Trial Outcomes & Findings for Efficacy and Safety of Ozenoxacin 1% Cream Versus Placebo in the Treatment of Patients With Impetigo (NCT NCT01397461)

Last Updated: 2016-07-01

Results Overview

Clinical response (clinical success or clinical failure) at end of therapy (Visit 3) in the intent to treat clinical (ITTC) population. Clinical succes at Visit 3 was defined as: SIRS score 0 for exudates/pus, crusting, tissue warmth and pain and no more than 1 each for erythema/inflammation, tissue edema and itching such that no additional antimicrobial therapy in the baseline (Visit 1) affected area is necessary. The SIRS is a severity index based on seven signs or symptoms: * Exudate/pus * Crusting * Erythema/inflammation * Tissue warmth * Tissue oedema * Itching * Pain Each sign/symptom is rated on a scale from 0 to 6: 0 = absent 1 2 = mild 3 4 = moderate 5 6 = severe

Recruitment status

COMPLETED

Study phase

PHASE3

Target enrollment

465 participants

Primary outcome timeframe

2 weeks

Results posted on

2016-07-01

Participant Flow

Patients were enrolled at 27 sites in the USA, Germany, Romania, Ukraine, and South Africa.

Participant milestones

Participant milestones
Measure	Ozenoxacin 1% Cream 1% cream ozenoxacin 1% cream: 1% cream	Ozenoxacin Placebo cream ozenoxacin placebo: cream	Retapamulin 1% Ointment 1% ointment retapamulin 1% ointment: ointment
Overall Study STARTED	155	156	154
Overall Study COMPLETED	153	150	152
Overall Study NOT COMPLETED	2	6	2

Reasons for withdrawal

Reasons for withdrawal
Measure	Ozenoxacin 1% Cream 1% cream ozenoxacin 1% cream: 1% cream	Ozenoxacin Placebo cream ozenoxacin placebo: cream	Retapamulin 1% Ointment 1% ointment retapamulin 1% ointment: ointment
Overall Study Withdrawal by Subject	2	1	0
Overall Study Lost to Follow-up	0	2	1
Overall Study Lack of Efficacy	0	3	0
Overall Study Not treated	0	0	1

Baseline Characteristics

Efficacy and Safety of Ozenoxacin 1% Cream Versus Placebo in the Treatment of Patients With Impetigo

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Ozenoxacin 1% Cream n=156 Participants 1% cream ozenoxacin 1% cream: 1% cream	Ozenoxacin Placebo n=156 Participants cream ozenoxacin placebo: cream	Retapamulin 1% Ointment n=152 Participants 1% ointment retapamulin 1% ointment: ointment	Total n=464 Participants Total of all reporting groups
Age, Customized 2>=years to <12 years	95 Participants n=99 Participants	94 Participants n=107 Participants	94 Participants n=206 Participants	283 Participants n=7 Participants
Age, Customized >=12 years to <18 years	19 Participants n=99 Participants	18 Participants n=107 Participants	15 Participants n=206 Participants	52 Participants n=7 Participants
Age, Customized >=18 years to <65 years	36 Participants n=99 Participants	40 Participants n=107 Participants	40 Participants n=206 Participants	116 Participants n=7 Participants
Age, Customized >=65	6 Participants n=99 Participants	4 Participants n=107 Participants	3 Participants n=206 Participants	13 Participants n=7 Participants
Sex: Female, Male Female	56 Participants n=99 Participants	60 Participants n=107 Participants	62 Participants n=206 Participants	178 Participants n=7 Participants
Sex: Female, Male Male	100 Participants n=99 Participants	96 Participants n=107 Participants	90 Participants n=206 Participants	286 Participants n=7 Participants
Race/Ethnicity, Customized Black or African American	78 Participants n=99 Participants	77 Participants n=107 Participants	78 Participants n=206 Participants	233 Participants n=7 Participants
Race/Ethnicity, Customized White	58 Participants n=99 Participants	62 Participants n=107 Participants	50 Participants n=206 Participants	170 Participants n=7 Participants
Race/Ethnicity, Customized Mixed race	19 Participants n=99 Participants	15 Participants n=107 Participants	22 Participants n=206 Participants	56 Participants n=7 Participants
Race/Ethnicity, Customized Asian	1 Participants n=99 Participants	0 Participants n=107 Participants	2 Participants n=206 Participants	3 Participants n=7 Participants
Race/Ethnicity, Customized American Indian or Alaska native	0 Participants n=99 Participants	2 Participants n=107 Participants	0 Participants n=206 Participants	2 Participants n=7 Participants

PRIMARY outcome

Timeframe: 2 weeks

Outcome measures

Outcome measures
Measure	Ozenoxacin 1% Cream n=155 Participants 1% cream ozenoxacin 1% cream: 1% cream	Ozenoxacin Placebo n=156 Participants cream ozenoxacin placebo: cream	Retapamulin 1% Ointment n=154 Participants 1% ointment retapamulin 1% ointment: ointment
Clinical Success	34.8 percentage of participants	19.2 percentage of participants	37.7 percentage of participants

Adverse Events

Ozenoxacin 1% Cream

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Ozenoxacin Placebo

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Retapamulin 1% Ointment

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

Clinical Research Manager

Ferrer Internacional, S.A.

Phone: +34 93 509 32 75

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee Any and all data resulting from the Study will not be presented or published in any form or media by the Institution, Investigator or Research Staff without the prior written consent of Sponsor which consent maybe as directed within the Protocol.
Publication restrictions are in place

Restriction type: OTHER