Clinical Research Directory
Browse clinical research sites, groups, and studies.
Ceramol PSOR Cream as an Adjuvant Treatment in Patients With Mild-to-Moderate Psoriasis Treated With Narrowband UVB Phototherapy (CERAMOL PSOR CREMA)
Sponsor: Unifarco SpA
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.
Official title: Multicenter, Prospective, Randomized, Open-Label, Controlled, Two-Arm, Parallel-Group, Superiority Clinical Investigation on the Use of Ceramol PSOR Cream in Patients With Mild-to-Moderate Plaque Psoriasis Treated With Narrowband UVB Phototherapy: CERAMOL PSOR CREMA Study
Key Details
Gender
All
Age Range
18 Years - Any
Study Type
INTERVENTIONAL
Enrollment
128
Start Date
2026-10
Completion Date
2027-06
Last Updated
2026-09-30
Healthy Volunteers
No
Interventions
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).
Locations (3)
Hospital Universitario de La Princesa
Madrid, Madrid, Spain
Hospital Universitario 12 de Octubre
Madrid, Madrid, Spain
Hospital Universitario Puerta de Hierro Majadahonda
Madrid, Madrid, Spain