Psoriasis, Psoriasis Vulgaris, Skin Diseases
Conditions
Keywords
Skin Lesions
Brief summary
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
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.
Interventions
DEVICEActivapatch intellidose 2.5 using active Iontophoresis
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.
DEVICEActivapatch intellidose 2.5 using inactive Iontophoresis
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.
DRUGDexamethasone
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.
Sponsors
Wake Forest University Health Sciences
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Subject)
Masking description
Without the subject knowing, one patch will be turned on whereas the other patch will be turned off. The patch will be turned on pulling a tab found in the middle of the butterfly-shaped patch. The other patch will be turned off by not pulling the tab found in the middle of the butterfly-shaped patch.
Intervention 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.
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
Yes
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Static Physician Global Assessment baseline | 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. |
| Static Physician Global Assessment Week 1 | Change from Baseline to 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. |
| Static Physician Global Assessment Week 2 | Change from Week 1 to 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| PsoSat Questionnaire | Measured at Week 2 | 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. |
Countries
United States
Outcome results
None listed