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

Atopic Dermatitis Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01064947
• Other study ID #: ALT113706
• Status: Completed
• Phase: Phase 4
• First received: February 8, 2010
• Last updated: April 24, 2013
• Start date: February 2010
• Est. completion date: January 2012

Study information

• Verified date: April 2013
• Source: Derm Research, PLLC
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 29
• Est. completion date: January 2012
• Est. primary completion date: January 2012
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 2 Years and older

Eligibility

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.

Study Design

Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Atopic Dermatitis
• Coinfection
• Dermatitis
• Dermatitis, Atopic
• Eczema
• Secondary Infection

Intervention

Drug:
• Retapamulin 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.

Locations

Country	Name	City	State
United States	DermResearch, PLLC	Louisville	Kentucky

Sponsors (2)

Lead Sponsor	Collaborator
Derm Research, PLLC	GlaxoSmithKline

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
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.	Day 1 and Day 7	No
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.	Day 1 and Day 7	No
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	Day 7	No
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.	Day 7	No