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

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

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.

Study Overview

• Status: Completed
• Conditions: Impetigo
• Intervention / Treatment: Drug: Experimental: CD07223 1.5 % Topical Gel BID; Drug: Experimental: CD07223 1.5% Topical Gel TID; Drug: Placebo Comparator: CD07223 vehicle gel BID; Drug: Placebo Comparator: CD07223 vehicle gel TID

• Study Type: Interventional
• Enrollment (Actual): 328
• Phase: Phase 2; Phase 3

Contacts and Locations

Study Locations

• South Africa
  • Cape Town
    • Kraaifontein, Cape Town, South Africa, 7570
      • Langeberg Clinical Trials
  • Gauteng
    • Johannesburg, Gauteng, South Africa, 2113
      • Newtown Clinical Research
    • Pretoria, Gauteng, South Africa, 0122
      • Phelang Research Center
    • Soshanguve, Gauteng, South Africa, 0152
      • Setshaba Research Center
    • Welkom, Gauteng, South Africa, 9460
      • Welkom Clinical Trial Center
  • Western Cape
    • Rondebosch, Western Cape, South Africa, 7700
      • Synopsis Research
• United States
  • California
    • Bell Gardens, California, United States, 90201
      • SRCR, Inc
  • Florida
    • Boca Raton, Florida, United States, 33486
      • Skin Care Research Inc
    • Hialeah, Florida, United States, 33013
      • Eastern Research, Inc
  • Oregon
    • Gresham, Oregon, United States, 97030
      • Cyn3rgy Research
  • South Carolina
    • Cheraw, South Carolina, United States, 29520
      • Cheraw Pediatrics, P.A.
  • Tennessee
    • Milan, Tennessee, United States, 38358
      • Integrity Clinical Research, Inc
  • Texas
    • Sealy, Texas, United States, 77474
      • Sealy Urgent Care Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 2 years and older (ADULT, OLDER_ADULT, CHILD)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: QUADRUPLE

Number of Arms

4

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
EXPERIMENTAL: CD07223 1.5 % Topical Gel BID; Drug: 1.5% CD07223 Topical Gel applied BID for 7 days	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
EXPERIMENTAL: CD07223 1.5% Topical Gel TID; Drug: 1.5% CD07223 Topical Gel applied TID for 7 days	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
PLACEBO_COMPARATOR: CD07223 vehicle gel BID; Drug: CD07223 Vehicle Topical Gel applied BID for 7 days	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
PLACEBO_COMPARATOR: CD07223 vehicle gel TID; Drug: CD07223 Vehicle Topical Gel applied TID for 7 days	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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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	2 weeks

Collaborators and Investigators

• Sponsor: NovaBay Pharmaceuticals, Inc.

Study record dates

Study Major Dates

• Study Start: August 1, 2012
• Primary Completion (ACTUAL): August 1, 2013
• Study Completion (ACTUAL): August 1, 2013

Study Registration Dates

• First Submitted: August 17, 2012
• First Submitted That Met QC Criteria: August 17, 2012
• First Posted (ESTIMATE): August 21, 2012

Study Record Updates

• Last Update Posted (ESTIMATE): August 12, 2014
• Last Update Submitted That Met QC Criteria: August 8, 2014
• Last Verified: August 1, 2014

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Skin Diseases; Infections; Bacterial Infections; Bacterial Infections and Mycoses; Streptococcal Infections; Gram-Positive Bacterial Infections; Skin Diseases, Infectious; Staphylococcal Infections; Skin Diseases, Bacterial; Staphylococcal Skin Infections; Impetigo
• Other Study ID Numbers: RD.06. SPR. 18216