OCT system will be used to visualize the epidemis and upper dermis and changes in the cutanous microvascular morphology. All images will be evaluated qualitatively and quantitively using the integrated OCT software.
Time frame: From baseline to day 30
changes in the skin barrier function from baseline to day 30
Skin barrier function is assessed by measurements of trans-epidermal water loss (TEWL) with DermaLab, Cortex Technology, Hadsund, Denmark. Patients will be adjusted to room temperature before TEWL measurements, and skin pH will be measured using a pH-meter from DermaLab, Cortex Technology, Hadsund, Denmark. All measurements will be performed in triplicates and median value will be calculated.
Time frame: from baseline to day 30
Changes in pigmentation and redness of the skin from baseline to day 30
The level of erythema and melanin will be estimated at the treatment areas in the face or the décolleté using the CE-marked Skin Colormeter DSM. In addition, erythema and melanin will be estimated in the face using the VISIA, Canfield imaging system, Fairfield, NJ, USA. VISIA uses standard incandescent light, ultraviolet (UV) and cross-polarized light, and generates a series of high-resolution images to determine the patient's overall skin condition. The images will be analyzed with Canfield's software RBX Technology.
Time frame: From baseline to day 30
Pain during PDT treatment
Will be evaluated by the patient on a numerical scale 0-10: 0 = none, 10 = worst imaginable pain
Time frame: During the procedure
Pain in the treatment areas
Pain will be evaluated by the patient from day 1 to day 30 by completing a diary with information on pain in the Cicaplast Baume B5+ treated area vs. the non-post-treated area . The scale 0-10: 0 = none, 10 = worst imaginable pain will be used.
Time frame: from day 1 to day 30
Incidence of prutitus in the treatment areas from day 1 to day 30
Patients will be asked to evaluate the incidence of prutitus in Cicaplast Baume B5+ treated area and the non-post-treated area. Pruritus will be evaluted on the scale 0-3: 0 = none, 1 = light, 2 = moderate, 3 = severe
Time frame: from day 1 to day 30
Patients satisfaction with the treatment of daylight PDT + Cicaplast Baume B5+ compared to daylight PDT alone
Patients will be asked to evaluate their satisfaction with the treatment on a scale 0-10: 0 = could not be more unsatisfied, 10 = could not be more satisfied
Time frame: from baseline to day 30
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