NCT03979664

Iontophoresis in Psoriasis

Efficacy of Dexamethasone Iontophoresis in Psoriasis

• Status: Withdrawn
• Phase: EARLY_Phase 1
• Study type: Interventional
• Enrollment: 0 (actual)
• Sponsor: Wake Forest University Health Sciences · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Accepted

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.

Conditions

• Psoriasis
• Psoriasis Vulgaris
• Skin Diseases

Interventions

Type	Name	Description
DEVICE	Activapatch 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.
DEVICE	Activapatch 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.
DRUG	Dexamethasone	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.

Timeline

• Start date: 2021-03-01
• Primary completion: 2021-12-01
• Completion: 2021-12-01
• First posted: 2019-06-07
• Last updated: 2021-04-01

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study
• FDA-regulated device study