PsoriasisCERAMOL PSOR CNCT07849101
Ceramol PSOR Cream as an Adjuvant Treatment in Patients With Mild-to-Moderate Psoriasis Treated With Narrowband UVB Phototherapy (CERAMOL PSOR CREMA)
A study testing Narrowband UVB Phototherapy, Ceramol PSOR Cream and Comparator Emollient Cream in people with Psoriasis and Psoriasis; Plaque, run by Unifarco SpA at 3 sites in Spain.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Psoriasis, Psoriasis; Plaque, Psoriasis Vulgaris
- What is being tested?
- Narrowband UVB Phototherapy, Ceramol PSOR Cream and Comparator Emollient Cream
- Type of treatment
- Medical device, Surgery or procedure
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 128 participants
- Where
- 3 sitesSpain
- Study dates
- Oct 2026to Jun 2027
- Phase
- Interventional
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
3 sites in 1 country. Contact the study team or a site near you to ask about taking part.
Spain3 sites
Hospital Universitario de La Princesa
Madrid, Madrid, 28006
Mar Llamas Velasco, MD
Hospital Universitario 12 de Octubre
Madrid, Madrid, 28041
Raquel Rivera Díaz, MD
Hospital Universitario Puerta de Hierro Majadahonda
Madrid, Madrid, 28222
Mercedes Hospital Gil, MD
About this study
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
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.
Read the detailed description
Psoriasis is a chronic, immune-mediated inflammatory skin disease frequently associated with impaired skin barrier function, dryness, pruritus, and reduced quality of life. Narrowband UVB phototherapy is a standard-of-care treatment for mild-to-moderate plaque psoriasis, but it can further compromise skin barrier integrity and hydration. Emollients containing ceramides, cholesterol, fatty acids and urea have been reported to support barrier repair, reduce transepidermal water loss, and improve tolerance to phototherapy when used as adjuvant treatments.
Ceramol PSOR cream is a CE-marked (Class IIa) medical device manufactured by Unifarco S.p.A., formulated with ceramides, cholesterol, fatty acids and urea, indicated for the hyperkeratotic and scaly forms of mild and/or moderate psoriasis. Participants will be randomized 1:1 to receive either Ceramol PSOR cream or a cosmetically similar comparator emollient cream lacking the specific functional ingredients, applied topically once daily as an adjuvant to their narrowband UVB phototherapy cycle.
The study includes three in-person visits: a baseline visit (V1, day 0, including informed consent, eligibility confirmation, and randomization), a follow-up visit (V2, after 12 ± 3 UVB sessions) and an end-of-study visit (V3, after 36 ± 3 UVB sessions). A sample size of 128 participants (allowing ~10% loss to follow-up) will be recruited across 4 sites in Spain.
- Conditions
- Psoriasis, Psoriasis; Plaque, Psoriasis Vulgaris
- Being tested
- Narrowband UVB Phototherapy, Ceramol PSOR Cream, Comparator Emollient Cream
- Keywords
- Psoriasis, Narrowband UVB phototherapy, Adjuvant treatment, Emollient, Quality of life
- Medical subject headings
- Psoriasis, Plaque, Amyloid
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Narrowband UVB PhototherapyRadiation
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 CreamDevice
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 CreamOther
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 group | Role | What they receive |
|---|---|---|
| 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). Receives: 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). Receives: Radiation: Narrowband UVB Phototherapy; Other: Comparator Emollient Cream |
What is being measured
The primary outcome is the main question the study is designed to answer.
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:
- an absolute PASI score ≤ 3 assessed at the end-of-study visit (V3), AND
- 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).
Measured: 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)
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).
Measured: 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)
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).
Measured: 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)
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).
Measured: Baseline (D0) to Visit 2 (approx. weeks 3-5)
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).
Measured: Baseline (D0) to Visit 3 (approx. weeks 11-18)
Change in dryness/tightness Visual Analogue Scale (VAS) score (baseline to Visit 2)
Change in the dryness/tightness Visual Analogue Scale (VAS) score from baseline to the follow-up visit (V2). The dryness/tightness VAS ranges from 0 to 10, with higher scores indicating greater dryness/tightness severity (worse outcome).
Measured: Baseline (D0) to Visit 2 (approx. weeks 3-5)
Change in dryness/tightness Visual Analogue Scale (VAS) score (baseline to end of study)
Change in the dryness/tightness Visual Analogue Scale (VAS) score from baseline to the end-of-study visit (V3). The dryness/tightness VAS ranges from 0 to 10, with higher scores indicating greater dryness/tightness severity (worse outcome).
Measured: Baseline (D0) to Visit 3 (approx. weeks 11-18)
Proportion with clinically relevant pruritus improvement (baseline to Visit 2)
Proportion of participants with a clinically relevant improvement, defined as a reduction ≥ 2 points on the pruritus Visual Analogue Scale (VAS) (0-10), from baseline to the follow-up visit (V2).
Measured: Baseline (D0) to Visit 2 (approx. weeks 3-5)
Proportion with clinically relevant pruritus improvement (baseline to end of study)
Proportion of participants with a clinically relevant improvement, defined as a reduction ≥ 2 points on the pruritus/itching Visual Analogue Scale (VAS) (0-10), from baseline to the end-of-study visit (V3).
Measured: Baseline (D0) to Visit 3 (approx. weeks 11-18)
Change in quality of life (Dermatology Life Quality Index - DLQI)
Change in the Dermatology Life Quality Index (DLQI) score from the baseline visit to the end-of-study visit (V3). The DLQI ranges from 0 to 30, with higher scores indicating greater impairment of quality of life (worse outcome).
Measured: Baseline (D0) to Visit 3 (approx. weeks 11-18)
Treatment satisfaction
Participant-reported satisfaction with the treatment received, measured with the Treatment Satisfaction Visual Analogue Scale (VAS) at the end-of-study visit (V3). The Treatment Satisfaction VAS ranges from 0 to 10, with higher scores indicating greater treatment satisfaction (better outcome).
Measured: Visit 3, after 36 ± 3 UVB sessions (approx. weeks 11-18)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Sep 2026
- Study startOct 2026 (estimated)
- Primary completionJun 2027 (estimated)
- Study completionJun 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for PsoriasisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 128 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Unifarco SpA
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Raquel Rivera Díaz, MD, Principal investigator, Hospital Universitario 12 de Octubre
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07849101
- Sponsor's protocol ID
- ES-PSOR-CR-001
- Acronym
- CERAMOL PSOR C
- Status last verified
- Sep 2026
- First submitted
- 17 Sep 2026
- Last updated
- 30 Sep 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: De-identified IPD that underlies the results reported in the publication will be shared after publication of primary results upon request of investigators whose proposed research has received IRB approval and after a data sharing agreement.