Laser-assisted Topical Administration of Etanercept (Enbrel®) in Patients With Mild to Moderate Plaque-type Psoriasis

Summary

The purpose of this study is to assess the feasibility and safety of topical administration of etanercept via AFL micropores to psoriatic plaques in patients with mild to moderate plaque-type psoriasis.

While a wide variety of therapeutic innovations to treat moderate-to-severe psoriasis (accounting for around 30% of the cases) become available each year, there are few innovations for topical therapies to treat mild/localized psoriasis (accounting for around 70% of the cases). Given that only about half of the patients respond adequately to the current standard of care, the topical application of a fixed combination of calcipotriole and betamethasone, there is a medical need for better topical therapies.

Etanercept has been used successfully to treat moderate-to-severe plaque-type psoriasis in children and adults for more than a decade. Its standard route of application is through subcutaneous injections. Different dosing regimens have been used: 1 x 50 mg or 2 x 50 mg per week as well as 1 x 25 mg or 2 x 25 mg per week. Under these regimens, etanercept has a well-established favorable long-term safety record, with injection site reactions (pain, swelling) the most frequently reported side effects. However, rare but serious side effects such as serious opportunistic infections resulting from immune system inhibition common to anti-TNF agents limit its systemic use to these patients. For this reason, a localized topical alternative route of administration would be desirable. However, the large molecular size and chemical nature of etanercept prevent it from crossing the epidermal barrier. A CE certified ablative fractional laser (AFL) device with Er:YAG source will be used to create micropores in plaques to allow local delivery of etanercept directly into psoriatic plaques.

Conditions

• Psoriatic Plaque

Interventions

DEVICE

Laser microporation alone

The Er:YAG laser induced microporation of 5 cm2 of a plaque surface, followed by application of an OpSiteTM Flexigrid Transparent Dressing for 4 hours. This treatment will also be repeated twice weekly for 8 weeks.

DRUG

Standard of care-daily administration of Daivobet

The other control treatment is Daivobet®, which is applied topically daily for 8 weeks on one pre-selected randomized plaque.

DRUG

Laser microporation + topical application of Etanercept

Immediately following microporation of a 5 cm² area of the designated plaque with the P.L.E.A.S.E.® Professional laser, 0.0625 ml of Etanercept (50 mg/ml) solution for injection in pre-filled syringes will be applied to the microporated surface of the lesion. The treated area will then be covered with OpSiteTM Flexigrid Transparent Dressing for 4 hours. This treatment procedure will be repeated twice weekly for 8 weeks.

Sponsors & Collaborators

• Pantec Biosolutions AG

  lead INDUSTRY

Principal Investigators

• Wolf-Henning Boehncke, Prof. · HUG

Study Design

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

SINGLE

Model

PARALLEL

Eligibility

Min Age

18 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2016-11-30

Primary Completion

2017-12-31

Completion

2018-06-30

Countries

• Switzerland

Study Locations