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

NCT04580537 | Completed Phase 2 DMC

• 3 other identifiers: LAsED2019-002960-29H-19047222
• Study Type: interventional
• Target: 11
• Locations: 1 country
• Sites: 1

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.

Conditions

Nail Psoriasis

Keywords

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

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

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

  Day 1 : Week 24

Study Arms (2)

Laser-assisted Enstilar delivery

EXPERIMENTAL

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

Drug: Enstilar; Device: Ablative fractional laser

Enstilar

ACTIVE COMPARATOR

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

Drug: Enstilar

Interventions

Enstilar DRUG

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

Also known as: Cutaneous foam

Enstilar; Laser-assisted Enstilar delivery

Ablative fractional laser DEVICE

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

Also known as: AFL

Laser-assisted Enstilar delivery

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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)

You may not qualify if:

• 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).

Sponsors & Collaborators

• Bispebjerg Hospital: lead
• LEO Innovation Lab: collaborator

Study Sites (1)

Bispebjerg Hospital

Copenhagen, Capital Region, 2400, Denmark

Location

MeSH Terms

Conditions

Nail Diseases; Psoriasis

Interventions

betamethasone dipropionate, calcipotriol drug combination

Condition Hierarchy (Ancestors)

Skin Diseases; Skin and Connective Tissue Diseases; Skin Diseases, Papulosquamous

Study Officials

• Merete Haedersdal, MD PhD DMSc

  Bispebjerg Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Sponsor-Investigator [Consultant in dermatology, Clinical professor]

Model Details: a proof-of-concept, single-center, prospective, open-label, randomized, clinical trial with an intra-individual comparison of treatments

Study Record Dates

• First Submitted: October 2, 2020
• First Posted: October 8, 2020
• Study Start: October 2, 2020
• Primary Completion: June 1, 2021
• Study Completion: June 1, 2021
• Last Updated: March 2, 2022

Record last verified: 2022-03

Locations

DK (1)