PROXERA PSOMED 20 and 40 Clinical Study for Plaque and Palmoplantar Psoriasis
Summary
NIH has registered a single-center interventional clinical study (NCT07545902) evaluating the efficacy and safety of PROXERA PSOMED 20 cream for non-palmoplantar plaque psoriasis and PROXERA PSOMED 40 gel for non-pustular palmoplantar psoriasis. Both are CE-marked topical medical devices. The study uses an untreated contralateral control design with primary assessments at 4 weeks (PSOMED 20) and 8 weeks (PSOMED 40). Secondary endpoints include safety, tolerability, quality of life, and local disease activity.
“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.”
About this source
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What changed
NIH has registered a new clinical trial on ClinicalTrials.gov for two CE-marked topical medical devices—PROXERA PSOMED 20 (cream) and PROXERA PSOMED 40 (gel)—used in the treatment of plaque psoriasis and non-pustular palmoplantar psoriasis, respectively. The single-center study uses an intra-individual controlled design, treating a target lesion on one side while using the untreated contralateral side as a control. Participants will apply the assigned device once daily.
Manufacturers of CE-marked dermatological medical devices, clinical investigators, and institutional review boards should note this registry entry when assessing comparable device studies. The trial is registered under NCT07545902 with a primary assessment endpoint of April 22, 2026.
Archived snapshot
Apr 23, 2026GovPing captured this document from the original source. If the source has since changed or been removed, this is the text as it existed at that time.
Clinical Study on the Medical Devices PROXERA PSOMED 20 and PROXERA PSOMED 40 for the Treatment of Plaque Psoriasis and Non-pustular Palmoplantar Psoriasis
N/A NCT07545902 Kind: NA Apr 22, 2026
Abstract
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: PROXERA PSOMED 20 cream; PROXERA PSOMED 40 gel
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