Ceramol PSOR Cream as an Adjuvant Treatment in Patients With Mild-to-Moderate Psoriasis Treated With Narrowband UVB Phototherapy (CERAMOL PSOR CREMA)

Condition(s) studied

Investigational drug(s) / intervention(s)

Narrowband UVB Phototherapy: Standard-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: CE-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: Cosmetic 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).

Study summary

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.

Eligibility

Primary outcome measure(s)

• Proportion of participants achieving a combined clinical and symptomatic response — PASI component: end-of-study visit (V3). Pruritus VAS component: change from baseline (V1) to end-of-study visit (V3). V3 occurs after 36 ± 3 UVB sessions (approximately weeks 11-18).
  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).

Trial sites (3)

Other trials for the same condition