Safety and Efficacy Study of Altabax Ointment in the Treatment of Secondarily Infected Atopic Dermatitis

• Status: Completed
• Trial end date: 2012-01-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Derm Research, PLLC
• Collaborator: GlaxoSmithKline
• Treatments: Retapamulin

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.