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

Impetigo Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01670032
• Other study ID #: RD.06. SPR. 18216
• Status: Completed
• Phase: Phase 2/Phase 3
• First received: August 17, 2012
• Last updated: August 8, 2014
• Start date: August 2012
• Est. completion date: August 2013

Study information

• Verified date: August 2014
• Source: NovaBay Pharmaceuticals, Inc.
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug AdministrationSouth Africa: Medicines Control CouncilMexico: COFREPIS
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 328
• Est. completion date: August 2013
• Est. primary completion date: August 2013
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 2 Years and older

Eligibility

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 Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Impetigo

Intervention

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
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
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
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

Locations

Country	Name	City	State
South Africa	Newtown Clinical Research	Johannesburg	Gauteng
South Africa	Langeberg Clinical Trials	Kraaifontein	Cape Town
South Africa	Phelang Research Center	Pretoria	Gauteng
South Africa	Synopsis Research	Rondebosch	Western Cape
South Africa	Setshaba Research Center	Soshanguve	Gauteng
South Africa	Welkom Clinical Trial Center	Welkom	Gauteng
United States	SRCR, Inc	Bell Gardens	California
United States	Skin Care research Inc	Boca Raton	Florida
United States	Cheraw Pediatrics, P.A.	Cheraw	South Carolina
United States	Cyn3rgy Research	Gresham	Oregon
United States	Eastern Research, Inc	Hialeah	Florida
United States	Integrity Clinical Research, Inc	Milan	Tennessee
United States	Sealy Urgent Care Center	Sealy	Texas

Sponsors (1)

Lead Sponsor	Collaborator
NovaBay Pharmaceuticals, Inc.

Countries where clinical trial is conducted

United States,  South Africa, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No