Accepts Healthy Volunteers
Healthy volunteers are participants who do not have a disease or condition, or related conditions or symptoms
An interventional clinical study is where participants are assigned to receive one or more interventions (or no intervention) so that researchers can evaluate the effects of the interventions on biomedical or health-related outcomes.
An observational clinical study is where participants identified as belonging to study groups are assessed for biomedical or health outcomes.
Searching Both is inclusive of interventional and observational studies.
|Eligible Ages||18 Years and Over|
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) 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).
This trial id was obtained from ClinicalTrials.gov, a service of the U.S. National Institutes of Health, providing information on publicly and privately supported clinical studies of human participants with locations in all 50 States and in 196 countries.
Phase 1: Studies that emphasize safety and how the drug is metabolized and excreted in humans.
Phase 2: Studies that gather preliminary data on effectiveness (whether the drug works in people who have a certain disease or condition) and additional safety data.
Phase 3: Studies that gather more information about safety and effectiveness by studying different populations and different dosages and by using the drug in combination with other drugs.
Phase 4: Studies occurring after FDA has approved a drug for marketing, efficacy, or optimal use.
The sponsor is the organization or person who oversees the clinical study and is responsible for analyzing the study data.
The person who is responsible for the scientific and technical direction of the entire clinical study.
|Merete Haedersdal, MD PhD DMSc|
|Principal Investigator Affiliation||Bispebjerg Hospital|
Category of organization(s) involved as sponsor (and collaborator) supporting the trial.
The disease, disorder, syndrome, illness, or injury that is being studied.
Experimental: Laser-assisted Enstilar delivery
Ablative fractional laser (AFL) pre-treatment + daily use of Enstilar (cutaneous foam: 0.5 mg/g betamethasone dipropionate, 0.05mg/g calcipotriol)
Active Comparator: Enstilar
Daily use of Enstilar (cutaneous foam: 0.5 mg/g betamethasone dipropionate, 0.05mg/g calcipotriol)
Drug: - Enstilar
Daily application on affected fingers (nail plates, nail folds, and surrounding skin)
Device: - Ablative fractional laser
Pre-treatment of affected fingers (nail plates, nail folds)
Contact a Trial Team
If you are interested in learning more about this trial, find the trial site nearest to your location and contact the site coordinator via email or phone. We also strongly recommend that you consult with your healthcare provider about the trials that may interest you and refer to our terms of service below.