Iontophoresis in Psoriasis

Early Phase 1

Withdrawn

Interventions: Device: Activapatch intellidose 2.5 using inactive Iontophoresis
Device: Activapatch intellidose 2.5 using active Iontophoresis
Drug: Dexamethasone

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.

Recruitment & Eligibility

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.

Arm && Interventions

Group	Intervention	Description
Inactive Iontophoresis	Activapatch intellidose 2.5 using inactive Iontophoresis	One inactive iontophoresis patch will be applied once at the baseline clinical visit. The iontophoresis patches are called Activapatch intellidose 2.5.
Active Iontophoresis	Activapatch intellidose 2.5 using active Iontophoresis	One active iontophoresis patch will be applied once at the baseline clinical visit. The iontophoresis patches are called Activapatch intellidose 2.5.
Active Iontophoresis	Dexamethasone	One active iontophoresis patch will be applied once at the baseline clinical visit. The iontophoresis patches are called Activapatch intellidose 2.5.

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
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.

Locations (1): Wake Forest University Health Sciences
🇺🇸
Winston-Salem, North Carolina, United States