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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04580537
Recruitment Status : Recruiting
First Posted : October 8, 2020
Last Update Posted : October 8, 2020
Sponsor:
Collaborator:
LEO Innovation Lab
Information provided by (Responsible Party):
Merete Haedersdal, Bispebjerg Hospital

Brief 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.

Condition or disease Intervention/treatment Phase
Nail Psoriasis Drug: Enstilar Device: Ablative fractional laser Phase 2

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 25 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: a proof-of-concept, single-center, prospective, open-label, randomized, clinical trial with an intra-individual comparison of treatments
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Assessing the Efficacy of Image-guided Laser-assisted Enstilar® Delivery for Treatment of Psoriatic Nails - a Proof-of-concept, Single-center, Prospective, Open-label, Randomized, Clinical Trial With an Intra-individual Comparison of Treatments
Actual Study Start Date : October 2, 2020
Estimated Primary Completion Date : April 2021
Estimated Study Completion Date : June 2021

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Psoriasis

Arm Intervention/treatment
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)
Drug: Enstilar
Daily application on affected fingers (nail plates, nail folds, and surrounding skin)
Other Name: Cutaneous foam

Device: Ablative fractional laser
Pre-treatment of affected fingers (nail plates, nail folds)
Other Name: AFL

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)
Other Name: Cutaneous foam




Primary Outcome Measures :
  1. Efficacy of topical delivery of Enstilar® with and without laser pre-treatment to improve nail psoriasis [ Time Frame: Day1 : Week 24 ]
    Change from baseline to end of treatment in N-NAIL score per nail for each treatment


Secondary Outcome Measures :
  1. Safety profile and local tissue response to laser treatment and Enstilar® application [ Time Frame: Day 1 : Week 24 ]
    Number of laser- and Enstilar®- emergent adverse events per subject; change in local tissue response score from baseline to Week 12 and Week 24.



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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).

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04580537


Contacts
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Contact: Vinzent K Ortner, MD +45 52177729 vinzent.kevin.ortner@regionh.dk

Locations
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Denmark
Bispebjerg Hospital Recruiting
Copenhagen, Capital Region, Denmark, 2400
Contact: Vinzent K Ortner, MD       vinzent.kevin.ortner@regionh.dk   
Sponsors and Collaborators
Bispebjerg Hospital
LEO Innovation Lab
Investigators
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Principal Investigator: Merete Haedersdal, MD PhD DMSc Bispebjerg Hospital
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Responsible Party: Merete Haedersdal, Sponsor-Investigator [Consultant in dermatology, Clinical professor], Bispebjerg Hospital
ClinicalTrials.gov Identifier: NCT04580537    
Other Study ID Numbers: LAsED
2019-002960-29 ( EudraCT Number )
H-19047222 ( Registry Identifier: De Videnskabsetiske Komitéer )
First Posted: October 8, 2020    Key Record Dates
Last Update Posted: October 8, 2020
Last Verified: October 2020

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Product Manufactured in and Exported from the U.S.: No
Keywords provided by Merete Haedersdal, Bispebjerg Hospital:
Nail disease
Psoriasis
Laser-assisted drug delivery
Enstilar
Additional relevant MeSH terms:
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Psoriasis
Skin Diseases, Papulosquamous
Skin Diseases
Calcipotriene
Dermatologic Agents