Topical NF-kappaB Decoy in the Treatment of Atopic Dermatitis
NCT ID: NCT00125333
Last Updated: 2008-11-19
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
COMPLETED
PHASE1/PHASE2
75 participants
INTERVENTIONAL
2005-03-31
2005-11-30
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
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.
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Keywords
Explore important study keywords that can help with search, categorization, and topic discovery.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
RANDOMIZED
PARALLEL
TREATMENT
DOUBLE
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
NF-kappaB Decoy
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
* 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 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
18 Years
65 Years
ALL
No
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
Anesiva, Inc.
INDUSTRY
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Anesiva, Inc.
Principal Investigators
Learn about the lead researchers overseeing the trial and their institutional affiliations.
Andria Langenberg, MD
Role: STUDY_DIRECTOR
Anesiva, Inc.
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
University of Miami Skin Research
Miami, Florida, United States
Minnesota Clinical Study Center
Fridley, Minnesota, United States
Mount Sinai School of Medicine
New York, New York, United States
Helendale Dermatology & Medical Spa, LLP
Rochester, New York, United States
Oregon Health & Science University, Department of Dermatology
Portland, Oregon, United States
Derm Research, Inc.
Austin, Texas, United States
Center for Clinical Studies
Houston, Texas, United States
Center for Clinical Studies
South Houston, Texas, United States
Madison Skin & Research, Inc.
Madison, Wisconsin, United States
Countries
Review the countries where the study has at least one active or historical site.
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
110-01P
Identifier Type: -
Identifier Source: org_study_id