Topical NF-kappaB Decoy in the Treatment of Atopic Dermatitis

Completed · Phase 1/Phase 2

Conditions studied: Atopic Dermatitis

In brief

The purpose of this study is to determine whether this topical NF-kappaB Decoy candidate is safe in persons with atopic dermatitis. Preliminary evidence of efficacy (whether it is working) will also be evaluated.

Key facts

Study ID: NCT00125333
Run by: Anesiva, Inc.
People needed: 75
Starts: 2005-03-01
Expected to finish: 2005-11-01
Last updated by the study team: 2008-11-19

Who can join

Age: 18 and older, up to 65. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

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

You may not qualify if…

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

Where it is running

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

Full record on ClinicalTrials.gov

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