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Active Not RecruitingNCT05185258

Residual Disease MEMory in PSOriasis Skin During EnstiLAR® and Narrow-band Ultraviolet B Therapy: The MEMPSOLAR Study

An Investigator-Initiated, Phase 4, Open-Label, Single-Arm, Single-Center Study Investigating the Residual Disease Memory in Psoriasis Skin During Enstilar® and Narrow-Band Ultraviolet B Therapy: The Mempsolar Study

Status
Active Not Recruiting
Phase
Phase 4
Study type
Interventional
Enrollment
12 (estimated)
Sponsor
Aarhus University Hospital · Academic / Other
Sex
All
Age
18 Years – 99 Years
Healthy volunteers
Not accepted

Summary

Psoriasis is a non-communicable chronic immune-mediated disease. Psoriatic skin is characterized by excessive proliferation of skin cells and infiltration of immune cells. The cause of psoriasis is so far unknown. Established therapeutics include topical, oral-systemic, biologic, narrow-band ultraviolet B (NB-UVB). A persistent antipsoriatic effect by the newest biologic therapies has been demonstrated after treatment discontinuation. However, the remittive hallmark of psoriasis suggests the existence of a molecular scar, a kind of disease memory, in clinically healed skin. It has been suggested that this disease memory can be attributed to the tissue-resident memory T (TRM) cell. The main purpose of the study is to investigate whether (NB-UVB) treatment and concomitant Enstilar® treatment can change the amount of TRMs in the skin as well as change the expression in the microenvironment around these cells in the skin from psoriasis patients. In addition, the investigators will investigate whether the treatment can change the quantity and types of other psoriasis-related cells in the skin. In addition to this, the investigators will also examine the effect of treatment on patient-related parameters.

Conditions

Interventions

TypeNameDescription
DRUGEnstilarTopical foam
DRUGPlacebo-vehicleTopical foam

Timeline

Start date
2022-02-16
Primary completion
2024-01-15
Completion
2026-07-15
First posted
2022-01-11
Last updated
2025-10-03

Locations

1 site across 1 country: Denmark

Source: ClinicalTrials.gov record NCT05185258. Inclusion in this directory is not an endorsement.