Clinical trial NCT01064947: 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
Overall status: COMPLETED
Phase: PHASE4
Conditions: Atopic Dermatitis
Secondary Infection
Lead sponsor: Derm Research, PLLC
Sponsor class: OTHER
Collaborators: name: GlaxoSmithKline
First posted: 2010-02-09
Enrollment: 29
Sex: ALL
Minimum age (years): 2
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.

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.

Primary outcomes:
measure: Bacteriological Culture
timeFrame: Day 1 and Day 7
Secondary outcomes:
measure: Skin Infection Rating Scale (SIRS)
timeFrame: Day 1 and Day 7
measure: Investigator Assessment of Clinical Cure
timeFrame: Day 7
measure: Local Tolerability
timeFrame: Day 7
Other outcomes:
Locations:
city: Louisville
country: United States
facility: DermResearch, PLLC
state: Kentucky
Study officials:
affiliation: DermResearch, PLLC
name: Leon H. Kircik, M.D.
role: PRINCIPAL_INVESTIGATOR
References: