Clinical trial NCT03979664: Iontophoresis in Psoriasis
Official title: Efficacy of Dexamethasone Iontophoresis in Psoriasis
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: EARLY_PHASE1
Conditions: Psoriasis
Psoriasis Vulgaris
Skin Diseases
Keywords: Skin Lesions
Lead sponsor: Wake Forest University Health Sciences
Sponsor class: OTHER
First posted: 2019-06-07
Enrollment: 0
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
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.
Primary purpose: TREATMENT

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.

Eligibility criteria: 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.

Primary outcomes:
measure: Static Physician Global Assessment baseline
timeFrame: Baseline
measure: Static Physician Global Assessment Week 1
timeFrame: Change from Baseline to Week 1
measure: Static Physician Global Assessment Week 2
timeFrame: Change from Week 1 to Week 2
Secondary outcomes:
measure: PsoSat Questionnaire
timeFrame: Measured at Week 2
Other outcomes:
Locations:
city: Winston-Salem
country: United States
facility: Wake Forest University Health Sciences
state: North Carolina
Study officials:
affiliation: Wake Forest University Health Sciences
name: Steven R Feldman, MD, Ph.D
role: PRINCIPAL_INVESTIGATOR
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