Safety and Efficacy Study of Altabax Ointment in the Treatment of Secondarily Infected Atopic Dermatitis
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|ClinicalTrials.gov Identifier: NCT01064947|
Recruitment Status : Completed
First Posted : February 9, 2010
Results First Posted : July 4, 2013
Last Update Posted : September 22, 2016
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 or disease||Intervention/treatment||Phase|
|Atopic Dermatitis Secondary Infection||Drug: Retapamulin 1%||Phase 4|
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.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||29 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|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|
|Study Start Date :||February 2010|
|Actual Primary Completion Date :||January 2012|
|Actual Study Completion Date :||January 2012|
- 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
- Bacteriological Culture [ Time Frame: Day 1 and Day 7 ]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.
- Skin Infection Rating Scale (SIRS) [ Time Frame: Day 1 and Day 7 ]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 ]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 ]
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.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01064947
|United States, Kentucky|
|Louisville, Kentucky, United States, 40217|
|Principal Investigator:||Leon H. Kircik, M.D.||DermResearch, PLLC|