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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Galderma
ClinicalTrials.gov Identifier:
NCT01670032
First received: August 17, 2012
Last updated: September 3, 2013
Last verified: September 2013
  Purpose

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.


Condition Intervention Phase
Impetigo
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
Phase 2
Phase 3

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

Resource links provided by NLM:


Further study details as provided by Galderma:

Primary Outcome Measures:
  • Clinical Success at Follow up (Day 15) in the intent-to-treat (ITTC) population [ Time Frame: 2 weeks ] [ Designated as safety issue: No ]
    Clinical Success is defined by the SIRS score of the Target Lesion


Enrollment: 328
Study Start Date: August 2012
Study Completion Date: August 2013
Primary Completion Date: August 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

  Eligibility

Ages Eligible for Study:   2 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01670032

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

No publications provided

Responsible Party: Galderma
ClinicalTrials.gov Identifier: NCT01670032     History of Changes
Other Study ID Numbers: RD.06. SPR. 18216
Study First Received: August 17, 2012
Last Updated: September 3, 2013
Health Authority: United States: Food and Drug Administration
South Africa: Medicines Control Council
Mexico: COFREPIS

Additional relevant MeSH terms:
Impetigo
Staphylococcal Skin Infections
Staphylococcal Infections
Gram-Positive Bacterial Infections
Bacterial Infections
Streptococcal Infections
Skin Diseases, Bacterial
Skin Diseases, Infectious
Infection
Skin Diseases

ClinicalTrials.gov processed this record on July 31, 2014