Assessing the Efficacy of Image-guided Laser-assisted Enstilar® Delivery for Treatment of Psoriatic Nails

Study Purpose

The trial is conducted to investigate the clinical efficacy of a combination product containing calcipotriol and betamethasone formulated as an aerosol foam (Enstilar ©) for the treatment of nail psoriasis in conjunction with physical pre-treatment using a fractionally ablative carbon dioxide laser (AFL). It is hypothesized, based on preclinical data and comparable clinical trials, that laser processing prior to topical administration will lead to increased drug distribution, and thereby increase the efficacy of Enstilar® in treating nail psoriasis.

Recruitment Criteria

Accepts Healthy Volunteers

Healthy volunteers are participants who do not have a disease or condition, or related conditions or symptoms

Study Type

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
Gender All
More Inclusion & Exclusion 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) 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).

Trial Details

Trial ID:

This trial id was obtained from, 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.

Phase 2
Lead Sponsor

The sponsor is the organization or person who oversees the clinical study and is responsible for analyzing the study data.

Bispebjerg Hospital
Principal Investigator

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
Agency Class

Category of organization(s) involved as sponsor (and collaborator) supporting the trial.

Overall Status Recruiting
Countries Denmark

The disease, disorder, syndrome, illness, or injury that is being studied.

Nail Psoriasis
Arms & Interventions


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

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International Sites

Bispebjerg Hospital, Copenhagen, Capital Region, Denmark




Bispebjerg Hospital

Copenhagen, Capital Region, 2400

Site Contact

Vinzent K Ortner, MD

+45 52177729

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