Topical NF-kappaB Decoy in the Treatment of Atopic Dermatitis

This study has been completed.
Sponsor:
Information provided by:
Anesiva, Inc.
ClinicalTrials.gov Identifier:
NCT00125333
First received: July 28, 2005
Last updated: November 18, 2008
Last verified: November 2008
  Purpose

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 1
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double-Blind
Primary Purpose: Treatment
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

Resource links provided by NLM:


Further study details as provided by Anesiva, Inc.:

Primary Outcome Measures:
  • 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

Secondary Outcome Measures:
  • 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
  • To evaluate the systemic pharmacokinetic (PK) profile of NF-kappaB Decoy

Estimated Enrollment: 75
Study Start Date: March 2005
Estimated Study Completion Date: November 2005
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.

  Eligibility

Ages Eligible for Study:   18 Years to 65 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
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, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00125333

Locations
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
Mount Sinai School of Medicine
New York, New York, United States, 10029
Helendale Dermatology & Medical Spa, LLP
Rochester, New York, United States, 14609
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
Sponsors and Collaborators
Anesiva, Inc.
Investigators
Study Director: Andria Langenberg, MD Anesiva, Inc.
  More Information

No publications provided

Responsible Party: Shaun Comfort, MD, Anesiva, Inc.
ClinicalTrials.gov Identifier: NCT00125333     History of Changes
Other Study ID Numbers: 110-01P
Study First Received: July 28, 2005
Last Updated: November 18, 2008
Health Authority: United States: Food and Drug Administration

Keywords provided by Anesiva, Inc.:
atopic dermatitis, eczema

Additional relevant MeSH terms:
Dermatitis
Dermatitis, Atopic
Skin Diseases
Skin Diseases, Genetic
Genetic Diseases, Inborn
Skin Diseases, Eczematous
Hypersensitivity, Immediate
Hypersensitivity
Immune System Diseases
Carisoprodol
Muscle Relaxants, Central
Physiological Effects of Drugs
Pharmacologic Actions
Neuromuscular Agents
Peripheral Nervous System Agents
Central Nervous System Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on July 24, 2014