Safety and Efficacy Study of Altabax Ointment in the Treatment of Secondarily Infected Atopic Dermatitis
Condition: Atopic Dermatitis; Secondary Infection
MeSH terms: Infections; Coinfection; Neoplasm Metastasis; Dermatitis, Atopic; Dermatitis; Eczema
Intervention: Retapamulin 1%
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.
Intervention MeSH terms: Retapamulin
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 29.0
Sex: All
Minimum age: 2 Years
Healthy volunteers: No

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.
    

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.