Assessing the Impact of Pioglitazone on Skin Barrier Function in Atopic Dermatitis Patients
|ClinicalTrials.gov Identifier: NCT01695707|
Recruitment Status : Withdrawn (Insufficient Funding.)
First Posted : September 28, 2012
Last Update Posted : December 2, 2014
|Condition or disease||Intervention/treatment||Phase|
|Atopic Dermatitis||Drug: Pioglitazone Drug: Placebo (for pioglitazone)||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||0 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)|
|Official Title:||Assessing the Impact of Pioglitazone on Skin Barrier Function in Atopic Dermatitis Patients|
|Study Start Date :||March 2013|
|Estimated Primary Completion Date :||January 2014|
|Estimated Study Completion Date :||June 2014|
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
- Noninvasive barrier measurements (TEWL)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 permeabilitySkin 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.
- mRNAEx vivo assessment of mRNA expression of key epidermal barrier proteins will also be performed on the biopsy specimens.
- Skin IrritancyThe 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).
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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|