Atopic Dermatitis, Secondary Infection
Conditions
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.
Interventions
DRUGRetapamulin 1%
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.
Sponsors
GlaxoSmithKline
Derm Research, PLLC
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
2 Years to No maximum
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Bacteriological Culture | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Skin Infection Rating Scale (SIRS) | Day 1 and Day 7 | 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 | Day 7 | The investigator assessed clinical cure at Day 7 as either total or improved cure, failure confirmed or failure by default |
| Local Tolerability | Day 7 | 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. |
Countries
United States
Participant flow
Recruitment details
Subjects with suspected secondarily infected atopic dermatitis were recruited from the investigator's medical practice. Recruitment occurred from July 2010 through November 2011
Pre-assignment details
Seventy subjects were enrolled into the study. Of these 29 had a positive culture for s. aureus (MRSA and MSSA) or S. pyogenes
Participants by arm
| Arm | Count |
|---|---|
| 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. | 29 |
| Total | 29 |
Withdrawals & dropouts
| Period | Reason | FG000 |
|---|---|---|
| Overall Study | negative culture | 41 |
Baseline characteristics
| Characteristic | All Participants |
|---|---|
| Age, Continuous | 36.6 years |
| Region of Enrollment United States | 29 participants |
| Sex: Female, Male Female | 20 Participants |
| Sex: Female, Male Male | 9 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | — / — |
| other Total, other adverse events | 0 / 70 |
| serious Total, serious adverse events | 0 / 70 |
Outcome results
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.
Time frame: Day 1 and Day 7
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| All Participants at Day 1 | Bacteriological Culture | S. aureus (MRSA) | 13 participants |
| All Participants at Day 1 | Bacteriological Culture | S. aureus (MSSA) | 16 participants |
| All Participants at Day 1 | Bacteriological Culture | S. pyogenes | 0 participants |
| Participants With a Positive Culture at Day 1 | Bacteriological Culture | S. aureus (MRSA) | 3 participants |
| Participants With a Positive Culture at Day 1 | Bacteriological Culture | S. aureus (MSSA) | 5 participants |
| Participants With a Positive Culture at Day 1 | Bacteriological Culture | S. pyogenes | 0 participants |
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
Time frame: Day 7
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| All Participants at Day 1 | Investigator Assessment of Clinical Cure | clinical cure total | 12 participants |
| All Participants at Day 1 | Investigator Assessment of Clinical Cure | clinical cure improved | 15 participants |
| All Participants at Day 1 | Investigator Assessment of Clinical Cure | failure - confirmed and default | 2 participants |
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.
Time frame: Day 7
| Arm | Measure | Group | Value (MEDIAN) |
|---|---|---|---|
| All Participants at Day 1 | Local Tolerability | erythema | 1.00 units on a scale |
| All Participants at Day 1 | Local Tolerability | crusting | 0.00 units on a scale |
| All Participants at Day 1 | Local Tolerability | necrosis | 0.00 units on a scale |
| All Participants at Day 1 | Local Tolerability | inflammation | 0.00 units on a scale |
| All Participants at Day 1 | Local Tolerability | swelling | 0.00 units on a scale |
| All Participants at Day 1 | Local Tolerability | infection | 0.00 units on a scale |
| All Participants at Day 1 | Local Tolerability | peeling | 0.00 units on a scale |
| All Participants at Day 1 | Local Tolerability | contact dermatitis | 0.00 units on a scale |
| All Participants at Day 1 | Local Tolerability | iritation | 0.00 units on a scale |
| All Participants at Day 1 | Local Tolerability | itchiness | 0.00 units on a scale |
| All Participants at Day 1 | Local Tolerability | burning | 0.00 units on a scale |
| All Participants at Day 1 | Local Tolerability | tenderness | 0.00 units on a scale |
| All Participants at Day 1 | Local Tolerability | pain | 0.00 units on a scale |
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.
Time frame: Day 1 and Day 7
| Arm | Measure | Group | Value (MEDIAN) |
|---|---|---|---|
| All Participants at Day 1 | Skin Infection Rating Scale (SIRS) | SIRS at Day 1 | 10.0 units on a scale |
| All Participants at Day 1 | Skin Infection Rating Scale (SIRS) | SIRS at Day 7 | 1.0 units on a scale |