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Trial record 2 of 2 for:    cd07223

Vehicle Controlled Efficacy and Safety Study of Two Dose Regimens of CD07223 1.5% Topical Gel in Impetigo

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ClinicalTrials.gov Identifier: NCT01670032
Recruitment Status : Completed
First Posted : August 21, 2012
Last Update Posted : August 12, 2014
Sponsor:
Information provided by (Responsible Party):
NovaBay Pharmaceuticals, Inc.

Tracking Information
First Submitted Date  ICMJE August 17, 2012
First Posted Date  ICMJE August 21, 2012
Last Update Posted Date August 12, 2014
Study Start Date  ICMJE August 2012
Actual Primary Completion Date August 2013   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: August 17, 2012)
Clinical Success at Follow up (Day 15) in the intent-to-treat (ITTC) population [ Time Frame: 2 weeks ]
Clinical Success is defined by the SIRS score of the Target Lesion
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE Not Provided
Original Secondary Outcome Measures  ICMJE Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Vehicle Controlled Efficacy and Safety Study of Two Dose Regimens of CD07223 1.5% Topical Gel in Impetigo
Official Title  ICMJE 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
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.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 2
Phase 3
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Condition  ICMJE Impetigo
Intervention  ICMJE
  • Drug: Experimental: CD07223 1.5 % Topical Gel BID
    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
  • Drug: Experimental: CD07223 1.5% Topical Gel TID
    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
  • Drug: Placebo Comparator: CD07223 vehicle gel BID
    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
  • Drug: Placebo Comparator: CD07223 vehicle gel TID
    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
Study Arms  ICMJE
  • Experimental: CD07223 1.5 % Topical Gel BID
    Drug: 1.5% CD07223 Topical Gel applied BID for 7 days
    Intervention: Drug: Experimental: CD07223 1.5 % Topical Gel BID
  • Experimental: CD07223 1.5% Topical Gel TID
    Drug: 1.5% CD07223 Topical Gel applied TID for 7 days
    Intervention: Drug: Experimental: CD07223 1.5% Topical Gel TID
  • Placebo Comparator: CD07223 vehicle gel BID
    Drug: CD07223 Vehicle Topical Gel applied BID for 7 days
    Intervention: Drug: Placebo Comparator: CD07223 vehicle gel BID
  • Placebo Comparator: CD07223 vehicle gel TID
    Drug: CD07223 Vehicle Topical Gel applied TID for 7 days
    Intervention: Drug: Placebo Comparator: CD07223 vehicle gel TID
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: September 3, 2013)
328
Original Estimated Enrollment  ICMJE
 (submitted: August 17, 2012)
304
Actual Study Completion Date  ICMJE August 2013
Actual Primary Completion Date August 2013   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 2 Years and older   (Child, Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE South Africa,   United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT01670032
Other Study ID Numbers  ICMJE RD.06. SPR. 18216
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party NovaBay Pharmaceuticals, Inc.
Study Sponsor  ICMJE NovaBay Pharmaceuticals, Inc.
Collaborators  ICMJE Not Provided
Investigators  ICMJE Not Provided
PRS Account NovaBay Pharmaceuticals, Inc.
Verification Date August 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP