This is a multicenter, prospective, randomized, open-label, controlled clinical investigation to evaluate whether Ceramol PSOR cream, used as an adjuvant treatment, is superior to a comparator emollient cream in patients with mild-to-moderate plaque psoriasis undergoing narrowband UVB phototherapy. Participants apply the assigned cream topically once daily throughout one standard phototherapy cycle (36 ± 3 UVB sessions). The study assesses clinical response (PASI, body surface area), subjective symptoms (pruritus and dryness/tightness VAS), quality of life (DLQI), treatment satisfaction, and adherence to both the investigational product and phototherapy.
Age ≥ 18 years.
Clinical diagnosis of mild or moderate plaque psoriasis.
Body surface area (BSA) involvement of 3-10%, excluding palms and soles.
Planned treatment with narrowband UVB phototherapy as part of routine clinical practice.
Patients receiving systemic pharmacological treatment for psoriasis.
Patients receiving topical pharmacological treatment for psoriasis, or who discontinued such treatment less than one (1) week before enrollment.
Any active dermatological condition unrelated to psoriasis that could interfere with study results.
Cognitive impairment preventing completion of the study questionnaires.
Parallel
Narrowband UVB Phototherapy
RadiationStandard-of-care narrowband ultraviolet B phototherapy administered per routine clinical practice, one cycle of 36 ± 3 sessions, delivered to all participants regardless of randomized cream assignment.
Ceramol PSOR Cream
DeviceCE-marked (Class IIa) topical medical device formulated with ceramides, cholesterol, fatty acids and urea. Applied once daily to the whole body throughout one narrowband UVB phototherapy cycle (36 ± 3 sessions).
Comparator Emollient Cream
Other interventionCosmetic emollient cream, cosmetically similar to Ceramol PSOR cream but without ceramides, cholesterol, fatty acids or urea. Applied once daily to the whole body throughout one narrowband UVB phototherapy cycle (36 ± 3 sessions).
Proportion of participants achieving a combined clinical and symptomatic response
Proportion of participants achieving a combined response after one cycle of narrowband UVB phototherapy (36 ± 3 sessions), defined as: 1. an absolute PASI score ≤ 3 assessed at the end-of-study visit (V3), AND 2. a reduction ≥ 2 points on the pruritus VAS (0-10), calculated as the difference between the baseline visit (V1) and the end-of-study visit (V3).
Change in Psoriasis Area and Severity Index (PASI) score (baseline to Visit 2)
Change in the Psoriasis Area and Severity Index (PASI) score from the baseline visit to the follow-up visit (V2). The PASI ranges from 0 to 72, with higher scores indicating greater psoriasis severity (worse outcome).
Change in Psoriasis Area and Severity Index (PASI) score (baseline to end of study)
Change in the Psoriasis Area and Severity Index (PASI) score from the baseline visit to the end-of-study visit (V3). The PASI ranges from 0 to 72, with higher scores indicating greater psoriasis severity (worse outcome).
Change in pruritus/itching Visual Analogue Scale (VAS) score (baseline to Visit 2)
Change in the pruritus/itching Visual Analogue Scale (VAS) score from baseline to the follow-up visit (V2). The pruritus/itching VAS ranges from 0 to 10, with higher scores indicating greater itching intensity (worse outcome).
Change in pruritus/itching Visual Analogue Scale (VAS) score (baseline to end of study)
Change in the pruritus/itching Visual Analogue Scale (VAS) score from baseline to the end-of-study visit (V3). The pruritus/itching VAS ranges from 0 to 10, with higher scores indicating greater itching intensity (worse outcome).
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