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Sponsored by: |
Anesiva, Inc. |
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Information provided by: | Anesiva, Inc. |
ClinicalTrials.gov Identifier: | NCT00125333 |
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.
Condition | Intervention | Phase |
---|---|---|
Atopic Dermatitis |
Drug: NF-kappaB Decoy |
Phase I Phase II |
Study Type: | Interventional |
Study Design: | Treatment, Randomized, Double-Blind, Placebo Control, Parallel Assignment, Safety/Efficacy Study |
Official Title: | 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 |
Estimated Enrollment: | 75 |
Study Start Date: | March 2005 |
Estimated Study Completion Date: | November 2005 |
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.
Ages Eligible for Study: | 18 Years to 65 Years |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
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);
Exclusion Criteria:
United States, Florida | |
University of Miami Skin Research | |
Miami, Florida, United States, 33136 | |
United States, Minnesota | |
Minnesota Clinical Study Center | |
Fridley, Minnesota, United States, 55432 | |
United States, New York | |
Helendale Dermatology & Medical Spa, LLP | |
Rochester, New York, United States, 14609 | |
Mount Sinai School of Medicine | |
New York, New York, United States, 10029 | |
United States, Oregon | |
Oregon Health & Science University, Department of Dermatology | |
Portland, Oregon, United States, 97201 | |
United States, Texas | |
Derm Research, Inc. | |
Austin, Texas, United States, 78759 | |
Center for Clinical Studies | |
Houston, Texas, United States, 77030 | |
Center for Clinical Studies | |
South Houston, Texas, United States, 77058 | |
United States, Wisconsin | |
Madison Skin & Research, Inc. | |
Madison, Wisconsin, United States, 53719 |
Study Director: | Andria Langenberg, MD | Anesiva, Inc. |
Responsible Party: | Anesiva, Inc. ( Shaun Comfort, MD ) |
Study ID Numbers: | 110-01P |
Study First Received: | July 28, 2005 |
Last Updated: | November 18, 2008 |
ClinicalTrials.gov Identifier: | NCT00125333 History of Changes |
Health Authority: | United States: Food and Drug Administration |
atopic dermatitis, eczema |
Carisoprodol Hypersensitivity Dermatitis, Atopic Genetic Diseases, Inborn Skin Diseases Muscle Relaxants, Central |
Hypersensitivity, Immediate Skin Diseases, Eczematous Peripheral Nervous System Agents Eczema Skin Diseases, Genetic Dermatitis |
Carisoprodol Dermatitis, Atopic Skin Diseases Immune System Diseases Physiological Effects of Drugs Neuromuscular Agents Pharmacologic Actions Hypersensitivity Genetic Diseases, Inborn |
Therapeutic Uses Muscle Relaxants, Central Hypersensitivity, Immediate Skin Diseases, Eczematous Peripheral Nervous System Agents Central Nervous System Agents Skin Diseases, Genetic Dermatitis |