- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00125333
Topical NF-kappaB Decoy in the Treatment of Atopic Dermatitis
A Phase 1/2 Multicenter, Randomized, Double-Blind, Placebo-Controlled, Parallel-Group, Dose-Ranging Study to Evaluate the Safety of Repeated Topical Application of Three Concentrations of NF-kappaB Decoy in Adults With Mild-to-Moderate Atopic Dermatitis
Study Overview
Detailed Description
This is a randomized, double-blind, placebo-controlled, parallel-group, dose-ranging study to evaluate the safety of repeated application of three concentrations of NF-kappaB Decoy in approximately 75 subjects with mild-to-moderate atopic dermatitis. The face, hands, feet, scalp, or groin may NOT be treated.
Other treatment agents are currently available for atopic dermatitis but present significant potential side effects (topical steroids) or are potent immunosuppressives (topical calcineurin inhibitors) with pending longer-term safety data.
NF-kappaB Decoy is a double-stranded deoxyribonucleic acid (DNA) oligodeoxynucleotide that mimics the NF-kappaB binding sequence on the chromosomal DNA, thereby inhibiting the production of the inflammatory response triggered by NF-kappaB. This mechanism of action presents a unique treatment modality.
A comprehensive series of nonclinical data have produced promising results.
Study Type
Enrollment
Phase
- Phase 2
- Phase 1
Contacts and Locations
Study Locations
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Florida
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Miami, Florida, United States, 33136
- University of Miami Skin Research
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Minnesota
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Fridley, Minnesota, United States, 55432
- Minnesota Clinical Study Center
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New York
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New York, New York, United States, 10029
- Mount Sinai School of Medicine
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Rochester, New York, United States, 14609
- Helendale Dermatology & Medical Spa, LLP
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Oregon
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Portland, Oregon, United States, 97201
- Oregon Health & Science University, Department of Dermatology
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Texas
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Austin, Texas, United States, 78759
- Derm Research, Inc.
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Houston, Texas, United States, 77030
- Center for Clinical Studies
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South Houston, Texas, United States, 77058
- Center for Clinical Studies
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Wisconsin
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Madison, Wisconsin, United States, 53719
- Madison Skin & Research, Inc.
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- Are 18 through 65 years of age and sign an informed consent
- Have been given a diagnosis of mild to moderate atopic dermatitis as defined by: *Pruritus; *Eczematous dermatitis (acute, subacute, chronic) involving at least current or prior flexural lesions with chronic or relapsing course; *Early age of onset (prior to 10 years of age, by history); *Personal or family history of atopy
- If receiving antihistamines, are on a stabilized dose, and expect to maintain this dose throughout the study
- Are females or males of reproductive potential who are compliant in using adequate birth control or are females or males not of reproductive potential
Exclusion Criteria:
- Have concomitant dermatologic or medical condition(s) which may interfere with the investigator's ability to evaluate the subject's response to the study drug
- Have immunocompromised status (such as known human immunodeficiency virus infection)
- Have any clinically significant abnormal clinical laboratory test results at Screening
- Have a history of malignancy not in remission for at least 5 years excluding basal cell carcinoma and nonperiorificial squamous cell carcinoma of the skin
- Have an active intercurrent infection
- Have applied any topical medication (including corticosteroid, calcineurin inhibitor, topical H1 and H2 antihistamines, topical antimicrobials, other medicated topical agents) or herbal preparation to the area selected for treatment within 1 week of the Day 1 visit; have used any systemic antibiotic within 1 week prior to the Day 1 visit; have used any systemic treatment for atopic dermatitis (including systemic corticosteroids, nonsteroidal immunosuppressants, or treatment with light) within 4 weeks prior to the Day 1 visit; have used an investigational drug for any reason within 4 weeks of the Day 1 visit; have used intranasal and/or inhaled corticosteroids at doses > 2 mg prednisone or equivalent per day within 4 weeks of the Day 1 visit; or have used immunosuppressive or immunomodulating drugs such as etanercept, alefacept, or infliximab within 16 weeks prior to Day 1
- Have a history of hypersensitivity or allergic reactions to parabens or any other ingredient in the vehicle formulation
- If female, are pregnant or lactating, or intend to become pregnant during the study period
- If male, have a female partner who is pregnant or lactating, or intends to become pregnant during the study period
- Have any reason which, in the opinion of the investigator, interferes with the ability of the subject to participate in or complete the trial, or which places the subject at undue risk
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Double
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
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To evaluate the safety and tolerability of twice-daily topical application of three concentrations of NF-kappaB Decoy in adult subjects with mild-to-moderate atopic dermatitis
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Secondary Outcome Measures
Outcome Measure |
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To make a preliminary evaluation of the efficacy of the topical NF-kappaB Decoy in the treatment of mild-to-moderate atopic dermatitis in adult subjects
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To evaluate the systemic pharmacokinetic (PK) profile of NF-kappaB Decoy
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Collaborators and Investigators
Sponsor
Investigators
- Study Director: Andria Langenberg, MD, Anesiva, Inc.
Study record dates
Study Major Dates
Study Start
Study Completion
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- 110-01P
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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