Iontophoresis in Psoriasis

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

Official Title
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Efficacy of Dexamethasone Iontophoresis in Psoriasis

Conditions
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Psoriasis, Psoriasis Vulgaris, Skin Diseases

Intervention / Treatment
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* Device: Activapatch intellidose 2.5 using active Iontophoresis
* Device: Activapatch intellidose 2.5 using inactive Iontophoresis
* Drug: Dexamethasone


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model 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.
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Active Iontophoresis<br>One active iontophoresis patch will be applied once at the baseline clinical visit. The iontophoresis patches are called Activapatch intellidose 2.5. | Device: Activapatch intellidose 2.5 using active Iontophoresis<br>* Iontophoresis is a drug delivery system that uses electromigration and electro-osmosis to move charged molecules. Electromigration is the movement of ions across the skin by an electrical field. Positive ions move away from a cathode (positive charge) and towards an anode (negative charge). Negative ions move away from an anode and towards a cathode. Electro-osmosis is the volume movement of positive ions away from the opposite charge. Since skin is negatively charge, positively charged ions penetrate deep in the tissue from the negatively charged skin. 4 The use of iontophoresis was incorporated into medicine in efforts to increase the penetration of medications and avoid injection procedures. Dexamethasone sodium phosphate 4 mg/mL vial will be used in the study. Using a syringe, 2 cc of dexamethasone will be drawn and poured onto the designated medication site on the iontophoresis patch. Once the medication is poured, the patch will be applied on the skin and turned on.<br>Drug: Dexamethasone<br>* Dexamethasone sodium phosphate 4 mg/mL vial will be used in the study. Using a syringe, 2 cc of dexamethasone will be drawn and poured onto the designated medication site on the iontophoresis patch. Once the medication is poured, the patch will be applied on the skin and turned on.<br>|
| Sham Comparator: Inactive Iontophoresis<br>One inactive iontophoresis patch will be applied once at the baseline clinical visit. The iontophoresis patches are called Activapatch intellidose 2.5. | Device: Activapatch intellidose 2.5 using inactive Iontophoresis<br>* Iontophoresis is a drug delivery system that uses electromigration and electro-osmosis to move charged molecules. Electromigration is the movement of ions across the skin by an electrical field. Positive ions move away from a cathode (positive charge) and towards an anode (negative charge). Negative ions move away from an anode and towards a cathode. Electro-osmosis is the volume movement of positive ions away from the opposite charge. Since skin is negatively charge, positively charged ions penetrate deep in the tissue from the negatively charged skin. 4 The use of iontophoresis was incorporated into medicine in efforts to increase the penetration of medications and avoid injection procedures. Inactive medication will be used in the study. Using a syringe, 2 cc of inactive medication will be drawn and poured onto the designated medication site on the iontophoresis patch. Once the medication is poured, the patch will be applied on the skin and turned on.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Static Physician Global Assessment baseline | Static Physician Global Assessment of severity integrates all lesions for overall score. This measure is commonly used as a quick way to quantify disease severity both for clinical studies and non-clinical studies. Scores range from 0=clear to 5=very severe disease. Lower scores denote better outcomes. | Baseline | 
| Static Physician Global Assessment Week 1 | Static Physician Global Assessment of severity integrates all lesions for overall score. This measure is commonly used as a quick way to quantify disease severity both for clinical studies and non-clinical studies. Scores range from 0=clear to 5=very severe disease. Lower scores denote better outcomes. | Change from Baseline to Week 1 | 
| Static Physician Global Assessment Week 2 | Static Physician Global Assessment of severity integrates all lesions for overall score. This measure is commonly used as a quick way to quantify disease severity both for clinical studies and non-clinical studies. Scores range from 0=clear to 5=very severe disease. Lower scores denote better outcomes. | Change from Week 1 to Week 2 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| PsoSat Questionnaire | PsoSat Questionnaire measures patient satisfaction to treatment. This measure was validated. PsoSat Questionniare consists of 8 items that are measured on a 5-item Likert scale. 0= poor agreement to 4= perfect agreement. Higher scores denote better outcome. | Measured at Week 2 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Skin Lesions