ImpetigoPhase 2NCT01367314
Safety and Efficacy of Topical NVC-422 Gel in Impetigo
A Phase 2 study testing NVC-422 in people with Impetigo, run by NovaBay Pharmaceuticals, Inc. at 2 sites in Dominican Republic.
Trial summary
This is a randomized, double-blind study comparing 0.1% NVC-422, 0.5% NVC-422 and 1.5% NVC-422 topical gel in children with impetigo. Read more about this study
- Who is it for?
- Ages 2 to 12 years
- Conditions the study is for
- Impetigo
- What is being tested?
- NVC-422
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 129 participants
- Where
- 2 sitesDominican Republic
- Study dates
- Aug 2009to Dec 2010
- Phase
- Phase 2
- 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 to 12 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Subjects must be 2 - 12 years of age
- Parents or Legal Guardians must sign a written informed consent document
- Positive Gram stain of target lesion showing Gram-positive cocci;
- Clinical diagnosis of primary non-bullous impetigo as per the protocol
- Skin Infection Rating Scale total score of at least 4, with at least three of the five primary signs and symptoms present at baseline including a score of 1 or greater for exudate/pus;
- Screening within one day of enrollment into the study.
Who cannot join
- Presence of other skin diseases at or near the investigational target area to be treated;
- Disease is so widespread or severe that, in the opinion of the investigator, oral antibiotic treatment is needed
- Active impetigo lesions greater than 5 cm2
- Signs and symptoms of a current infection requiring antibiotic treatment
- Use of systemic or topical antibiotics or steroids within 72 hours prior to study entry
- Females of childbearing potential
Trial locations and contacts
2 sites in 1 country.
Dominican Republic2 sites
Hospital Infantil Dr. Robert Reid Cabral
Santo Domingo
Instituto Dermatológico
Santo Domingo
About this study
Official title: A Phase IIa, Double Blind, Randomized, Sequential Group Study to Evaluate the Safety and Efficacy of Topical NVC-422 Dermal Gel in Impetigo
This is a randomized, double-blind study comparing 0.1% NVC-422, 0.5% NVC-422 and 1.5% NVC-422 topical gel in children with impetigo.
Read the detailed description
This study is a randomized, sequential group, double-blind study. The first 60 subjects enrolled will be randomized to either 0.1% NVC-422 or 0.5% NVC-422. Randomization is 1:2 where 20 subjects will receive 0.1% NVC-422 and 40 subjects will receive 0.5% NVC-422. If there are no safety issues regarding the first 2 doses tested, the next 60 subjects will be randomized to either 0.1% or 1.5% NVC-422 with 20 subjects receiving 0.1% and 40 subjects receiving 1.5% NVC-422.
The lesion most representative of the subject's infection will be identified as the target lesion. This target lesion will be photographed, graded clinically, and its location recorded. At Visit 1, Screening and/or Baseline, a Gram stain will be performed to assess presence of Gram-positive cocci. If Gram-positive cocci are present, a swab for culture and sensitivity will be obtained. Treatment will began immediately after randomization.
Treatment will be 3 times per day (TID) for 7 consecutive days, following a morning, afternoon, and evening schedule.
After the start of treatment (Day 1), subjects will be assessed for safety on Day 4 (± 1). Clinical and bacteriological assessments of the target lesion will also occur on Day 8 (+1) and Follow-up on Day 15 (± 2).
- Conditions
- Impetigo
- Being tested
- NVC-422
- Medical subject headings
- Impetigo
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
NVC-422Drug
Also called Sodium salt of 2-(dichloroamino)-2-methylpropane-1-sulfonate monohydrate
Dermal Gel applied 3 times per day for 7 days
| Study group | Role | What they receive |
|---|---|---|
| NVC-422 Dermal Gel, 1.5% | Experimental | Not described Receives: Drug: NVC-422 |
| NVC-422 Dermal Gel, 0.5% | Experimental | Not described Receives: Drug: NVC-422 |
| NVC-422 Dermal Gel, 0.1% | Experimental | Not described Receives: Drug: NVC-422 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Clinical Response
Sufficient resolution of signs and symptoms of infection of the target lesion such that no additional antimicrobial therapy is required to treat the impetigo as evidenced by the SIRS score of 0 each for exudate/pus, crusting and pain and 0 or 1 each for erythema/inflammation and itching for a clinical success or a SIRS score of 0 for exudate/pus but does not meet all the criteria for clinical success for a clinical improvement.
Measured: End of Treatment (Day 8) and Follow-up (Day 15)
Secondary outcomes (1)
Bacteriological Response
The causative pathogen isolated from the target lesion at Baseline (Staphylococcus aureus and/or Streptococcus pyogenes) are eliminated on culture, or response is such that no material was available for culture and therefore is evidence of pathogen eradication.
Measured: End of Treatment (Day 8) and Follow-up (Day 15)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Jun 2011 (estimated)
- Study startAug 2009
- Primary completionMay 2010
- Study completionDec 2010
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
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 129 participants (actual)
Sponsor and investigators
- Lead sponsor
- NovaBay Pharmaceuticals, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Novum Pharmaceutical Research Services, International Dermatology Research, Inc.
- Investigators
- Kenneth D. Krantz, MD, PhD, Study director, NovaBay Pharmaceuticals, Inc.Daisy M. Blanco, MD, Principal investigator, Instituto DermatológicoJesús Feris-Iglesias, MD, Principal investigator, Hospital Infantil Dr. Robert Reid Cabral
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01367314
- Sponsor's protocol ID
- CL0901
- Status last verified
- Jun 2011
- First submitted
- 3 Jun 2011
- Last updated
- 7 Jun 2011
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 7 Jun 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase IIa, Double Blind, Randomized, Sequential Group Study to Evaluate the Safety and Efficacy of Topical NVC-422 Dermal Gel in Impetigo
- ClinicalTrials.gov ID
- NCT01367314
- Acronym / sponsor ID
- CL0901
- Conditions
- Impetigo
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 129 participants (actual)
- Lead sponsor
- NovaBay Pharmaceuticals, Inc.Industry (pharma, biotech, devices)
- Collaborators
- Novum Pharmaceutical Research Services, International Dermatology Research, Inc.
- Study start
- Aug 2009
- Primary completion
- May 2010 (actual)
- Study completion
- Dec 2010 (actual)
- First posted
- 7 Jun 2011 (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 is a randomized, double-blind study comparing 0.1% NVC-422, 0.5% NVC-422 and 1.5% NVC-422 topical gel in children with impetigo.
Detailed description
This study is a randomized, sequential group, double-blind study. The first 60 subjects enrolled will be randomized to either 0.1% NVC-422 or 0.5% NVC-422. Randomization is 1:2 where 20 subjects will receive 0.1% NVC-422 and 40 subjects will receive 0.5% NVC-422. If there are no safety issues regarding the first 2 doses tested, the next 60 subjects will be randomized to either 0.1% or 1.5% NVC-422 with 20 subjects receiving 0.1% and 40 subjects receiving 1.5% NVC-422.
The lesion most representative of the subject's infection will be identified as the target lesion. This target lesion will be photographed, graded clinically, and its location recorded. At Visit 1, Screening and/or Baseline, a Gram stain will be performed to assess presence of Gram-positive cocci. If Gram-positive cocci are present, a swab for culture and sensitivity will be obtained. Treatment will began immediately after randomization.
Treatment will be 3 times per day (TID) for 7 consecutive days, following a morning, afternoon, and evening schedule.
After the start of treatment (Day 1), subjects will be assessed for safety on Day 4 (± 1). Clinical and bacteriological assessments of the target lesion will also occur on Day 8 (+1) and Follow-up on Day 15 (± 2).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| NVC-422 Dermal Gel, 1.5% | Experimental | Drug: NVC-422 |
| NVC-422 Dermal Gel, 0.5% | Experimental | Drug: NVC-422 |
| NVC-422 Dermal Gel, 0.1% | Experimental | Drug: NVC-422 |
Who may qualify
- Ages
- 2 to 12 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (6 listed)
- Subjects must be 2 - 12 years of age
- Parents or Legal Guardians must sign a written informed consent document
- Positive Gram stain of target lesion showing Gram-positive cocci;
- Clinical diagnosis of primary non-bullous impetigo as per the protocol
- Skin Infection Rating Scale total score of at least 4, with at least three of the five primary signs and symptoms present at baseline including a score of 1 or greater for exudate/pus;
Key exclusion criteria (6 listed)
- Presence of other skin diseases at or near the investigational target area to be treated;
- Disease is so widespread or severe that, in the opinion of the investigator, oral antibiotic treatment is needed
- Active impetigo lesions greater than 5 cm2
- Signs and symptoms of a current infection requiring antibiotic treatment
- Use of systemic or topical antibiotics or steroids within 72 hours prior to study entry
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 |
|---|---|---|
| NVC-422Also: Sodium salt of 2-(dichloroamino)-2-methylpropane-1-sulfonate monohydrateDermal Gel applied 3 times per day for 7 days | Drug | NVC-422 Dermal Gel, 0.1%, NVC-422 Dermal Gel, 0.5%, NVC-422 Dermal Gel, 1.5% |
Primary outcome
Clinical Response
Time frame: End of Treatment (Day 8) and Follow-up (Day 15)
Sufficient resolution of signs and symptoms of infection of the target lesion such that no additional antimicrobial therapy is required to treat the impetigo as evidenced by the SIRS score of 0 each for exudate/pus, crusting and pain and 0 or 1 each for erythema/inflammation and itching for a clinical success or a SIRS score of 0 for exudate/pus but does not meet all the criteria for clinical success for a clinical improvement.
1 secondary outcome
Bacteriological Response
Time frame: End of Treatment (Day 8) and Follow-up (Day 15)
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 7 Jun 2011.
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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.
Kenneth D. Krantz, MD, PhD study director
NovaBay Pharmaceuticals, Inc.
Daisy M. Blanco, MD principal investigator
Instituto Dermatológico
Jesús Feris-Iglesias, MD principal investigator
Hospital Infantil Dr. Robert Reid Cabral
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing NVC-422 in people with Impetigo, run by NovaBay Pharmaceuticals, Inc. at 2 sites in Dominican Republic.
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 6 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 7 Jun 2011. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Dominican Republic. 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. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this 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.
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 Response (time frame: End of Treatment (Day 8) and Follow-up (Day 15)). 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 7 Jun 2011.