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

NCT07849101 | Not Yet Recruiting

• 1 other identifier: ES-PSOR-CR-001
• Study Type: interventional
• Target: 128
• Locations: 1 country
• Sites: 3

Brief 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.

Conditions

Psoriasis; Psoriasis; Plaque; Psoriasis Vulgaris

Keywords

Psoriasis; Narrowband UVB phototherapy; Adjuvant treatment; Emollient; Quality of life

Outcome Measures

Primary Outcomes (1)

• 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).

  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).

Secondary Outcomes (10)

• Change in Psoriasis Area and Severity Index (PASI) score (baseline to Visit 2)

  Baseline (D0) to Visit 2, after 12 ± 3 UVB sessions (approx. weeks 3-5)

• Change in Psoriasis Area and Severity Index (PASI) score (baseline to end of study)

  Baseline (D0) to Visit 3, after 36 ± 3 UVB sessions (approx. weeks 11-18)

• Change in pruritus/itching Visual Analogue Scale (VAS) score (baseline to Visit 2)

  Baseline (D0) to Visit 2 (approx. weeks 3-5)

• Change in pruritus/itching Visual Analogue Scale (VAS) score (baseline to end of study)

  Baseline (D0) to Visit 3 (approx. weeks 11-18)

• Change in dryness/tightness Visual Analogue Scale (VAS) score (baseline to Visit 2)

  Baseline (D0) to Visit 2 (approx. weeks 3-5)

Study Arms (2)

Ceramol PSOR cream group - Device: Ceramol PSOR Cream

EXPERIMENTAL

Topical application of Ceramol PSOR cream once daily as an adjuvant to narrowband UVB phototherapy, throughout one phototherapy cycle (36 ± 3 sessions).

Radiation: Narrowband UVB Phototherapy; Device: Ceramol PSOR Cream

Comparator emollient cream group

PLACEBO COMPARATOR

Topical application of a cosmetically similar comparator emollient cream, without the specific functional ingredients (ceramides, cholesterol, fatty acids, urea) present in Ceramol PSOR cream, once daily as an adjuvant to narrowband UVB phototherapy, throughout one phototherapy cycle (36 ± 3 sessions).

Radiation: Narrowband UVB Phototherapy; Other: Comparator Emollient Cream

Interventions

Ceramol PSOR Cream DEVICE

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).

Ceramol PSOR cream group - Device: Ceramol PSOR Cream

Comparator Emollient Cream OTHER

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).

Comparator emollient cream group

Narrowband UVB Phototherapy RADIATION

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 group - Device: Ceramol PSOR Cream; Comparator emollient cream group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.
• Presence of at least one psoriasis-associated symptom (pruritus/burning, dryness/tightness) with a VAS score ≥ 3 at study entry.
• Ability to understand and sign the Informed Consent Form
• Willingness to use only the study product as the daily body moisturizer during the phototherapy cycle.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Unifarco SpA: lead

Study Sites (3)

Hospital Universitario de La Princesa

Madrid, Madrid, 28006, Spain

Location

Hospital Universitario 12 de Octubre

Madrid, Madrid, 28041, Spain

Location

Hospital Universitario Puerta de Hierro Majadahonda

Madrid, Madrid, 28222, Spain

Location

MeSH Terms

Conditions

Psoriasis; Plaque, Amyloid

Condition Hierarchy (Ancestors)

Skin Diseases, Papulosquamous; Skin Diseases; Skin and Connective Tissue Diseases; Pathological Conditions, Anatomical; Pathological Conditions, Signs and Symptoms

Study Officials

• Raquel Rivera Díaz, MD

  Hospital Universitario 12 de Octubre

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Daniel Fernández-Villa, PhD

CONTACT

(+34) 91 779 26 37; danielfvilla.imas12@h12o.es

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 17, 2026
• First Posted: September 30, 2026
• Study Start: October 1, 2026
• Primary Completion (Estimated): June 1, 2027
• Study Completion (Estimated): June 1, 2027
• Last Updated: September 30, 2026

Record last verified: 2026-09

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL
• Time Frame: From the time of publication and for 5 years thereafter.
• Access Criteria: Upon request of investigators whose proposed research has received IRB approval and after a data sharing agreement.

Locations

ES (3)