- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03979664
Iontophoresis in Psoriasis
March 29, 2021 updated by: Wake Forest University Health Sciences
Efficacy of Dexamethasone Iontophoresis in Psoriasis
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.
Study Overview
Status
Withdrawn
Conditions
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.
Study Type
Interventional
Phase
- Early Phase 1
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
North Carolina
-
Winston-Salem, North Carolina, United States, 27157
- Wake Forest University Health Sciences
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years and older (ADULT, OLDER_ADULT)
Accepts Healthy Volunteers
Yes
Genders Eligible for Study
All
Description
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.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: TREATMENT
- Allocation: RANDOMIZED
- Interventional Model: PARALLEL
- Masking: SINGLE
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
ACTIVE_COMPARATOR: Active Iontophoresis
One active iontophoresis patch will be applied once at the baseline clinical visit.
The iontophoresis patches are called Activapatch intellidose 2.5.
|
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.
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.
|
SHAM_COMPARATOR: Inactive Iontophoresis
One inactive iontophoresis patch will be applied once at the baseline clinical visit.
The iontophoresis patches are called Activapatch intellidose 2.5.
|
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.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Static Physician Global Assessment baseline
Time Frame: 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.
|
Baseline
|
Static Physician Global Assessment Week 1
Time Frame: 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.
|
Change from Baseline to Week 1
|
Static Physician Global Assessment Week 2
Time Frame: 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.
|
Change from Week 1 to Week 2
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
PsoSat Questionnaire
Time Frame: 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.
|
Measured at Week 2
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
General Publications
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (ANTICIPATED)
March 1, 2021
Primary Completion (ANTICIPATED)
December 1, 2021
Study Completion (ANTICIPATED)
December 1, 2021
Study Registration Dates
First Submitted
June 5, 2019
First Submitted That Met QC Criteria
June 6, 2019
First Posted (ACTUAL)
June 7, 2019
Study Record Updates
Last Update Posted (ACTUAL)
April 1, 2021
Last Update Submitted That Met QC Criteria
March 29, 2021
Last Verified
March 1, 2021
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
- Skin Diseases, Papulosquamous
- Psoriasis
- Skin Diseases
- Physiological Effects of Drugs
- Autonomic Agents
- Peripheral Nervous System Agents
- Anti-Inflammatory Agents
- Antineoplastic Agents
- Antiemetics
- Gastrointestinal Agents
- Glucocorticoids
- Hormones
- Hormones, Hormone Substitutes, and Hormone Antagonists
- Antineoplastic Agents, Hormonal
- Dexamethasone
Other Study ID Numbers
- IRB00058450
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
NO
Drug and device information, study documents
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
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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