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| Name | Class |
|---|---|
| GlaxoSmithKline | INDUSTRY |
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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.
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.
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Retapamulin 1% | Drug | 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. |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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. | Day 1 and Day 7 |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | Day 1 and Day 7 |
| Investigator Assessment of Clinical Cure |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Leon H. Kircik, M.D. | DermResearch, PLLC | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| DermResearch, PLLC | Louisville | Kentucky | 40217 | United States |
Seventy subjects were enrolled into the study. Of these 29 had a positive culture for s. aureus (MRSA and MSSA) or S. pyogenes
Subjects with suspected secondarily infected atopic dermatitis were recruited from the investigator's medical practice. Recruitment occurred from July 2010 through November 2011
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| ID | Title | Description |
|---|---|---|
| FG000 | All Participants | All consented subjects with an apparent secondary infection were cultured.The treatment of Retapamulin 1% was started , with a thin layer applied twice daily and covered with gauze (if desired) for 7 days. The subject treatment site was cultured after 7 days of treatment. |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
Baseline characteristics are provided only for those subjects with a positive culture
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| ID | Title | Description |
|---|---|---|
| BG000 | All Participants | All consented subjects with a suspected secondary infection of atopic dermatitis were cultured.The treatment of Retapamulin 1% was started , with a thin layer applied twice daily and covered with gauze (if desired) for 7 days. The subject treatment site was cultured after 7 days of treatment. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | 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. | Posted | Number | participants | Day 1 and Day 7 |
|
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | All Participants | All consented subjects with a suspected secondary infection of atopic dermatitis were cultured.The treatment of Retapamulin 1% was started , with a thin layer applied twice daily and covered with gauze (if desired) for 7 days. The subject treatment site was cultured after 7 days of treatment. |
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small number of subjects/short duration of study treatment
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Leon H. Kircik, M.D. | DermResearch, PLLC | 502-451-9000 | wedoderm@yahoo.com |
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| ID | Term |
|---|---|
| D003876 | Dermatitis, Atopic |
| D060085 | Coinfection |
| ID | Term |
|---|---|
| D012873 | Skin Diseases, Genetic |
| D030342 | Genetic Diseases, Inborn |
| D009358 | Congenital, Hereditary, and Neonatal Diseases and Abnormalities |
| D003872 | Dermatitis |
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| ID | Term |
|---|---|
| C508887 | retapamulin |
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The investigator assessed clinical cure at Day 7 as either total or improved cure, failure confirmed or failure by default |
| 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. | Day 7 |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
| Units | Counts |
|---|---|
| Participants |
|
|
| Secondary | 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. | Posted | Median | Inter-Quartile Range | units on a scale | Day 1 and Day 7 |
|
|
|
| Secondary | 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 | Posted | Number | participants | Day 7 |
|
|
|
| Secondary | 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. | Posted | Median | Inter-Quartile Range | units on a scale | Day 7 |
|
|
|
| 0 |
| 70 |
| 0 |
| 70 |
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| D012871 | Skin Diseases |
| D017437 | Skin and Connective Tissue Diseases |
| D017443 | Skin Diseases, Eczematous |
| D006969 | Hypersensitivity, Immediate |
| D006967 | Hypersensitivity |
| D007154 | Immune System Diseases |
| D007239 | Infections |
| Title | Measurements |
|---|---|
|
| inflammation |
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| swelling |
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| infection |
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| peeling |
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| contact dermatitis |
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| iritation |
|
| itchiness |
|
| burning |
|
| tenderness |
|
| pain |
|