Clinical Trials Logo

Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT04580537
Other study ID # LAsED
Secondary ID 2019-002960-29H-
Status Completed
Phase Phase 2
First received
Last updated
Start date October 2, 2020
Est. completion date June 1, 2021

Study information

Verified date March 2022
Source Bispebjerg Hospital
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

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 information / eligibility

Status Completed
Enrollment 11
Est. completion date June 1, 2021
Est. primary completion date June 1, 2021
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility 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).

Study Design


Related Conditions & MeSH terms


Intervention

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)

Locations

Country Name City State
Denmark Bispebjerg Hospital Copenhagen Capital Region

Sponsors (2)

Lead Sponsor Collaborator
Bispebjerg Hospital LEO Innovation Lab

Country where clinical trial is conducted

Denmark, 

Outcome

Type Measure Description Time frame Safety issue
Primary Efficacy of topical delivery of Enstilar® with and without laser pre-treatment to improve nail psoriasis Change from baseline to end of treatment in N-NAIL score per nail for each treatment Day1 : Week 24
Secondary Safety profile and local tissue response to laser treatment and Enstilar® application Number of laser- and Enstilar®- emergent adverse events per subject; change in local tissue response score from baseline to Week 12 and Week 24. Day 1 : Week 24
See also
  Status Clinical Trial Phase
Not yet recruiting NCT03209388 - Study of the Efficacy and Safety of Topical P-3073 in the Treatment of Mild to Moderate Psoriatic Fingernail/s Phase 3
Completed NCT00999687 - Evaluation of the Efficacy and Safety of Indigo Naturalis Oil Extract on Psoriatic Nails Phase 2/Phase 3
Completed NCT00581100 - Effects of Etanercept on Nail Psoriasis and Plaque Psoriasis Phase 4
Not yet recruiting NCT03263624 - Efficacy of Combined Fractional Carbon Dioxide Laser and Topical Tazarotene in the Treatment of Psoriatic Nail Disease Phase 4
Completed NCT02606760 - Study to Evaluate the Efficacy and Safety of P-3073 Nail Solution in the Treatment of Nails Affected by Psoriasis Phase 3
Completed NCT04227288 - A Study Evaluating the Efficacy and Tolerability of Enstilar Foam in Patients With Nail Psoriasis Phase 4
Withdrawn NCT03079973 - Study to Evaluate the Efficacy and Safety of P-3073 Nail Solution in the Treatment of Mild to Moderate Psoriatic Fingernail/s Phase 3
Completed NCT04380597 - Observational Study in Patients With Nail Psoriasis Treated With Enstilar® to Assess the Severity Change and the Quality of Life
Completed NCT03991936 - Benefit of Placebo and Different Concentrations of Triamcinolone Acetonide in Nail Psoriasis Phase 4
Recruiting NCT05124080 - An Investigator Initiated Open Label Study Evaluating the Efficacy and Tolerability of Oral Deucravacitinib for the Treatment of Nail Psoriasis Early Phase 1
Completed NCT03757364 - Methotrexate in the Treatment of Distal Interphalangeal Joint Extensor Tendon Enthesopathy in Nail Psoriasis
Completed NCT02016482 - A Study to Evaluate the Safety and Efficacy of Adalimumab in Subjects With Chronic Plaque Psoriasis and Nail Psoriasis Phase 3
Completed NCT02168933 - 308nm Excimer Laser for Treatment of Fingernail Psoriasis N/A
Completed NCT01445886 - Comparison of Indigo Naturalis Oil Extract and Calcipotriol Solution in Treating Psoriasis Phase 2/Phase 3
Not yet recruiting NCT05695833 - Nd:YAG Laser and Radiofrequency in Treatment of Fingernail Psoriasis N/A
Completed NCT03616561 - Quality of Life and Ultrasonographic Assessment of Nail Psoriasis After Treatment With Apremilast (JUST Study)
Completed NCT02235480 - Efficacy and Safety of Tazarotene Gel in Nail Psoriasis Phase 2
Not yet recruiting NCT06150794 - Methotrexate Alone vs Combination With Excimer Light in Nail Psoriasis N/A
Completed NCT03946826 - A Clinical Observation on the Efficacy and Safety of Pulsed Dye Laser (PDL) in the Treatment of Nail Psoriasis N/A
Active, not recruiting NCT05072886 - Study of Efficacy and Safety of Investigational Treatment in Patients With Nail Psoriasis Phase 1