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

This study has been completed.
Sponsor:
Collaborator:
GlaxoSmithKline
Information provided by (Responsible Party):
Leon Kircik, M.D., Derm Research, PLLC
ClinicalTrials.gov Identifier:
NCT01064947
First received: February 8, 2010
Last updated: April 24, 2013
Last verified: April 2013
  Purpose

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.


Condition Intervention Phase
Atopic Dermatitis
Secondary Infection
Drug: Retapamulin 1%
Phase 4

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

Resource links provided by NLM:


Further study details as provided by Derm Research, PLLC:

Primary Outcome Measures:
  • Bacteriological Culture [ Time Frame: Day 1 and Day 7 ] [ Designated as safety issue: No ]
    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.


Secondary Outcome Measures:
  • Skin Infection Rating Scale (SIRS) [ Time Frame: Day 1 and Day 7 ] [ Designated as safety issue: No ]
    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.

  • Investigator Assessment of Clinical Cure [ Time Frame: Day 7 ] [ Designated as safety issue: No ]
    The investigator assessed clinical cure at Day 7 as either total or improved cure, failure confirmed or failure by default

  • Local Tolerability [ Time Frame: Day 7 ] [ Designated as safety issue: No ]

    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.



Enrollment: 29
Study Start Date: February 2010
Study Completion Date: January 2012
Primary Completion Date: January 2012 (Final data collection date for primary outcome measure)
Intervention Details:
    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.
    Other Name: Altabax
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

Ages Eligible for Study:   2 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01064947

Locations
United States, Kentucky
DermResearch, PLLC
Louisville, Kentucky, United States, 40217
Sponsors and Collaborators
Derm Research, PLLC
GlaxoSmithKline
Investigators
Principal Investigator: Leon H. Kircik, M.D. DermResearch, PLLC
  More Information

No publications provided

Responsible Party: Leon Kircik, M.D., Principal Investigator, Derm Research, PLLC
ClinicalTrials.gov Identifier: NCT01064947     History of Changes
Other Study ID Numbers: ALT113706
Study First Received: February 8, 2010
Results First Received: April 24, 2013
Last Updated: April 24, 2013
Health Authority: United States: Food and Drug Administration

Additional relevant MeSH terms:
Coinfection
Communicable Diseases
Dermatitis
Dermatitis, Atopic
Infection
Neoplasm Metastasis
Genetic Diseases, Inborn
Hypersensitivity
Hypersensitivity, Immediate
Immune System Diseases
Neoplasms
Neoplastic Processes
Parasitic Diseases
Pathologic Processes
Skin Diseases
Skin Diseases, Eczematous
Skin Diseases, Genetic
Virus Diseases

ClinicalTrials.gov processed this record on October 29, 2014