Trial Outcomes & Findings for Safety and Efficacy Study of Altabax Ointment in the Treatment of Secondarily Infected Atopic Dermatitis (NCT NCT01064947)

Last Updated: 2016-09-22

Results Overview

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.

Recruitment status

COMPLETED

Study phase

PHASE4

Target enrollment

29 participants

Primary outcome timeframe

Day 1 and Day 7

Results posted on

2016-09-22

Participant Flow

Subjects with suspected secondarily infected atopic dermatitis were recruited from the investigator's medical practice. Recruitment occurred from July 2010 through November 2011

Seventy subjects were enrolled into the study. Of these 29 had a positive culture for s. aureus (MRSA and MSSA) or S. pyogenes

Participant milestones

Participant milestones
Measure	All Participants 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 STARTED	70
Overall Study COMPLETED	29
Overall Study NOT COMPLETED	41

Reasons for withdrawal

Reasons for withdrawal
Measure	All Participants 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 negative culture	41

Baseline Characteristics

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

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	All Participants n=29 Participants 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.
Age, Continuous	36.6 years n=99 Participants
Sex: Female, Male Female	20 Participants n=99 Participants
Sex: Female, Male Male	9 Participants n=99 Participants
Region of Enrollment United States	29 participants n=99 Participants

PRIMARY outcome

Timeframe: 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.

Outcome measures

Outcome measures
Measure	All Participants at Day 1 n=70 Participants 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.	Participants With a Positive Culture at Day 1 n=29 Participants
Bacteriological Culture S. pyogenes	0 participants	0 participants
Bacteriological Culture S. aureus (MSSA)	16 participants	5 participants
Bacteriological Culture S. aureus (MRSA)	13 participants	3 participants

SECONDARY outcome

Timeframe: 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.

Outcome measures

Outcome measures
Measure	All Participants at Day 1 n=29 Participants 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.	Participants With a Positive Culture at Day 1
Skin Infection Rating Scale (SIRS) SIRS at Day 1	10.0 units on a scale Interval 9.0 to 12.0	—
Skin Infection Rating Scale (SIRS) SIRS at Day 7	1.0 units on a scale Interval 1.0 to 3.0	—

SECONDARY outcome

Timeframe: Day 7

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

Outcome measures

Outcome measures
Measure	All Participants at Day 1 n=29 Participants 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.	Participants With a Positive Culture at Day 1
Investigator Assessment of Clinical Cure clinical cure improved	15 participants	—
Investigator Assessment of Clinical Cure clinical cure total	12 participants	—
Investigator Assessment of Clinical Cure failure - confirmed and default	2 participants	—

SECONDARY outcome

Timeframe: 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.

Outcome measures

Outcome measures
Measure	All Participants at Day 1 n=29 Participants 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.	Participants With a Positive Culture at Day 1
Local Tolerability erythema	1.00 units on a scale Interval 0.0 to 1.0	—
Local Tolerability crusting	0.00 units on a scale Interval 0.0 to 1.0	—
Local Tolerability necrosis	0.00 units on a scale Interval 0.0 to 0.0	—
Local Tolerability inflammation	0.00 units on a scale Interval 0.0 to 0.0	—
Local Tolerability swelling	0.00 units on a scale Interval 0.0 to 0.0	—
Local Tolerability infection	0.00 units on a scale Interval 0.0 to 0.0	—
Local Tolerability peeling	0.00 units on a scale Interval 0.0 to 0.0	—
Local Tolerability contact dermatitis	0.00 units on a scale Interval 0.0 to 0.0	—
Local Tolerability iritation	0.00 units on a scale Interval 0.0 to 0.0	—
Local Tolerability itchiness	0.00 units on a scale Interval 0.0 to 1.0	—
Local Tolerability burning	0.00 units on a scale Interval 0.0 to 0.0	—
Local Tolerability tenderness	0.00 units on a scale Interval 0.0 to 0.0	—
Local Tolerability pain	0.00 units on a scale Interval 0.0 to 0.0	—

Adverse Events

All Participants

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Leon H. Kircik, M.D.

DermResearch, PLLC

Phone: 502-451-9000

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place