Ignite Creation Date:
2025-12-25 @ 12:18 AM
Ignite Modification Date:
2025-12-25 @ 10:21 PM
Study NCT ID:
NCT05185258
Status:
ACTIVE_NOT_RECRUITING
Last Update Posted:
2025-10-03
First Post:
2021-11-01
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Residual Disease MEMory in PSOriasis Skin During EnstiLAR® and Narrow-band Ultraviolet B Therapy: The MEMPSOLAR Study
Sponsor:
Aarhus University Hospital
Organization:
Study Overview
Official Title:
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
Status Verified Date:
2025-09
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
MEMPSOLAR
Brief 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.
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.
Detailed Description:
None
Study Oversight
Has Oversight DMC:
True
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
False
Is an FDA AA801 Violation?: