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Anti-Infective Agents

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Retapamulin

Anti-Bacterial Agents

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.

Retapamulin 1%

Leon H. Kircik, M.D.

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.

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.

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

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

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.

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.

The investigator assessed clinical cure at Day 7 as either total or improved cure, failure confirmed or failure by default

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.

GlaxoSmithKline

Derm Research, PLLC

Principal Investigator

All consented subjects with a suspected secondary infection of atopic dermatitis were cultured.The treatment of Retapamulin 1% was started , with a thin layer applied twice daily and covered with gauze (if desired) for 7 days. The subject treatment site was cultured after 7 days of treatment.

All Participants

Age, Continuous

Sex: Female, Male

United States

Region of Enrollment

Baseline characteristics are provided only for those subjects with a positive culture

small number of subjects/short duration of study treatment

S. aureus (MRSA)

S. aureus (MSSA)

S. pyogenes

All consented subjects with an apparent secondary infection were cultured.The treatment of Retapamulin 1% was started , with a thin layer applied twice daily and covered with gauze (if necessary) for 7 days. The subject treatment site was cultured after 7 days of treatment.

All Participants at Day 1

Participants With a Positive Culture at Day 1

Bacteriological Culture

SIRS at Day 1

SIRS at Day 7

Participants With Positive Culture at Day 1

Skin Infection Rating Scale (SIRS)

clinical cure total

clinical cure improved

failure - confirmed and default

Investigator Assessment of Clinical Cure

erythema

crusting

necrosis

inflammation

swelling

infection

peeling

contact dermatitis

iritation

itchiness

burning

tenderness

pain

Local Tolerability

All consented subjects with an apparent secondary infection were cultured.The treatment of Retapamulin 1% was started , with a thin layer applied twice daily and covered with gauze (if desired) for 7 days. The subject treatment site was cultured after 7 days of treatment.

Overall Study

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization	Link
Safety and Efficacy Study of Altabax Ointment in the Treatment of Secondarily Infected Atopic Dermatitis	NCT01064947	Atopic Dermatit... Secondary Infec...	Retapamulin 1%	2 Years -	Derm Research, PLLC
Safety and Efficacy Study of Altabax Ointment in the Treatment of Secondarily Infected Atopic Dermatitis	NCT01064947	Atopic Dermatit... Secondary Infec...	Retapamulin 1%	2 Years -	Derm Research, PLLC

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