Nail psoriasis MedDRA version: 20.0 Level: HLT Classification code 10065874 Term: Psoriatic conditions System Organ Class: 10040785 - Skin and subcutaneous tissue disorders MedDRA version: 20.0 Level: PT Classification code 10037153 Term: Psoriasis System Organ Class: 10040785 - Skin and subcutaneous tissue disorders MedDRA version: 21.1 Level: PT Classification code 10037162 Term: Psoriatic arthropathy System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders MedDRA ver
Conditions
Interventions
Trade Name: Enstilar
Product Name: Enstilar
Pharmaceutical Form: Cutaneous foam
INN or Proposed INN: Betamethasone dipropionate
Other descriptive name: BETAMETHASONE DIPROPIONATE
Concentration unit: m
Sponsors
Merete Haedersdal [Bispebjerg Hospital]
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Informed consent obtained before any trial-related activities. 2. At least 18 years of age (inclusive) 3. Confirmed diagnosis of psoriatic disease with signs of nail psoriasis* on at least 2 digits 4. Minimum nail involvement as assessed by treating physician (N-NAIL score of = 2 for at least two individual nails) Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range 11 F.1.3 Elderly (>=65 years) no F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: 1. Insufficient knowledge of written and spoken Danish. 2. Pregnant and lactating women and women who intend to become pregnant during the trial* 3. Pre-existing clinical manifestations of long-term side effects of corticosteroid use including but not limited to skin atrophy or telangiectasias on fingers 4. Presence of any skin condition or coloration (marked suntan, hyperpigmentation, smoking-induced staining, tattoos or body art) that would interfere with the evaluation of the clinical response in the test sites or assessment 5. Any non-psoriatic disease activity within test areas 6. Significant history or current evidence of chronic infectious disease, systemic disorders, or organ dysfunction where the use of Enstilar is contraindicated. 7. Known predisposition for hypertrophic scar formation. 8. Known allergy to any of the components of Enstilar®. 9. Current treatment with systemically or locally acting medications which might counter or influence the trial aim 10. Received any drug as part of a research trial within 30 days prior to initial trial dosing. 11. Artificial nail enhancement or damages associated with it, including (semi-) permanent nail polish e.g. acrylic based gels. 12. Ongoing fungal infections of psoriatic nails 13. Close affiliation with the investigator (e.g. a close relative) or persons working at the respective trial site or the participant is an employee of the sponsor 14. In the opinion of the investigator, the participant is unlikely to comply with the Clinical Trial Protocol (e.g. alcoholism, drug dependency or psychotic state).
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: Efficacy of Enstilar for treatment of nail psoriasis using laser pretreatment;Secondary Objective: Safety of Enstilar for treatment of nail psoriasis using laser pretreatment;Primary end point(s): Change from baseline (Day 1) to end of treatment (Week 24) in N-NAIL score per nail for each treatment. ;Timepoint(s) of evaluation of this end point: Day 1 and Week 24 | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): Number of laser- and Enstilar®- emergent adverse events per subject ;Timepoint(s) of evaluation of this end point: Day 1, Week 1, Week 6, Week 12, Week 24; Participants will be encouraged to communicate any AE occurring between trial visits to their treating study physician at their earliest convenience. | — |
Countries
Denmark
Contacts
Public ContactDepartment of Dermatology [D92]
Bispebjerg Hospital
Outcome results
None listed