Vehicle Controlled Efficacy and Safety Study of Two Dose Regimens of CD07223 1.5% Topical Gel in Impetigo
Primary Purpose
Impetigo
Status
Completed
Phase
Phase 2
Locations
International
Study Type
Interventional
Intervention
Experimental: CD07223 1.5 % Topical Gel BID
Experimental: CD07223 1.5% Topical Gel TID
Placebo Comparator: CD07223 vehicle gel BID
Placebo Comparator: CD07223 vehicle gel TID
Sponsored by
About this trial
This is an interventional treatment trial for Impetigo
Eligibility Criteria
Inclusion Criteria:
- Male or female 2 years of age or older
- Clinical diagnosis of primary impetigo (bullous or non bullous)
- Minimum diameter of Target Lesion to be one centimeter measured either as length or width.
- Presence of at least one and no more than ten lesions per subject at the time of screening
- The infected lesions' total area (as determined by the Investigator) must be less than 100 cm2 in total area for subjects 18 years of age or older, or up to a maximum of 2% total body surface area for subjects younger than 18 years of age.
- Skin Infection Rating Scale (SIRS) total score of the Target Lesion of at least 4
Exclusion Criteria:
- Presence of other active skin diseases at or near the Target Lesion area to be treated
- A subject whose disease is so widespread or severe that, in the opinion of the investigator, oral antibiotic treatment is needed
- Signs and symptoms of another current infection requiring antibiotic treatment
- Tympanic temperature at Screening/Baseline exceeding 38 degrees Celsius (100.4 degrees Fahrenheit) in a pediatric subject or 37.8 degrees Celsius (100 degrees Fahrenheit) in an adult subject
- History of Hepatitis B or C, HIV/ AIDS, or other immunodeficiency disease
- Concurrent or recent scabies infection or lice infestation (pediculosis) of the scalp
- Use of systemic antibiotics or systemic steroids within 14 days prior to study entry. A history of three or more courses of systemic antibiotics within the 3 month period immediately prior to screening will also be considered exclusionary
- Use of topical antibiotics, topical antibacterials, topical antifungals or topical steroids within 14 days prior to study entry on any skin lesion (as deemed significant by the Investigator by virtue of the lesion's nature and/or position to impact on the effectiveness of the study drug)
- Participation in any other clinical study or use of any investigational drugs or investigational device within 30 days prior to enrollment
- Presence of secondarily infected traumatic lesions (e.g. surgical wounds, animal/insect bites, burns, lacerations and abrasions).
- Another family member in same household currently enrolled in this study or another family member in the same household with active impetigo
Sites / Locations
- SRCR, Inc
- Skin Care research Inc
- Eastern Research, Inc
- Cyn3rgy Research
- Cheraw Pediatrics, P.A.
- Integrity Clinical Research, Inc
- Sealy Urgent Care Center
- Langeberg Clinical Trials
- Newtown Clinical Research
- Phelang Research Center
- Setshaba Research Center
- Welkom Clinical Trial Center
- Synopsis Research
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm 4
Arm Type
Experimental
Experimental
Placebo Comparator
Placebo Comparator
Arm Label
CD07223 1.5 % Topical Gel BID
CD07223 1.5% Topical Gel TID
CD07223 vehicle gel BID
CD07223 vehicle gel TID
Arm Description
Drug: 1.5% CD07223 Topical Gel applied BID for 7 days
Drug: 1.5% CD07223 Topical Gel applied TID for 7 days
Drug: CD07223 Vehicle Topical Gel applied BID for 7 days
Drug: CD07223 Vehicle Topical Gel applied TID for 7 days
Outcomes
Primary Outcome Measures
Clinical Success at Follow up (Day 15) in the intent-to-treat (ITTC) population
Clinical Success is defined by the SIRS score of the Target Lesion
Secondary Outcome Measures
Full Information
NCT ID
NCT01670032
First Posted
August 17, 2012
Last Updated
August 8, 2014
Sponsor
NovaBay Pharmaceuticals, Inc.
1. Study Identification
Unique Protocol Identification Number
NCT01670032
Brief Title
Vehicle Controlled Efficacy and Safety Study of Two Dose Regimens of CD07223 1.5% Topical Gel in Impetigo
Official Title
A Multicenter, Double Blind, Randomized, Vehicle Controlled Study to Evaluate the Efficacy and Safety of Two Dose Regimens of CD 07223 1.5% Topical Gel in Impetigo
Study Type
Interventional
2. Study Status
Record Verification Date
August 2014
Overall Recruitment Status
Completed
Study Start Date
August 2012 (undefined)
Primary Completion Date
August 2013 (Actual)
Study Completion Date
August 2013 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
NovaBay Pharmaceuticals, Inc.
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief Summary
This study will be a multicenter, randomized, vehicle controlled, parallel, group, double blind study. Eligible subjects with a clinical diagnosis of impetigo will be randomized to one of four treatment groups: 1.5% CD07223 Topical Gel applied BID; 1.5% CD07223 Topical Gel applied TID; Vehicle Topical Gel applied BID;Vehicle Topical Gel applied TID. All treatments will be administered for 7 days. Disease activity for the Target Lesion will be evaluated using the Skin Infection Rating Scale (SIRS) Score.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Impetigo
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2, Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
328 (Actual)
8. Arms, Groups, and Interventions
Arm Title
CD07223 1.5 % Topical Gel BID
Arm Type
Experimental
Arm Description
Drug: 1.5% CD07223 Topical Gel applied BID for 7 days
Arm Title
CD07223 1.5% Topical Gel TID
Arm Type
Experimental
Arm Description
Drug: 1.5% CD07223 Topical Gel applied TID for 7 days
Arm Title
CD07223 vehicle gel BID
Arm Type
Placebo Comparator
Arm Description
Drug: CD07223 Vehicle Topical Gel applied BID for 7 days
Arm Title
CD07223 vehicle gel TID
Arm Type
Placebo Comparator
Arm Description
Drug: CD07223 Vehicle Topical Gel applied TID for 7 days
Intervention Type
Drug
Intervention Name(s)
Experimental: CD07223 1.5 % Topical Gel BID
Intervention Description
Eligible subjects are to apply study medication twice a day (BID) for seven days. All lesions will be treated with study medication. Scheduled study visits will occur at Day 1, Day 3, Day 8 and Day 15
Intervention Type
Drug
Intervention Name(s)
Experimental: CD07223 1.5% Topical Gel TID
Intervention Description
Eligible subjects are to apply study medication three times a day (TID) for seven days. All lesions will be treated with study medication. Scheduled study visits will occur at Day 1, Day 3, Day 8 and Day 15
Intervention Type
Drug
Intervention Name(s)
Placebo Comparator: CD07223 vehicle gel BID
Intervention Description
Eligible subjects are to apply study medication twice a day (BID) for seven days. All lesions will be treated with study medication. Scheduled study visits will occur at Day 1, Day 3, Day 8 and Day 15
Intervention Type
Drug
Intervention Name(s)
Placebo Comparator: CD07223 vehicle gel TID
Intervention Description
Eligible subjects are to apply study medication three times a day (TID) for seven days. All lesions will be treated with study medication. Scheduled study visits will occur at Day 1, Day 3, Day 8 and Day 15
Primary Outcome Measure Information:
Title
Clinical Success at Follow up (Day 15) in the intent-to-treat (ITTC) population
Description
Clinical Success is defined by the SIRS score of the Target Lesion
Time Frame
2 weeks
10. Eligibility
Sex
All
Minimum Age & Unit of Time
2 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Male or female 2 years of age or older
Clinical diagnosis of primary impetigo (bullous or non bullous)
Minimum diameter of Target Lesion to be one centimeter measured either as length or width.
Presence of at least one and no more than ten lesions per subject at the time of screening
The infected lesions' total area (as determined by the Investigator) must be less than 100 cm2 in total area for subjects 18 years of age or older, or up to a maximum of 2% total body surface area for subjects younger than 18 years of age.
Skin Infection Rating Scale (SIRS) total score of the Target Lesion of at least 4
Exclusion Criteria:
Presence of other active skin diseases at or near the Target Lesion area to be treated
A subject whose disease is so widespread or severe that, in the opinion of the investigator, oral antibiotic treatment is needed
Signs and symptoms of another current infection requiring antibiotic treatment
Tympanic temperature at Screening/Baseline exceeding 38 degrees Celsius (100.4 degrees Fahrenheit) in a pediatric subject or 37.8 degrees Celsius (100 degrees Fahrenheit) in an adult subject
History of Hepatitis B or C, HIV/ AIDS, or other immunodeficiency disease
Concurrent or recent scabies infection or lice infestation (pediculosis) of the scalp
Use of systemic antibiotics or systemic steroids within 14 days prior to study entry. A history of three or more courses of systemic antibiotics within the 3 month period immediately prior to screening will also be considered exclusionary
Use of topical antibiotics, topical antibacterials, topical antifungals or topical steroids within 14 days prior to study entry on any skin lesion (as deemed significant by the Investigator by virtue of the lesion's nature and/or position to impact on the effectiveness of the study drug)
Participation in any other clinical study or use of any investigational drugs or investigational device within 30 days prior to enrollment
Presence of secondarily infected traumatic lesions (e.g. surgical wounds, animal/insect bites, burns, lacerations and abrasions).
Another family member in same household currently enrolled in this study or another family member in the same household with active impetigo
Facility Information:
Facility Name
SRCR, Inc
City
Bell Gardens
State/Province
California
ZIP/Postal Code
90201
Country
United States
Facility Name
Skin Care research Inc
City
Boca Raton
State/Province
Florida
ZIP/Postal Code
33486
Country
United States
Facility Name
Eastern Research, Inc
City
Hialeah
State/Province
Florida
ZIP/Postal Code
33013
Country
United States
Facility Name
Cyn3rgy Research
City
Gresham
State/Province
Oregon
ZIP/Postal Code
97030
Country
United States
Facility Name
Cheraw Pediatrics, P.A.
City
Cheraw
State/Province
South Carolina
ZIP/Postal Code
29520
Country
United States
Facility Name
Integrity Clinical Research, Inc
City
Milan
State/Province
Tennessee
ZIP/Postal Code
38358
Country
United States
Facility Name
Sealy Urgent Care Center
City
Sealy
State/Province
Texas
ZIP/Postal Code
77474
Country
United States
Facility Name
Langeberg Clinical Trials
City
Kraaifontein
State/Province
Cape Town
ZIP/Postal Code
7570
Country
South Africa
Facility Name
Newtown Clinical Research
City
Johannesburg
State/Province
Gauteng
ZIP/Postal Code
2113
Country
South Africa
Facility Name
Phelang Research Center
City
Pretoria
State/Province
Gauteng
ZIP/Postal Code
0122
Country
South Africa
Facility Name
Setshaba Research Center
City
Soshanguve
State/Province
Gauteng
ZIP/Postal Code
0152
Country
South Africa
Facility Name
Welkom Clinical Trial Center
City
Welkom
State/Province
Gauteng
ZIP/Postal Code
9460
Country
South Africa
Facility Name
Synopsis Research
City
Rondebosch
State/Province
Western Cape
ZIP/Postal Code
7700
Country
South Africa
12. IPD Sharing Statement
Learn more about this trial
Vehicle Controlled Efficacy and Safety Study of Two Dose Regimens of CD07223 1.5% Topical Gel in Impetigo
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