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NCT Number: NCT01670032

Vehicle Controlled Efficacy and Safety Study of Two Dose Regimens of CD07223 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.

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Key information

Conditions

Impetigo Bacterial Infections Bacterial Infections and Mycoses Gram-Positive Bacterial Infections Infections Skin Diseases Skin Diseases, Bacterial Skin Diseases, Infectious Skin and Connective Tissue Diseases Staphylococcal Infections Staphylococcal Skin Infections Streptococcal Infections

Age range

2 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2 / Phase 3

Primary location

Langeberg Clinical Trials, Kraaifontein, Cape Town, South Africa

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Experimental: CD07223 1.5 % Topical Gel BID

Drug

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

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

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

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 outcomes

  1. 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

Sponsors and collaborators

Lead sponsor

NovaBay Pharmaceuticals, Inc.

Industry

Registry information

Official study 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

Important dates

Study start
2012
Primary completion
2013
Study completion
2013
First posted
Aug 21, 2012
Registry last updated
Aug 12, 2014

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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