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Iontophoresis in Psoriasis

Primary Purpose

Psoriasis, Psoriasis Vulgaris, Skin Diseases

Status
Withdrawn
Phase
Early Phase 1
Locations
United States
Study Type
Interventional
Intervention
Activapatch intellidose 2.5 using active Iontophoresis
Activapatch intellidose 2.5 using inactive Iontophoresis
Dexamethasone
Sponsored by
Wake Forest University Health Sciences
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Psoriasis focused on measuring Skin Lesions

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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.

Sites / Locations

  • Wake Forest University Health Sciences

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Sham Comparator

Arm Label

Active Iontophoresis

Inactive Iontophoresis

Arm Description

One active iontophoresis patch will be applied once at the baseline clinical visit. The iontophoresis patches are called Activapatch intellidose 2.5.

One inactive iontophoresis patch will be applied once at the baseline clinical visit. The iontophoresis patches are called Activapatch intellidose 2.5.

Outcomes

Primary Outcome Measures

Static Physician Global Assessment 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
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
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

PsoSat Questionnaire
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.

Full Information

First Posted
June 5, 2019
Last Updated
March 29, 2021
Sponsor
Wake Forest University Health Sciences
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1. Study Identification

Unique Protocol Identification Number
NCT03979664
Brief Title
Iontophoresis in Psoriasis
Official Title
Efficacy of Dexamethasone Iontophoresis in Psoriasis
Study Type
Interventional

2. Study Status

Record Verification Date
March 2021
Overall Recruitment Status
Withdrawn
Why Stopped
FDA did not provide approval of the use of the drug for the study
Study Start Date
March 2021 (Anticipated)
Primary Completion Date
December 2021 (Anticipated)
Study Completion Date
December 2021 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Wake Forest University Health Sciences

4. Oversight

Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
Yes
Product Manufactured in and Exported from the U.S.
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Psoriasis, Psoriasis Vulgaris, Skin Diseases
Keywords
Skin Lesions

7. Study Design

Primary Purpose
Treatment
Study Phase
Early Phase 1
Interventional Study Model
Parallel Assignment
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.
Masking
Participant
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.
Allocation
Randomized
Enrollment
0 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Active Iontophoresis
Arm Type
Active Comparator
Arm Description
One active iontophoresis patch will be applied once at the baseline clinical visit. The iontophoresis patches are called Activapatch intellidose 2.5.
Arm Title
Inactive Iontophoresis
Arm Type
Sham Comparator
Arm Description
One inactive iontophoresis patch will be applied once at the baseline clinical visit. The iontophoresis patches are called Activapatch intellidose 2.5.
Intervention Type
Device
Intervention Name(s)
Activapatch intellidose 2.5 using active Iontophoresis
Intervention Description
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.
Intervention Type
Device
Intervention Name(s)
Activapatch intellidose 2.5 using inactive Iontophoresis
Intervention Description
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.
Intervention Type
Drug
Intervention Name(s)
Dexamethasone
Intervention Description
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.
Primary Outcome Measure Information:
Title
Static Physician Global Assessment baseline
Description
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.
Time Frame
Baseline
Title
Static Physician Global Assessment Week 1
Description
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.
Time Frame
Change from Baseline to Week 1
Title
Static Physician Global Assessment Week 2
Description
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.
Time Frame
Change from Week 1 to Week 2
Secondary Outcome Measure Information:
Title
PsoSat Questionnaire
Description
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.
Time Frame
Measured at Week 2

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Steven R Feldman, MD, Ph.D
Organizational Affiliation
Wake Forest University Health Sciences
Official's Role
Principal Investigator
Facility Information:
Facility Name
Wake Forest University Health Sciences
City
Winston-Salem
State/Province
North Carolina
ZIP/Postal Code
27157
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
8818558
Citation
Koo J. Population-based epidemiologic study of psoriasis with emphasis on quality of life assessment. Dermatol Clin. 1996 Jul;14(3):485-96. doi: 10.1016/s0733-8635(05)70376-4.
Results Reference
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PubMed Identifier
16365254
Citation
Gelfand JM, Weinstein R, Porter SB, Neimann AL, Berlin JA, Margolis DJ. Prevalence and treatment of psoriasis in the United Kingdom: a population-based study. Arch Dermatol. 2005 Dec;141(12):1537-41. doi: 10.1001/archderm.141.12.1537.
Results Reference
background
PubMed Identifier
16343026
Citation
Kimball AB, Jacobson C, Weiss S, Vreeland MG, Wu Y. The psychosocial burden of psoriasis. Am J Clin Dermatol. 2005;6(6):383-92. doi: 10.2165/00128071-200506060-00005.
Results Reference
background
PubMed Identifier
23590287
Citation
Roustit M, Blaise S, Cracowski JL. Trials and tribulations of skin iontophoresis in therapeutics. Br J Clin Pharmacol. 2014 Jan;77(1):63-71. doi: 10.1111/bcp.12128.
Results Reference
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PubMed Identifier
22196293
Citation
Stefanou A, Marshall N, Holdan W, Siddiqui A. A randomized study comparing corticosteroid injection to corticosteroid iontophoresis for lateral epicondylitis. J Hand Surg Am. 2012 Jan;37(1):104-9. doi: 10.1016/j.jhsa.2011.10.005.
Results Reference
background
PubMed Identifier
25917315
Citation
Chow C, Simpson MJ, Luger TA, Chubb H, Ellis CN. Comparison of three methods for measuring psoriasis severity in clinical studies (Part 1 of 2): change during therapy in Psoriasis Area and Severity Index, Static Physician's Global Assessment and Lattice System Physician's Global Assessment. J Eur Acad Dermatol Venereol. 2015 Jul;29(7):1406-14. doi: 10.1111/jdv.13132. Epub 2015 Apr 27.
Results Reference
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PubMed Identifier
27073875
Citation
Radtke MA, Spehr C, Reich K, Rustenbach SJ, Feuerhahn J, Augustin M. Treatment Satisfaction in Psoriasis: Development and Use of the PsoSat Patient Questionnaire in a Cross-Sectional Study. Dermatology. 2016;232(3):334-43. doi: 10.1159/000444635. Epub 2016 Apr 14.
Results Reference
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PubMed Identifier
15336476
Citation
Zempsky WT, Sullivan J, Paulson DM, Hoath SB. Evaluation of a low-dose lidocaine iontophoresis system for topical anesthesia in adults and children: a randomized, controlled trial. Clin Ther. 2004 Jul;26(7):1110-9. doi: 10.1016/s0149-2918(04)90183-x.
Results Reference
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PubMed Identifier
23425157
Citation
Le QV, Howard A. Dexamethasone iontophoresis for the treatment of nail psoriasis. Australas J Dermatol. 2013 May;54(2):115-9. doi: 10.1111/ajd.12029. Epub 2013 Feb 21.
Results Reference
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Iontophoresis in Psoriasis

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