Back to resultsSafety and Efficacy Study of Altabax Ointment in the Treatment of Secondarily Infected Atopic Dermatitis
Primary Purpose
Atopic Dermatitis, Secondary Infection
Status
Completed
Phase
Phase 4
Locations
United States
Study Type
Interventional
Intervention
Retapamulin 1%
Sponsored by
About this trial
This is an interventional treatment trial for Atopic Dermatitis
Eligibility Criteria
Inclusion Criteria:
- 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.
Exclusion Criteria:
- 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.
- 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.
Sites / Locations
- DermResearch, PLLC
Outcomes
Primary Outcome Measures
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.
Secondary Outcome Measures
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.
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
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.
Full Information
NCT ID
NCT01064947
First Posted
February 8, 2010
Last Updated
August 15, 2016
Sponsor
Derm Research, PLLC
Collaborators
GlaxoSmithKline
1. Study Identification
Unique Protocol Identification Number
NCT01064947
Brief Title
Safety and Efficacy Study of Altabax Ointment in the Treatment of Secondarily Infected Atopic Dermatitis
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
Study Type
Interventional
2. Study Status
Record Verification Date
April 2013
Overall Recruitment Status
Completed
Study Start Date
February 2010 (undefined)
Primary Completion Date
January 2012 (Actual)
Study Completion Date
January 2012 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Derm Research, PLLC
Collaborators
GlaxoSmithKline
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief 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.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Atopic Dermatitis, Secondary Infection
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
29 (Actual)
8. Arms, Groups, and Interventions
Intervention Type
Drug
Intervention Name(s)
Retapamulin 1%
Other Intervention Name(s)
Altabax
Intervention Description
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.
Primary Outcome Measure Information:
Title
Bacteriological Culture
Description
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.
Time Frame
Day 1 and Day 7
Secondary Outcome Measure Information:
Title
Skin Infection Rating Scale (SIRS)
Description
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.
Time Frame
Day 1 and Day 7
Title
Investigator Assessment of Clinical Cure
Description
The investigator assessed clinical cure at Day 7 as either total or improved cure, failure confirmed or failure by default
Time Frame
Day 7
Title
Local Tolerability
Description
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.
Time Frame
Day 7
10. Eligibility
Sex
All
Minimum Age & Unit of Time
2 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
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.
Exclusion Criteria:
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.
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Leon H. Kircik, M.D.
Organizational Affiliation
DermResearch, PLLC
Official's Role
Principal Investigator
Facility Information:
Facility Name
DermResearch, PLLC
City
Louisville
State/Province
Kentucky
ZIP/Postal Code
40217
Country
United States
12. IPD Sharing Statement
Learn more about this trial
Safety and Efficacy Study of Altabax Ointment in the Treatment of Secondarily Infected Atopic Dermatitis
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