Atopic DermatitisPhase 4NCT01064947
Safety and Efficacy Study of Altabax Ointment in the Treatment of Secondarily Infected Atopic Dermatitis
A Phase 4 study testing Retapamulin 1% in people with Atopic Dermatitis and Secondary Infection, run by Derm Research, PLLC at 1 site in United States.
Trial summary
Skin infections may complicate the treatment of atopic dermatitis.The use of topical ointments has become very important to avoid the use of oral antibiotics. There is little supporting literature regarding the use of topical antibiotics in secondarily infected atopic dermatitis. Read more about this study
- Who is it for?
- Ages 2 years and older
- Conditions the study is for
- Atopic Dermatitis, Secondary Infection
- What is being tested?
- Retapamulin 1%
- How many people
- 29 participants
- Where
- 1 siteUnited States
- Study dates
- Feb 2010to Jan 2012
- Phase
- Phase 4
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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
- Female subjects of childbearing potential must have a negative urine pregnancy test at Baseline and practice a reliable method of contraception.
- Secondary infection of atopic dermatitis with S.aureus or S.pyogenes as the probable causative agent.
- An infected area less than or equal to 100 centimeters squared for subjects 18 years of age or older, or, 2% body surface area for subjects under 18 years of age.
- Skin Infection Rating Scale score greater than or equal to 8.
- Able to understand and comply with the requirements of the study and sign Informed Consent/Health Insurance Portability and Accountability Authorization Forms. Subjects under the legal age of consent must also have the written informed consent of parent or legal guardian.
Who cannot join
- Female subjects who are pregnant, trying to get pregnant, breast feeding or who are of childbearing potential and not practicing reliable birth control.
- Allergic to any component of the test medication.
- Clinical diagnosis of impetigo, folliculitis or minor soft tissue infection.
- Use of topical antibacterial medication to the study treatment area within 1 day of Visit 1.
- Signs of systemic infection or evidence of abcess or cellulitis at the site to be treated.
- Medical condition that,in the opinion of the investigator, contraindicates the subject's participation in the clinical study.
Show all 9Show fewer
- Recent alcohol or drug abuse is evident.
- History of poor cooperation, non-compliance with medical treatment or unreliability.
- Participation in an investigational drug study within 30 days of Baseline Visit.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Use of Altabax Ointment (Retapamulin 1%) BID for 7 Days in Treatment of Secondary Infection With Staphylococcus Aureus (MRSA and MSSA) and Streptococcus Pyogenes in Atopic Dermatitis Patients - Open Label Pilot Study
Skin infections may complicate the treatment of atopic dermatitis.The use of topical ointments has become very important to avoid the use of oral antibiotics. There is little supporting literature regarding the use of topical antibiotics in secondarily infected atopic dermatitis.
This study will investigate the safety and effectiveness of Altabax ointment use in treating secondarily infected atopic dermatitis caused by Staphylococcus aureus and Streptococcus pyogenes.
Read the detailed description
Atopic dermatitis patients are commonly secondarily infected with Staphylococcus aureus and/or Streptococcus pyogenes, more recently with Methicillin-resistant Staphylococcus aureus (MRSA), due to impaired barrier function. As cutaneous infections such as MRSA and others may complicate the treatment of atopic dermatitis, the use of topical antibiotics have become very important to avoid oral antibiotics and their side effects, especially in the pediatric population.
The current study will investigate the safety and efficacy of Altabax ointment use for treatment of secondarily infected lesions caused by Staphylococcus aureus and Streptococcus pyogenes in both the pediatric and adult populations.
- Conditions
- Atopic Dermatitis, Secondary Infection
- Being tested
- Retapamulin 1%
- Medical subject headings
- Dermatitis, Atopic, Coinfection
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Retapamulin 1%Drug
Also called Altabax
Apply a thin layer of Retapamulin 1% to the affected area twice daily. The treated area may be covered with a sterile bandage or gauze dressing if desired.
What is being measured
The primary outcome is the main question the study is designed to answer.
Bacteriological Culture
All participants were cultured for S.aureus (MRSA), S.aureus (MSSA) and S. pyogenes at Baseline. If positive at Baseline then they were cultured again at Day 7.
Measured: Day 1 and Day 7
Secondary outcomes (3)
Skin Infection Rating Scale (SIRS)
The Primary Investigator rated the each of the following characteristics: exudate/pus, crusting, erythema/inflammation, tissue warmth, tissue edema, itching and pain on a scale of 0-6 (absent-severe) to create an overall SIRS score ranging from 0-42.
Measured: Day 1 and Day 7
Investigator Assessment of Clinical Cure
The investigator assessed clinical cure at Day 7 as either total or improved cure, failure confirmed or failure by default
Measured: Day 7
Local Tolerability
The investigator assessed the following characteristics on a grading scale of 0-3 (none, mild moderate or severe): erythema, inflammation, infection, crusting, necrosis, peeling, swelling and contact dermatitis.
The subject assessed the following characteristics on a scale of 0-3 (none, mild, moderate or severe): irritation, itchiness burning, tenderness and pain.
Measured: Day 7
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Feb 2010 (estimated)
- Study startFeb 2010
- Primary completionJan 2012
- Study completionJan 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Atopic DermatitisStudies 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 4
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 29 participants (actual)
Sponsor and investigators
- Lead sponsor
- Derm Research, PLLC
- Sponsor type
- University, hospital or other
- Collaborators
- GlaxoSmithKline
- Responsible party
- Principal investigator, Leon Kircik, M.D., Derm Research, PLLC
- Investigators
- Leon H. Kircik, M.D., Principal investigator, DermResearch, PLLC
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01064947
- Sponsor's protocol ID
- ALT113706
- Status last verified
- Apr 2013
- First submitted
- 8 Feb 2010
- Last updated
- 22 Sep 2016
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 22 Sep 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Use of Altabax Ointment (Retapamulin 1%) BID for 7 Days in Treatment of Secondary Infection With Staphylococcus Aureus (MRSA and MSSA) and Streptococcus Pyogenes in Atopic Dermatitis Patients - Open Label Pilot Study
- ClinicalTrials.gov ID
- NCT01064947
- Acronym / sponsor ID
- ALT113706
- Conditions
- Atopic Dermatitis, Secondary Infection
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 29 participants (actual)
- Lead sponsor
- Derm Research, PLLCUniversity, hospital or other
- Collaborators
- GlaxoSmithKline
- Study start
- Feb 2010
- Primary completion
- Jan 2012 (actual)
- Study completion
- Jan 2012 (actual)
- First posted
- 9 Feb 2010 (estimated)
- Results
- Posted 4 Jul 2013
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Skin infections may complicate the treatment of atopic dermatitis.The use of topical ointments has become very important to avoid the use of oral antibiotics. There is little supporting literature regarding the use of topical antibiotics in secondarily infected atopic dermatitis.
This study will investigate the safety and effectiveness of Altabax ointment use in treating secondarily infected atopic dermatitis caused by Staphylococcus aureus and Streptococcus pyogenes.
Detailed description
Atopic dermatitis patients are commonly secondarily infected with Staphylococcus aureus and/or Streptococcus pyogenes, more recently with Methicillin-resistant Staphylococcus aureus (MRSA), due to impaired barrier function. As cutaneous infections such as MRSA and others may complicate the treatment of atopic dermatitis, the use of topical antibiotics have become very important to avoid oral antibiotics and their side effects, especially in the pediatric population.
The current study will investigate the safety and efficacy of Altabax ointment use for treatment of secondarily infected lesions caused by Staphylococcus aureus and Streptococcus pyogenes in both the pediatric and adult populations.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
Who may qualify
- Ages
- 2 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (5 listed)
- Female subjects of childbearing potential must have a negative urine pregnancy test at Baseline and practice a reliable method of contraception.
- Secondary infection of atopic dermatitis with S.aureus or S.pyogenes as the probable causative agent.
- An infected area less than or equal to 100 centimeters squared for subjects 18 years of age or older, or, 2% body surface area for subjects under 18 years of age.
- Skin Infection Rating Scale score greater than or equal to 8.
- Able to understand and comply with the requirements of the study and sign Informed Consent/Health Insurance Portability and Accountability Authorization Forms. Subjects under the legal age of consent must also have the written informed consent of parent or legal guardian.
Key exclusion criteria (9 listed)
- Female subjects who are pregnant, trying to get pregnant, breast feeding or who are of childbearing potential and not practicing reliable birth control.
- Allergic to any component of the test medication.
- Clinical diagnosis of impetigo, folliculitis or minor soft tissue infection.
- Use of topical antibacterial medication to the study treatment area within 1 day of Visit 1.
- Signs of systemic infection or evidence of abcess or cellulitis at the site to be treated.
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 |
|---|---|---|
| Retapamulin 1%Also: AltabaxApply a thin layer of Retapamulin 1% to the affected area twice daily. The treated area may be covered with a sterile bandage or gauze dressing if desired. | Drug | – |
Primary outcome
Bacteriological Culture
Time frame: Day 1 and Day 7
All participants were cultured for S.aureus (MRSA), S.aureus (MSSA) and S. pyogenes at Baseline. If positive at Baseline then they were cultured again at Day 7.
3 secondary outcomes
Skin Infection Rating Scale (SIRS)
Time frame: Day 1 and Day 7
Investigator Assessment of Clinical Cure
Time frame: Day 7
Local Tolerability
Time frame: Day 7
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Sep 2016.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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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.
Leon H. Kircik, M.D. principal investigator
DermResearch, PLLC
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Retapamulin 1% in people with Atopic Dermatitis and Secondary Infection, run by Derm Research, PLLC at 1 site in United States.
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 5 inclusion and 9 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 22 Sep 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. 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 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 4 Jul 2013). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Bacteriological Culture (time frame: Day 1 and Day 7). 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 22 Sep 2016.