Saves the questions and what to expect into your notes, next to the visit they belong to.
Keep this study
Lead
Bispebjerg Hospital
With
LEO Innovation Lab
Age
18–any
Sex
ALL
Healthy volunteers
Not accepted
You may be eligible if
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)
You may not be if
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).
