A Study to Determine Serum and Skin Biopsy Biomarkers in Patients Receiving Topical Corticosteroid (TCS) and Following TCS Withdrawal

NCT02317276 | Terminated Phase 4 Results

• 1 other identifier: GNE AD 431
• Study Type: interventional
• Target: 11
• Locations: 1 country
• Sites: 1

Brief Summary

The purpose of this study is to assess the differential expression of AD biomarkers in serum, plasma, and skin biopsies from both lesional and non-lesional skin in moderate to severe AD patients in the presence of TCS and after withdrawal from TCS.

Conditions

Dermatitis, Atopic

Outcome Measures

Primary Outcomes (1)

• Change in Blood and Tissue Levels of Biomarkers Following Treatment of Atopic Dermatitis With Topical Corticosteroids.

  The blood and skin biomarkers to be evaluated include but are not limited to eosinophils, Immunoglobulin E (IgE), Interleukin 13 (IL-13), Chemokine ligand 13 (CCL-13), and Chemokine ligand 17 (CCL-17). These biomarkers will be evaluated for differential gene expression and protein levels in samples obtained from atopic dermatitis patients on and off topical corticosteroid treatment.

  Baseline to Week 8

Study Arms (1)

Treatment

EXPERIMENTAL

Topical Triamcinolone 0.1% ointment will be provided for twice daily application, during treatment periods.

Drug: Triamcinolone 0.1%

Interventions

Triamcinolone 0.1% DRUG

Topical ointment

Also known as: Triamcinolone 0.1% ointment

Treatment

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Male or female patients 18-75 years of age
• AD diagnosed by the Rajka/Hanifin criteria at the time of screening and that has been present for at least 1 year
• History of inadequate response to a stable regimen of TCS for 1 month (in the 3 months immediately preceding the screening visit) as treatment for their AD
• Eczema Area and Severity Index (EASI) score ≥ 14 at the screening and baseline visits
• Investigator's Global Assessment (IGA; 5-point) score ≥ 3 at the screening and baseline visits
• ≥10% body surface area involvement by AD
• A washout period prior to screening for those patients who have previously received the following medications:
• Cyclosporine/Oral Steroids/Imuran/Mycophenolate Mofetil/Other systemic immunosuppressants: 4 weeks
• Phototherapy: 4 weeks
• Biologics: 5 half lives of the drug

You may not qualify if:

• Evidence of other concomitant skin conditions (e.g., psoriasis or contact dermatitis)
• Use of topical calcineurin inhibitors within 4 weeks of screening
• Hypersensitivity to TCS or to any other ingredients contained by the emollient or TCS product used during the study
• Evidence of active skin infection at screening or baseline visit
• Evidence or history of active or latent infections such as tuberculosis or hepatitis C
• Patient clinical condition is not appropriate for treatment with protocol prescribed TCS
• Use of an investigational agent within 4 weeks prior to screening or within 5 half-lives of the investigational agent, whichever is longer
• Use of a tanning booth/parlor within 4 weeks before the baseline visit
• Use of any anti-histamine medication within 4 weeks before the baseline visit.
• History of any condition (e.g. bleeding diathesis) that may predispose the patient to complications associated with the planned skin biopsy procedures
• Known current malignancy or current evaluation for a potential malignancy, including basal or squamous cell carcinoma of the skin or carcinoma in situ
• Other clinically significant medical disease that is uncontrolled despite treatment that is likely, in the opinion of the investigator, to impact the patient's ability to participate in the study or to impact the study pharmacodynamic (PD), or safety assessments
• Unwillingness or inability to comply with the study protocol for any other reason.

Sponsors & Collaborators

• University of California, San Francisco: lead
• Genentech, Inc.: collaborator

Study Sites (1)

UCSF Dermatology

San Francisco, California, 94115, United States

Location

Related Publications (7)

• Bieber T. Atopic dermatitis. N Engl J Med. 2008 Apr 3;358(14):1483-94. doi: 10.1056/NEJMra074081. No abstract available.

  PMID: 18385500 RESULT

• Williams DL, Ozment-Skelton T, Li C. Modulation of the phosphoinositide 3-kinase signaling pathway alters host response to sepsis, inflammation, and ischemia/reperfusion injury. Shock. 2006 May;25(5):432-9. doi: 10.1097/01.shk.0000209542.76305.55.

  PMID: 16680006 RESULT

• Simpson EL. Atopic dermatitis: a review of topical treatment options. Curr Med Res Opin. 2010 Mar;26(3):633-40. doi: 10.1185/03007990903512156.

  PMID: 20070141 RESULT

• Ring J, Alomar A, Bieber T, Deleuran M, Fink-Wagner A, Gelmetti C, Gieler U, Lipozencic J, Luger T, Oranje AP, Schafer T, Schwennesen T, Seidenari S, Simon D, Stander S, Stingl G, Szalai S, Szepietowski JC, Taieb A, Werfel T, Wollenberg A, Darsow U; European Dermatology Forum (EDF); European Academy of Dermatology and Venereology (EADV); European Federation of Allergy (EFA); European Task Force on Atopic Dermatitis (ETFAD); European Society of Pediatric Dermatology (ESPD); Global Allergy and Asthma European Network (GA2LEN). Guidelines for treatment of atopic eczema (atopic dermatitis) part I. J Eur Acad Dermatol Venereol. 2012 Aug;26(8):1045-60. doi: 10.1111/j.1468-3083.2012.04635.x.

  PMID: 22805051 RESULT

• Schneider L, Tilles S, Lio P, Boguniewicz M, Beck L, LeBovidge J, Novak N, Bernstein D, Blessing-Moore J, Khan D, Lang D, Nicklas R, Oppenheimer J, Portnoy J, Randolph C, Schuller D, Spector S, Tilles S, Wallace D. Atopic dermatitis: a practice parameter update 2012. J Allergy Clin Immunol. 2013 Feb;131(2):295-9.e1-27. doi: 10.1016/j.jaci.2012.12.672.

  PMID: 23374261 RESULT

• Gittler JK, Shemer A, Suarez-Farinas M, Fuentes-Duculan J, Gulewicz KJ, Wang CQ, Mitsui H, Cardinale I, de Guzman Strong C, Krueger JG, Guttman-Yassky E. Progressive activation of T(H)2/T(H)22 cytokines and selective epidermal proteins characterizes acute and chronic atopic dermatitis. J Allergy Clin Immunol. 2012 Dec;130(6):1344-54. doi: 10.1016/j.jaci.2012.07.012. Epub 2012 Aug 27.

  PMID: 22951056 RESULT

• Choy DF, Hsu DK, Seshasayee D, Fung MA, Modrusan Z, Martin F, Liu FT, Arron JR. Comparative transcriptomic analyses of atopic dermatitis and psoriasis reveal shared neutrophilic inflammation. J Allergy Clin Immunol. 2012 Dec;130(6):1335-43.e5. doi: 10.1016/j.jaci.2012.06.044. Epub 2012 Aug 22.

  PMID: 22920495 RESULT

MeSH Terms

Conditions

Dermatitis, Atopic

Interventions

Triamcinolone; Ointments

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)

Pregnadienes; Pregnanes; Steroids; Fused-Ring Compounds; Polycyclic Compounds; Steroids, Fluorinated; Dosage Forms; Pharmaceutical Preparations

Limitations and Caveats

Due to our inability to meet the sponsor's recruitment goals, the study was terminated and no data was analyzed.

Results Point of Contact

• Title: Sarah Arron, MD, PhD
• Organization: UCSF Dermatology

Sarah.Arron@ucsf.edu

415-353-9684

Study Officials

• Sarah Arron, MD, PhD

  University of California, San Francisco

  PRINCIPAL INVESTIGATOR

Publication Agreements

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

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: NA
• Masking: NONE
• Masking Details: Open label
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 3, 2014
• First Posted: December 15, 2014
• Study Start: December 1, 2014
• Primary Completion: April 6, 2017
• Study Completion: April 6, 2017
• Last Updated: January 24, 2019
• Results First Posted: January 24, 2019

Record last verified: 2019-01

Locations

US (1)