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

NCT ID: NCT01695707

Last Updated: 2014-12-02

Basic Information

• Recruitment Status: WITHDRAWN
• Clinical Phase: NA
• Study Classification: INTERVENTIONAL
• Study Start Date: 2013-03-31
• Study Completion Date: 2014-06-30

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.

Detailed Description

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.

Conditions

Atopic Dermatitis

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: QUADRUPLE

Study Groups

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.

Group Type: PLACEBO_COMPARATOR

Placebo (for pioglitazone)

Intervention Type: DRUG

see Arm Description

Pioglitazone

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.

Group Type: EXPERIMENTAL

Pioglitazone

Intervention Type: DRUG

see Arm Description

Interventions

Pioglitazone

see Arm Description

Intervention Type: DRUG

Placebo (for pioglitazone)

see Arm Description

Intervention Type: DRUG

Other Intervention Names

Actos

Eligibility Criteria

Inclusion Criteria

• 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.

Exclusion Criteria

• 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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 55 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS)

NIH

Sponsor Role: collaborator

University of Rochester

OTHER

Sponsor Role: lead

Responsible Party

Lisa Beck

Professor of Dermatology

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Lisa A Beck, MD

Role: PRINCIPAL_INVESTIGATOR

University of Rochester

Locations

University of Rochester Medical Center

Rochester, New York, United States

Countries

United States

Other Identifiers

1R21AR062357

Identifier Type: NIH

Identifier Source: secondary_id

View Link

RSRB00041078

Identifier Type: -

Identifier Source: org_study_id