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

NCT ID: NCT04580537

Last Updated: 2022-03-02

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE2
• Total Enrollment: 11 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2020-10-02
• Study Completion Date: 2021-06-01

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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

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)

Group Type: EXPERIMENTAL

Enstilar

Intervention Type: DRUG

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

Ablative fractional laser

Intervention Type: DEVICE

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

Enstilar

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

Group Type: ACTIVE_COMPARATOR

Enstilar

Intervention Type: DRUG

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

Interventions

Enstilar

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

Intervention Type: DRUG

Ablative fractional laser

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

Intervention Type: DEVICE

Other Intervention Names

Cutaneous foam; AFL

Eligibility 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).

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

LEO Innovation Lab

UNKNOWN

Sponsor Role: collaborator

Bispebjerg Hospital

OTHER

Sponsor Role: lead

Responsible Party

Merete Haedersdal

Sponsor-Investigator [Consultant in dermatology, Clinical professor]

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Merete Haedersdal, MD PhD DMSc

Role: PRINCIPAL_INVESTIGATOR

Bispebjerg Hospital

Locations

Bispebjerg Hospital

Copenhagen, Capital Region, Denmark

Countries

Denmark

Other Identifiers

2019-002960-29

Identifier Type: EUDRACT_NUMBER

Identifier Source: secondary_id

H-19047222

Identifier Type: REGISTRY

Identifier Source: secondary_id

LAsED

Identifier Type: -

Identifier Source: org_study_id