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Topical NF-kappaB Decoy in the Treatment of Atopic Dermatitis

Primary Purpose

Atopic Dermatitis

Status
Completed
Phase
Phase 1
Locations
United States
Study Type
Interventional
Intervention
NF-kappaB Decoy
Sponsored by
Anesiva, Inc.
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional treatment trial for Atopic Dermatitis focused on measuring atopic dermatitis, eczema

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • University of Miami Skin Research
  • Minnesota Clinical Study Center
  • Mount Sinai School of Medicine
  • Helendale Dermatology & Medical Spa, LLP
  • Oregon Health & Science University, Department of Dermatology
  • Derm Research, Inc.
  • Center for Clinical Studies
  • Center for Clinical Studies
  • Madison Skin & Research, Inc.

Outcomes

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

Full Information

First Posted
July 28, 2005
Last Updated
November 18, 2008
Sponsor
Anesiva, Inc.
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1. Study Identification

Unique Protocol Identification Number
NCT00125333
Brief Title
Topical NF-kappaB Decoy in the Treatment of Atopic Dermatitis
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
Study Type
Interventional

2. Study Status

Record Verification Date
November 2008
Overall Recruitment Status
Completed
Study Start Date
March 2005 (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
November 2005 (undefined)

3. Sponsor/Collaborators

Name of the Sponsor
Anesiva, Inc.

4. Oversight

5. Study Description

Brief Summary
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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Atopic Dermatitis
Keywords
atopic dermatitis, eczema

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 1, Phase 2
Interventional Study Model
Parallel Assignment
Masking
Double
Allocation
Randomized
Enrollment
75 (false)

8. Arms, Groups, and Interventions

Intervention Type
Drug
Intervention Name(s)
NF-kappaB Decoy
Primary Outcome Measure Information:
Title
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 Measure Information:
Title
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
Title
To evaluate the systemic pharmacokinetic (PK) profile of NF-kappaB Decoy

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Andria Langenberg, MD
Organizational Affiliation
Anesiva, Inc.
Official's Role
Study Director
Facility Information:
Facility Name
University of Miami Skin Research
City
Miami
State/Province
Florida
ZIP/Postal Code
33136
Country
United States
Facility Name
Minnesota Clinical Study Center
City
Fridley
State/Province
Minnesota
ZIP/Postal Code
55432
Country
United States
Facility Name
Mount Sinai School of Medicine
City
New York
State/Province
New York
ZIP/Postal Code
10029
Country
United States
Facility Name
Helendale Dermatology & Medical Spa, LLP
City
Rochester
State/Province
New York
ZIP/Postal Code
14609
Country
United States
Facility Name
Oregon Health & Science University, Department of Dermatology
City
Portland
State/Province
Oregon
ZIP/Postal Code
97201
Country
United States
Facility Name
Derm Research, Inc.
City
Austin
State/Province
Texas
ZIP/Postal Code
78759
Country
United States
Facility Name
Center for Clinical Studies
City
Houston
State/Province
Texas
ZIP/Postal Code
77030
Country
United States
Facility Name
Center for Clinical Studies
City
South Houston
State/Province
Texas
ZIP/Postal Code
77058
Country
United States
Facility Name
Madison Skin & Research, Inc.
City
Madison
State/Province
Wisconsin
ZIP/Postal Code
53719
Country
United States

12. IPD Sharing Statement

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Topical NF-kappaB Decoy in the Treatment of Atopic Dermatitis

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