NCT01670032

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.

Trial Health

90
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
328

participants targeted

Target at P75+ for phase_2

Timeline
Completed

Started Aug 2012

Shorter than P25 for phase_2

Geographic Reach
2 countries

13 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

August 1, 2012

Completed
16 days until next milestone

First Submitted

Initial submission to the registry

August 17, 2012

Completed
4 days until next milestone

First Posted

Study publicly available on registry

August 21, 2012

Completed
12 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2013

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2013

Completed
Last Updated

August 12, 2014

Status Verified

August 1, 2014

Enrollment Period

1 year

First QC Date

August 17, 2012

Last Update Submit

August 8, 2014

Conditions

Impetigo

Outcome Measures

Primary Outcomes (1)

  • 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

Study Arms (4)

CD07223 1.5 % Topical Gel BID

EXPERIMENTAL

Drug: 1.5% CD07223 Topical Gel applied BID for 7 days

Drug: Experimental: CD07223 1.5 % Topical Gel BID

CD07223 1.5% Topical Gel TID

EXPERIMENTAL

Drug: 1.5% CD07223 Topical Gel applied TID for 7 days

Drug: Experimental: CD07223 1.5% Topical Gel TID

CD07223 vehicle gel BID

PLACEBO COMPARATOR

Drug: CD07223 Vehicle Topical Gel applied BID for 7 days

Drug: Placebo Comparator: CD07223 vehicle gel BID

CD07223 vehicle gel TID

PLACEBO COMPARATOR

Drug: CD07223 Vehicle Topical Gel applied TID for 7 days

Drug: Placebo Comparator: CD07223 vehicle gel TID

Interventions

Experimental: CD07223 1.5 % Topical Gel BIDDRUG

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

CD07223 1.5 % Topical Gel BID
Experimental: CD07223 1.5% Topical Gel TIDDRUG

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

CD07223 1.5% Topical Gel TID
Placebo Comparator: CD07223 vehicle gel BIDDRUG

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

CD07223 vehicle gel BID
Placebo Comparator: CD07223 vehicle gel TIDDRUG

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

CD07223 vehicle gel TID

Eligibility Criteria

Age2 Years+
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (13)

SRCR, Inc

Bell Gardens, California, 90201, United States

Location

Skin Care research Inc

Boca Raton, Florida, 33486, United States

Location

Eastern Research, Inc

Hialeah, Florida, 33013, United States

Location

Cyn3rgy Research

Gresham, Oregon, 97030, United States

Location

Cheraw Pediatrics, P.A.

Cheraw, South Carolina, 29520, United States

Location

Integrity Clinical Research, Inc

Milan, Tennessee, 38358, United States

Location

Sealy Urgent Care Center

Sealy, Texas, 77474, United States

Location

Langeberg Clinical Trials

Kraaifontein, Cape Town, 7570, South Africa

Location

Newtown Clinical Research

Johannesburg, Gauteng, 2113, South Africa

Location

Phelang Research Center

Pretoria, Gauteng, 0122, South Africa

Location

Setshaba Research Center

Soshanguve, Gauteng, 0152, South Africa

Location

Welkom Clinical Trial Center

Welkom, Gauteng, 9460, South Africa

Location

Synopsis Research

Rondebosch, Western Cape, 7700, South Africa

Location

MeSH Terms

Conditions

Impetigo

Condition Hierarchy (Ancestors)

Staphylococcal Skin InfectionsStaphylococcal InfectionsGram-Positive Bacterial InfectionsBacterial InfectionsBacterial Infections and MycosesInfectionsStreptococcal InfectionsSkin Diseases, BacterialSkin Diseases, InfectiousSkin DiseasesSkin and Connective Tissue Diseases

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

August 17, 2012

First Posted

August 21, 2012

Study Start

August 1, 2012

Primary Completion

August 1, 2013

Study Completion

August 1, 2013

Last Updated

August 12, 2014

Record last verified: 2014-08

Locations

ZA(6)US(7)