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Clinical Study on the Medical Devices PROXERA PSOMED 20 and PROXERA PSOMED 40 for the Treatment of Plaque Psoriasis and Non-pustular Palmoplantar Psoriasis

NCT07545902 · Status: RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 35

Last updated 2026-07-28

No results posted yet for this study

Summary

This single-center interventional study was designed to evaluate the efficacy and safety of two CE-marked topical medical devices: PROXERA PSOMED 20 is being studied in participants with non-palmoplantar plaque psoriasis, while PROXERA PSOMED 40 is being studied in participants with non-pustular palmoplantar psoriasis.

The study aims to determine whether treating a target area with the assigned medical device leads to greater clinical improvement compared to the untreated contralateral control area in the same participant. For PROXERA PSOMED 20, the primary assessment is performed after 4 weeks of treatment. For PROXERA PSOMED 40, the primary assessment is performed after 8 weeks of treatment.

Secondary objectives include the assessment of safety, local tolerability, overall psoriasis progress, its impact on quality of life, and additional parameters of local disease activity at the target areas. Participants will apply the assigned study device once daily to the selected target area, undergo clinical assessments at scheduled visits, and provide safety and tolerability information throughout the study.

Conditions

  • Plaque Type Psorisis
  • Non-pustular Palmoplantar Psoriasis

Interventions

DEVICE

PROXERA PSOMED 20 cream; PROXERA PSOMED 40 gel

Proxera Psomed 20: Topical medical device in cream formulation containing 20% urea, supplied in a 200 mL tube. It is self-applied by the participant once daily at the same time of day to the selected target plaque for 4 weeks, according to the fingertip unit rule. The contralateral comparable target area remains untreated as control. Proxera Psomed 40: Topical medical device in gel formulation containing 40% urea, supplied in a 100 mL tube. It is self-applied by the participant once daily at the same time of day to the selected target palm or sole area for 8 weeks, according to the fingertip unit rule. Treatment is interrupted for 3 days every 14 days. The contralateral comparable target area remains untreated as control.

Sponsors & Collaborators

  • ICIM International S.r.l.

    lead INDUSTRY

Study Design

Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
65 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2026-04-30
Primary Completion
2026-11-25
Completion
2026-12-23

Countries

  • Italy

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07545902 on ClinicalTrials.gov