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

Primary Purpose

Nail Psoriasis

Status

Completed

Phase

Phase 2

Locations

Denmark

Study Type

Interventional

Intervention

Enstilar

Ablative fractional laser

About this trial

This is an interventional treatment trial for Nail Psoriasis focused on measuring Nail disease, Psoriasis, Laser-assisted drug delivery, Enstilar

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion criteria

Informed consent obtained before any trial-related activities.
At least 18 years of age (inclusive)
Confirmed diagnosis of psoriatic disease with signs of nail psoriasis on at least 2 digits
Minimum nail involvement as assessed by treating physician (N-NAIL score of ≥ 2 for at least two individual nails)

Exclusion criteria

Insufficient knowledge of written and spoken Danish.
Pregnant and lactating women and women who intend to become pregnant during the trial
Pre-existing clinical manifestations of long-term side effects of corticosteroid use including but not limited to skin atrophy or telangiectasias on fingers
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
Any non-psoriatic disease activity within test areas
Significant history or current evidence of chronic infectious disease, systemic disorders, or organ dysfunction where the use of Enstilar is contraindicated.
Known predisposition for hypertrophic scar formation.
Known allergy to any of the components of Enstilar®.
Current treatment with systemically or locally acting medications which might counter or influence the trial aim
Received any drug as part of a research trial within 30 days prior to initial trial dosing.
Artificial nail enhancement or damages associated with it, including (semi-) permanent nail polish e.g. acrylic based gels.
Ongoing fungal infections of psoriatic nails
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
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).

Sites / Locations

Bispebjerg Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Laser-assisted Enstilar delivery

Enstilar

Arm Description

Ablative fractional laser (AFL) pre-treatment + daily use of Enstilar (cutaneous foam: 0.5 mg/g betamethasone dipropionate, 0.05mg/g calcipotriol)

Daily use of Enstilar (cutaneous foam: 0.5 mg/g betamethasone dipropionate, 0.05mg/g calcipotriol)

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

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.

Full Information

NCT ID

NCT04580537

First Posted

October 2, 2020

Last Updated

March 1, 2022

Sponsor

Bispebjerg Hospital

Collaborators

LEO Innovation Lab

1. Study Identification

Unique Protocol Identification Number

NCT04580537

Brief Title

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

Acronym

LAsED

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

Study Type

Interventional

2. Study Status

Record Verification Date

March 2022

Overall Recruitment Status

Completed

Study Start Date

October 2, 2020 (Actual)

Primary Completion Date

June 1, 2021 (Actual)

Study Completion Date

June 1, 2021 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

Bispebjerg Hospital

Collaborators

LEO Innovation Lab

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Product Manufactured in and Exported from the U.S.

Data Monitoring Committee

Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Nail Psoriasis

Keywords

Nail disease, Psoriasis, Laser-assisted drug delivery, Enstilar

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 2

Interventional Study Model

Parallel Assignment

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)

Allocation

Randomized

Enrollment

11 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Laser-assisted Enstilar delivery

Arm Type

Experimental

Arm Description

Ablative fractional laser (AFL) pre-treatment + daily use of Enstilar (cutaneous foam: 0.5 mg/g betamethasone dipropionate, 0.05mg/g calcipotriol)

Arm Title

Enstilar

Arm Type

Active Comparator

Arm Description

Daily use of Enstilar (cutaneous foam: 0.5 mg/g betamethasone dipropionate, 0.05mg/g calcipotriol)

Intervention Type

Drug

Intervention Name(s)

Enstilar

Other Intervention Name(s)

Cutaneous foam

Intervention Description

Daily application on affected fingers (nail plates, nail folds, and surrounding skin)

Intervention Type

Device

Intervention Name(s)

Ablative fractional laser

Other Intervention Name(s)

AFL

Intervention Description

Pre-treatment of affected fingers (nail plates, nail folds)

Primary Outcome Measure Information:

Title

Efficacy of topical delivery of Enstilar® with and without laser pre-treatment to improve nail psoriasis

Description

Change from baseline to end of treatment in N-NAIL score per nail for each treatment

Time Frame

Day1 : Week 24

Secondary Outcome Measure Information:

Title

Safety profile and local tissue response to laser treatment and Enstilar® application

Description

Number of laser- and Enstilar®- emergent adverse events per subject; change in local tissue response score from baseline to Week 12 and Week 24.

Time Frame

Day 1 : Week 24

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion criteria Informed consent obtained before any trial-related activities. At least 18 years of age (inclusive) Confirmed diagnosis of psoriatic disease with signs of nail psoriasis on at least 2 digits Minimum nail involvement as assessed by treating physician (N-NAIL score of ≥ 2 for at least two individual nails) Exclusion criteria Insufficient knowledge of written and spoken Danish. Pregnant and lactating women and women who intend to become pregnant during the trial Pre-existing clinical manifestations of long-term side effects of corticosteroid use including but not limited to skin atrophy or telangiectasias on fingers 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 Any non-psoriatic disease activity within test areas Significant history or current evidence of chronic infectious disease, systemic disorders, or organ dysfunction where the use of Enstilar is contraindicated. Known predisposition for hypertrophic scar formation. Known allergy to any of the components of Enstilar®. Current treatment with systemically or locally acting medications which might counter or influence the trial aim Received any drug as part of a research trial within 30 days prior to initial trial dosing. Artificial nail enhancement or damages associated with it, including (semi-) permanent nail polish e.g. acrylic based gels. Ongoing fungal infections of psoriatic nails 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 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).

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Merete Haedersdal, MD PhD DMSc

Organizational Affiliation

Bispebjerg Hospital

Official's Role

Principal Investigator

Facility Information:

Facility Name

Bispebjerg Hospital

City

Copenhagen

State/Province

Capital Region

ZIP/Postal Code

2400

Country

Denmark

12. IPD Sharing Statement

Learn more about this trial

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

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