ImpetigoPhase 2/3NCT01670032
Vehicle Controlled Efficacy and Safety Study of Two Dose Regimens of CD07223 1.5% Topical Gel in Impetigo
A Phase 2/3 study testing Experimental: CD07223 1.5 % Topical Gel BID and Experimental: CD07223 1.5% Topical Gel TID in people with Impetigo, run by NovaBay Pharmaceuticals, Inc. at 13 sites in 2 countries.
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… Read more about this study
- Who is it for?
- Ages 2 years and older
- Conditions the study is for
- Impetigo
- What is being tested?
- Experimental: CD07223 1.5 % Topical Gel BID and Experimental: CD07223 1.5% Topical Gel TID
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 328 participants
- Where
- 13 sitesin 2 countries
- Study dates
- Aug 2012to Aug 2013
- Phase
- Phase 2/3
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 2 years and older
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Show all 11Show fewer
- 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
Trial locations and contacts
13 sites in 2 countries.
13 sites in 2 countries
United States7 sites
SRCR, Inc
Bell Gardens, California, 90201
Skin Care research Inc
Boca Raton, Florida, 33486
Cheraw Pediatrics, P.A.
Cheraw, South Carolina, 29520
Cyn3rgy Research
Gresham, Oregon, 97030
Eastern Research, Inc
Hialeah, Florida, 33013
Integrity Clinical Research, Inc
Milan, Tennessee, 38358
Sealy Urgent Care Center
Sealy, Texas, 77474
South Africa6 sites
Newtown Clinical Research
Johannesburg, Gauteng, 2113
Langeberg Clinical Trials
Kraaifontein, Cape Town, 7570
Phelang Research Center
Pretoria, Gauteng, 0122
Synopsis Research
Rondebosch, Western Cape, 7700
Setshaba Research Center
Soshanguve, Gauteng, 0152
Welkom Clinical Trial Center
Welkom, Gauteng, 9460
About this study
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
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.
- Conditions
- Impetigo
- Being tested
- Experimental: CD07223 1.5 % Topical Gel BID, Experimental: CD07223 1.5% Topical Gel TID, Placebo Comparator: CD07223 vehicle gel BID, Placebo Comparator: CD07223 vehicle gel TID
- Medical subject headings
- Impetigo
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
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
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
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
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
| Study group | Role | What they receive |
|---|---|---|
| CD07223 1.5 % Topical Gel BID | Experimental | Drug: 1.5% CD07223 Topical Gel applied BID for 7 days Receives: 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 Receives: Drug: Experimental: CD07223 1.5% Topical Gel TID |
| CD07223 vehicle gel BID | Placebo comparator | Drug: CD07223 Vehicle Topical Gel applied BID for 7 days Receives: Drug: Placebo Comparator: CD07223 vehicle gel BID |
| CD07223 vehicle gel TID | Placebo comparator | Drug: CD07223 Vehicle Topical Gel applied TID for 7 days Receives: Drug: Placebo Comparator: CD07223 vehicle gel TID |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 2 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Aug 2012 (estimated)
- Study startAug 2012
- Primary completionAug 2013
- Study completionAug 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for ImpetigoStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2/3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 328 participants (actual)
Sponsor and investigators
- Lead sponsor
- NovaBay Pharmaceuticals, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01670032
- Sponsor's protocol ID
- RD.06. SPR. 18216
- Status last verified
- Aug 2014
- First submitted
- 17 Aug 2012
- Last updated
- 12 Aug 2014
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 12 Aug 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT01670032
- Acronym / sponsor ID
- RD.06. SPR. 18216
- Conditions
- Impetigo
- Phase
- Phase 2/3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 328 participants (actual)
- Lead sponsor
- NovaBay Pharmaceuticals, Inc.Industry (pharma, biotech, devices)
- Study start
- Aug 2012
- Primary completion
- Aug 2013 (actual)
- Study completion
- Aug 2013 (actual)
- First posted
- 21 Aug 2012 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| CD07223 1.5 % Topical Gel BID | Experimental | Drug: Experimental: CD07223 1.5 % Topical Gel BIDDrug: 1.5% CD07223 Topical Gel applied BID for 7 days |
| CD07223 1.5% Topical Gel TID | Experimental | Drug: Experimental: CD07223 1.5% Topical Gel TIDDrug: 1.5% CD07223 Topical Gel applied TID for 7 days |
| CD07223 vehicle gel BID | Placebo comparator | Drug: Placebo Comparator: CD07223 vehicle gel BIDDrug: CD07223 Vehicle Topical Gel applied BID for 7 days |
| CD07223 vehicle gel TID | Placebo comparator | Drug: Placebo Comparator: CD07223 vehicle gel TIDDrug: CD07223 Vehicle Topical Gel applied TID for 7 days |
Who may qualify
- Ages
- 2 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (6 listed)
- 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.
Key exclusion criteria (11 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Experimental: CD07223 1.5 % Topical Gel BIDEligible 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 | Drug | CD07223 1.5 % Topical Gel BID |
| Experimental: CD07223 1.5% Topical Gel TIDEligible 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 | Drug | CD07223 1.5% Topical Gel TID |
| Placebo Comparator: CD07223 vehicle gel BIDEligible 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 | Drug | CD07223 vehicle gel BID |
| Placebo Comparator: CD07223 vehicle gel TIDEligible 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 | Drug | CD07223 vehicle gel TID |
Primary outcome
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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Aug 2014.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
13 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2/3 study testing Experimental: CD07223 1.5 % Topical Gel BID and Experimental: CD07223 1.5% Topical Gel TID in people with Impetigo, run by NovaBay Pharmaceuticals, Inc. at 13 sites in 2 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 12 Aug 2014. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 13 sites in United States, South Africa. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this combined phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Clinical Success at Follow up (Day 15) in the intent-to-treat (ITTC) population (time frame: 2 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 Aug 2014.