Assessing the Impact of Pioglitazone on Skin Barrier Function in Atopic Dermatitis Patients
Many patients with eczema (atopic dermatitis) have an inherent defect in their skin barrier as demonstrated by high water loss. In laboratory conditions, studies have shown that pioglitazone restores the skin barrier function in skin from eczema patients. The purpose of this study is to determine if taking pioglitazone improves the skin barrier function in people with eczema.
|Study Design:||Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
|Official Title:||Assessing the Impact of Pioglitazone on Skin Barrier Function in Atopic Dermatitis Patients|
- Noninvasive barrier measurements (TEWL) [ Designated as safety issue: No ]Transepidermal Water Loss (TEWL) will be measured at multiple time points throughout the study as a surrogate for skin barrier integrity.
- Transepithelial electrical resistance (TEER) and permeability [ Designated as safety issue: No ]Skin biopsies will be performed twice during the study. The integrity of the skin barrier will be assessed in the lab by transepithelial electrical resistance (TEER) and permeability of the biopsy specimens.
- mRNA [ Designated as safety issue: No ]Ex vivo assessment of mRNA expression of key epidermal barrier proteins will also be performed on the biopsy specimens.
- Skin Irritancy [ Designated as safety issue: No ]The clinical efficacy of PIO will be assessed by quantifying the skin response to a model irritant, sodium lauryl sulphate (SLS) at several time points. Subjects will be exposed for 24 h on the dominant inner arm to SLS at three concentrations (wt/vol in water - 0.125, 0.5 and 2%) (Fluka) using standard patch test reagents (Finn chambers of 18-mm diam, Filter Discs & Scanpor tape). Before application and at several time points after removal, TEWL and erythema will be measured at the exposed site and at a control site. Erythema will be measured using a colorimeter (Minolta CR-200).
|Study Start Date:||March 2013|
|Estimated Study Completion Date:||June 2014|
|Estimated Primary Completion Date:||January 2014 (Final data collection date for primary outcome measure)|
Placebo Comparator: Placebo
Subjects randomized to placebo will receive opaque size "00" gelatin capsules containing 240mg lactose. As with the intervention group, 1 capsule will be taken by each day throughout the treatment period.
Drug: Placebo (for pioglitazone)
see Arm Description
Subjects randomized to pioglitazone will receive opaque size "00" gelatin capsules containing pioglitazone. For the first 3 weeks, capsules will contain 30 mg pioglitazone. For the remaining 9 weeks of the treatment period, capsules will contain 45 mg pioglitazone unless subjects are unable to tolerate this increased dose.
One capsule will be taken by each day throughout the treatment period.
see Arm Description
Other Name: Actos
Enrolled patients will be randomized to either placebo or pioglitazone. Each randomized subject will have a skin biopsy and skin irritancy assay performed prior to treatment and at the end of 12 weeks of treatment. Noninvasive barrier measurements including transepidermal water loss will be recorded at all study visits.
Please refer to this study by its ClinicalTrials.gov identifier: NCT01695707
|United States, New York|
|University of Rochester Medical Center|
|Rochester, New York, United States, 14642|
|Principal Investigator:||Lisa A Beck, MD||University of Rochester|