Iontophoresis in Psoriasis

Wake Forest University (WFU)

Status and phase: Withdrawn; Early Phase 1

Conditions: Psoriasis; Skin Diseases; Psoriasis Vulgaris

Treatments: Drug: Dexamethasone; Device: Activapatch intellidose 2.5 using inactive Iontophoresis; Device: Activapatch intellidose 2.5 using active Iontophoresis

Study type: Interventional

Funder types: Other

Identifiers

NCT03979664

IRB00058450

Details and patient eligibility

About

Iontophoresis potentially may be a good alternative to improved delivery of corticosteroids. Study Investigators propose to use iontophoresis to increase dexamethasone delivery into thick psoriasis plaques. The primary purpose of this study is to assess whether dexamethasone sodium phosphate iontophoresis is an effective local therapy for psoriasis. The objective of the study is to determine the efficacy of dexamethasone sodium phosphate iontophoresis for psoriasis.

Full description

Subjects who meet the selection criteria will be offered an opportunity to take part in this study. This will be a prospective controlled study. After written informed consent, 20 subjects with symmetric thick plaque psoriasis lesions on the extremities and/or trunk will be enrolled and randomized to receive one activated iontophoresis patch containing dexamethasone sodium phosphate and another inactive control iontophoresis patch containing dexamethasone sodium phosphate on each limb containing a thick psoriatic plaque. Members of the research team will apply the patches. After application of the patch, subjects will be asked to return to the clinic in 1 week and 2 weeks. Efficacy will be measured at the 1-week and 2-week follow-up visit using a scale for erythema, scale, and thickness called the static Physician Global Assessment (sPGA) and subject satisfaction to treatment will be measured at the 2 week-follow-up using the PsoSat Questionnaire.

Sex: All

Ages: 18+ years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

• Greater than or equal to 18 years of age.
• Subjects with diagnosed plaque-type psoriasis that is stable.
• Similar psoriasis plaques found on each limb and/or different sides of the trunk.
• Willingness to attend all scheduled visits and complete the study.
• Ability to understand and sign an informed consent form.

Exclusion criteria

• Known allergy to dexamethasone or any component of the formulation and iontophoresis components.
• Change in the use of systemic therapy in psoriasis within 4 weeks prior to applying iontophoresis patches (to allow time for washout).
• Use of topical therapy (including coal tar, salicylic acid, topical corticosteroids, vitamin D, vitamin A, urea) or recent phototherapy for psoriasis within 2 weeks prior to applying iontophoresis patches (to allow time for washout).
• Pregnancy or breast feeding women.
• Any other condition, in the judgement of the investigator, would put the subject at unacceptable risk to participate.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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0 participants in 2 patient groups

Active Iontophoresis

Active Comparator group

Description:

One active iontophoresis patch will be applied once at the baseline clinical visit. The iontophoresis patches are called Activapatch intellidose 2.5.

Treatment:

Drug: Dexamethasone

Device: Activapatch intellidose 2.5 using active Iontophoresis

Inactive Iontophoresis

Sham Comparator group

Description:

One inactive iontophoresis patch will be applied once at the baseline clinical visit. The iontophoresis patches are called Activapatch intellidose 2.5.

Treatment:

Device: Activapatch intellidose 2.5 using inactive Iontophoresis