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

NCT01064947 | Completed Phase 4 Results

• 1 other identifier: ALT113706
• Study Type: interventional
• Target: 29
• Locations: 1 country
• Sites: 1

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.

Conditions

Atopic Dermatitis; Secondary Infection

Outcome Measures

Primary Outcomes (1)

• 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

Secondary Outcomes (3)

• Skin Infection Rating Scale (SIRS)

  Day 1 and Day 7

• Investigator Assessment of Clinical Cure

  Day 7

• Local Tolerability

  Day 7

Interventions

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.

Also known as: Altabax

Eligibility Criteria

• Age: 2 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Derm Research, PLLC: lead
• GlaxoSmithKline: collaborator

Study Sites (1)

DermResearch, PLLC

Louisville, Kentucky, 40217, United States

Location

MeSH Terms

Conditions

Dermatitis, Atopic; Coinfection

Interventions

retapamulin

Condition Hierarchy (Ancestors)

Skin Diseases, Genetic; Genetic Diseases, Inborn; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Dermatitis; Skin Diseases; Skin and Connective Tissue Diseases; Skin Diseases, Eczematous; Hypersensitivity, Immediate; Hypersensitivity; Immune System Diseases; Infections

Limitations and Caveats

small number of subjects/short duration of study treatment

Results Point of Contact

• Title: Leon H. Kircik, M.D.
• Organization: DermResearch, PLLC

wedoderm@yahoo.com

502-451-9000

Study Officials

• Leon H. Kircik, M.D.

  DermResearch, PLLC

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: February 8, 2010
• First Posted: February 9, 2010
• Study Start: February 1, 2010
• Primary Completion: January 1, 2012
• Study Completion: January 1, 2012
• Last Updated: September 22, 2016
• Results First Posted: July 4, 2013

Record last verified: 2013-04

Locations

US (1)