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

Nail Psoriasis Clinical Trial

— 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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04580537
• Other study ID #: LAsED
• Secondary ID: 2019-002960-29H-
• Status: Completed
• Phase: Phase 2
• 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
• 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).

Related Conditions & MeSH terms

• Nail Psoriasis
• Psoriasis

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