Reversal of Epidermal Phenotype in Severe Atopic Dermatitis With Cyclosporine Therapy

NCT01149759 | Completed Results

• 1 other identifier: JKR-0663
• Study Type: interventional
• Target: 9
• Locations: 1 country
• Sites: 1

Brief Summary

Atopic Dermatitis (AD) or eczema is a chronic relapsing inflammatory disease that affects 1-3% of the adults and up to 25% of the children in the United States. Patients with severe AD will be studied during a 24-week study with systemic cyclosporine (Neoral, capsule form) to evaluate the immune suppression and pathological correlation of cyclosporine A in these patients in order to determine the extent to which immune activation drives the pathological epidermal phenotype.

Conditions

Atopic Dermatitis; Eczema

Keywords

Atopic Dermatitis; Eczema

Outcome Measures

Primary Outcomes (1)

• SCORAD Change Score

  SCORAD ("SCORing Atopic Dermatitis") is a clinical tool for assessing the severity (i.e., extent, intensity) of atopic dermatitis (AD) as objectively as possible with scores ranging from 0-100. The higher the score indicates more severe AD. For this outcome the SCORAD change score is computed as an absolute number which is comparing improvement in the SCORAD score of participants at week 12 compared to their SCORAD score at baseline.

  12 weeks

Secondary Outcomes (1)

• Change in Epidermal Thickness

  12 weeks

Study Arms (1)

Cyclosporine A

EXPERIMENTAL

5 mg/kg for first 4 weeks, followed by tapering to 1 mg/kg for 12 weeks until discontinuation at 16 weeks.

Drug: Cyclosporine A

Interventions

Cyclosporine A DRUG

5 mg/kg for first 4 weeks, followed by tapering to 1 mg/kg for 12 weeks until discontinuation at 16 weeks

Also known as: Neoral

Cyclosporine A

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Severe AD (defined as having a mean SCORAD score\> 40,, with significant disease activity, pruritus, and sleep disturbances (13), suitable for treatment with Cyclosporine, and have failed or unsuitable for other treatment modalities, including topical and or systemic steroids or phototherapy. Patients must also have an IGA score of 3 or greater,
• Males and females age 18 and above (if females are of child-bearing potential they must agree to use acceptable contraception during the study).
• No systemic treatment contraception must commence 2 weeks prior to initiating the drug.
• No systemic treatment for 4 weeks, no topical treatment or phototherapy for 2 weeks

You may not qualify if:

• Previously treated with cyclosporine and had unacceptable toxicity
• Past or current history of malignancy (except for treated isolated skin cancers)
• Renal, hepatic, and hematologic laboratory values greater than CTC grade 1 toxicity, such as but not limited to creatinine \>1.5 ULN, SGOT\>2.5 ULN. Values greater then grade 1 would most likely represent clinically significant renal, hepatic or hematologic disease
• Stage I hypertension is defined as \>140/90. Patients with this blood pressure or higher on two separate occasions, whether on medications or not, will be excluded (JNC guidelines www.nhlbi.nih.gov/guidelines/hypertension )
• Significant lipid panel abnormality (any grade 1 toxicity on CTC scale)
• Lactating females
• Other medical condition that would increase the risk of cyclosporine toxicity
• Positive PPD
• Primary or secondary immune deficiency (including known HIV status)
• Possible or known pregnancy
• Serious infection (such as active hepatitis)
• Drug or alcohol abuse
• Inability or lack of willingness to co-operate with regular monitoring
• Severe photodamage/precancerous skin lesions due to previous sunlight exposure, or photo/photochemotherapy
• Concurrent use of PUVA or UVB, other radiation therapy,

Sponsors & Collaborators

• Rockefeller University: lead

Study Sites (1)

The Rockefeller University

New York, New York, 10065, United States

Location

MeSH Terms

Conditions

Dermatitis, Atopic; Eczema

Interventions

Cyclosporine

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)

Cyclosporins; Peptides, Cyclic; Macrocyclic Compounds; Polycyclic Compounds; Peptides; Amino Acids, Peptides, and Proteins

Results Point of Contact

• Title: Emma Guttman Yassky, MD
• Organization: Rockefeller University

skhattri@rockefeller.edu

212-327-8333

Study Officials

• James Krueger, MD, PhD

  The Rockefeller University

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Research Nurse Practictioner

Study Record Dates

• First Submitted: June 22, 2010
• First Posted: June 23, 2010
• Study Start: June 1, 2010
• Primary Completion: December 1, 2014
• Study Completion: December 1, 2014
• Last Updated: March 27, 2017
• Results First Posted: March 27, 2017

Record last verified: 2017-02

Locations

US (1)