Assessing the Impact of Pioglitazone on Skin Barrier Function in Atopic Dermatitis Patients

NCT01695707 | Withdrawn DMC

• 2 other identifiers: RSRB000410781R21AR062357
• Study Type: interventional
• Target: N/A
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Atopic Dermatitis

Keywords

atopic dermatitis; eczema

Outcome Measures

Primary Outcomes (3)

• 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 permeability

  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

  Ex vivo assessment of mRNA expression of key epidermal barrier proteins will also be performed on the biopsy specimens.

Secondary Outcomes (1)

• Skin Irritancy

Study Arms (2)

Placebo

PLACEBO COMPARATOR

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)

Pioglitazone

EXPERIMENTAL

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.

Drug: Pioglitazone

Interventions

Pioglitazone DRUG

see Arm Description

Also known as: Actos

Pioglitazone

Placebo (for pioglitazone) DRUG

see Arm Description

Placebo

Eligibility Criteria

• Age: 18 Years - 55 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• i. Moderate to Severe AD: EASI ≥ 10 ii. Active Atopic Dermatitis: Subjects must have within the last 3 months according to medical records or by medical exam of the investigator:
• Pruritus
• Eczema (acute, subacute, chronic)
• I. Typical morphology and age-specific patterns - Patterns include (1) facial, neck, and extensor involvement in infants and children, (2) current or prior flexural lesions in any age group, (3) sparing groin and axillary regions.
• II. Chronic or relapsing history
• iii. Extrinsic they must also meet both of the following: serum total IgE ≥ 1.5 S.D. greater than the age-matched norms and positive multi-allergen RAST (Phadiatop).
• Additionally, subjects must have TEWL of nonlesional skin of upper arm that is ≥ 8 gm/m2/h at screening visit. This is to ensure that we are in fact studying the subset of AD subjects who have a skin barrier defect.

You may not qualify if:

• Unwillingness or inability to complete the Informed Consent process
• Subjects with a history of keloid formation
• History of lidocaine or Novocain allergy
• Subjects with a systemic infection requiring a course of systemic antibiotics or antivirals within the last 2 weeks
• Subjects with MD diagnosed Type 1 or 2 diabetes mellitus
• Subjects with NYHA class III or IV cardiac status
• Subjects with a history of liver disease (EtOH, viral hepatitis, drug-induced hepatitis or other)
• Subjects with evidence of an underlying systemic disease based on history and physical (other than the above diagnostic categories (and associated allergic disorders), or well-controlled hypertension, or hyperlipidemia).
• History of cancer other than nonmelanomatous skin cancer or cervical dysplasia
• Participants enrolled while on a systemic treatment for their atopic dermatitis (e.g. cyclosporine, mycophenolate mofetil) must remain on a stable dose for the duration of the study

Sponsors & Collaborators

• University of Rochester: lead
• National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS): collaborator

Study Sites (1)

University of Rochester Medical Center

Rochester, New York, 14642, United States

Location

MeSH Terms

Conditions

Dermatitis, Atopic; Eczema

Interventions

Pioglitazone

Condition Hierarchy (Ancestors)

Skin Diseases, Genetic; Genetic Diseases, Inborn; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Dermatitis; Skin Diseases; Skin and Connective Tissue Diseases; Skin Diseases, Eczematous; Hypersensitivity, Immediate; Hypersensitivity; Immune System Diseases

Intervention Hierarchy (Ancestors)

Thiazolidinediones; Thiazoles; Sulfur Compounds; Organic Chemicals; Azoles; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds

Study Officials

• Lisa A Beck, MD

  University of Rochester

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor of Dermatology

Study Record Dates

• First Submitted: September 26, 2012
• First Posted: September 28, 2012
• Study Start: March 1, 2013
• Primary Completion: January 1, 2014
• Study Completion: June 1, 2014
• Last Updated: December 2, 2014

Record last verified: 2014-12

Locations

US (1)