Working...
ClinicalTrials.gov
ClinicalTrials.gov Menu

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT02317276
Recruitment Status : Terminated (Unable to meet the study's recruitment goals)
First Posted : December 15, 2014
Results First Posted : January 24, 2019
Last Update Posted : January 24, 2019
Sponsor:
Collaborator:
Genentech, Inc.
Information provided by (Responsible Party):
University of California, San Francisco

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.

Condition or disease Intervention/treatment Phase
Dermatitis, Atopic Drug: Triamcinolone 0.1% Phase 4

Detailed Description:
This exploratory study consists of four visits to the investigator site post screening: at Weeks 0 (baseline), 2, 6 and 8 (Figure 1). At the first visit (baseline), patients who have met the screening eligibility criteria will be started on a stable TCS regimen for a total of two weeks. At the second visit (Week 2) following two weeks of therapy on stable TCS, patients will stop TCS and blood, serum, plasma and two 6mm punch biopsies (one lesional (L) and one non-lesional (NL) skin) will be obtained. At the third visit (Week 6), after four weeks receiving no TCS, the same sample collections will be repeated and the patients will then enter a two week safety follow up. At the end of the safety follow up (last visit, Week 8) and after obtaining written informed consent by the patient, blood, serum and plasma samples mav be collected.

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 11 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Masking Description: Open label
Primary Purpose: Treatment
Official Title: A Study in Atopic Dermatitis to Determine Serum and Skin Biopsy Biomarkers in Patients Receiving Topical Corticosteroid (TCS) and Following TCS Withdrawal
Study Start Date : December 2014
Actual Primary Completion Date : April 6, 2017
Actual Study Completion Date : April 6, 2017


Arm Intervention/treatment
Experimental: Treatment
Topical Triamcinolone 0.1% ointment will be provided for twice daily application, during treatment periods.
Drug: Triamcinolone 0.1%
Topical ointment
Other Name: Triamcinolone 0.1% ointment




Primary Outcome Measures :
  1. Change in Blood and Tissue Levels of Biomarkers Following Treatment of Atopic Dermatitis With Topical Corticosteroids. [ Time Frame: Baseline to Week 8 ]
    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.



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   18 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. Male or female patients 18-75 years of age
  2. AD diagnosed by the Rajka/Hanifin criteria at the time of screening and that has been present for at least 1 year
  3. 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
  4. Eczema Area and Severity Index (EASI) score ≥ 14 at the screening and baseline visits
  5. Investigator's Global Assessment (IGA; 5-point) score ≥ 3 at the screening and baseline visits
  6. ≥10% body surface area involvement by AD
  7. 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

Exclusion Criteria:

  1. Evidence of other concomitant skin conditions (e.g., psoriasis or contact dermatitis)
  2. Use of topical calcineurin inhibitors within 4 weeks of screening
  3. Hypersensitivity to TCS or to any other ingredients contained by the emollient or TCS product used during the study
  4. Evidence of active skin infection at screening or baseline visit
  5. Evidence or history of active or latent infections such as tuberculosis or hepatitis C
  6. Patient clinical condition is not appropriate for treatment with protocol prescribed TCS
  7. Use of an investigational agent within 4 weeks prior to screening or within 5 half-lives of the investigational agent, whichever is longer
  8. Use of a tanning booth/parlor within 4 weeks before the baseline visit
  9. Use of any anti-histamine medication within 4 weeks before the baseline visit.
  10. History of any condition (e.g. bleeding diathesis) that may predispose the patient to complications associated with the planned skin biopsy procedures
  11. Known current malignancy or current evaluation for a potential malignancy, including basal or squamous cell carcinoma of the skin or carcinoma in situ
  12. 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
  13. Unwillingness or inability to comply with the study protocol for any other reason.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02317276


Locations
Layout table for location information
United States, California
UCSF Dermatology
San Francisco, California, United States, 94115
Sponsors and Collaborators
University of California, San Francisco
Genentech, Inc.
Investigators
Layout table for investigator information
Principal Investigator: Sarah Arron, MD, PhD University of California, San Francisco
  Study Documents (Full-Text)

Documents provided by University of California, San Francisco:

Publications of Results:

Layout table for additonal information
Responsible Party: University of California, San Francisco
ClinicalTrials.gov Identifier: NCT02317276     History of Changes
Other Study ID Numbers: GNE AD 431
First Posted: December 15, 2014    Key Record Dates
Results First Posted: January 24, 2019
Last Update Posted: January 24, 2019
Last Verified: January 2019

Additional relevant MeSH terms:
Layout table for MeSH terms
Dermatitis
Dermatitis, Atopic
Skin Diseases
Skin Diseases, Genetic
Genetic Diseases, Inborn
Skin Diseases, Eczematous
Hypersensitivity, Immediate
Hypersensitivity
Immune System Diseases
Triamcinolone
Triamcinolone Acetonide
Triamcinolone hexacetonide
Triamcinolone diacetate
Anti-Inflammatory Agents
Glucocorticoids
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs
Immunosuppressive Agents
Immunologic Factors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action