Iontophoresis in Psoriasis

• Status: Withdrawn
• Trial end date: 2021-12-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Early Phase 1
• Accepts Healthy Volunteers?: Accepts Healthy Volunteers

Details

• Lead Sponsor: Wake Forest University Health Sciences
• Treatments: BB 1101; Dexamethasone; Dexamethasone 21-phosphate; Dexamethasone acetate

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.