Trial Outcomes & Findings for Efficacy and Safety of Ozenoxacin 1% Cream Versus Placebo in the Treatment of Patients With Impetigo (NCT NCT02090764)
NCT ID: NCT02090764
Last Updated: 2024-08-20
Results Overview
Clinical response (clinical success or clinical failure) at end of therapy (Visit 3) in the intent to treat clinical (ITTC) population. Clinical success at V3 was defined as: SIRS score 0 for blistering, exudates/pus, crusting and itching/pain and no more than 1 for erythema/inflammation such that no additional antimicrobial therapy in the baseline (Visit 1) affected area is necessary. The skin infection rating scale (SIRS) is a severity index based on five signs or symptoms: blistering, exudate/pus, crusting, erythema/inflammation, itching/pain.
COMPLETED
PHASE3
412 participants
Visit 3 (Day 6-7)
2024-08-20
Participant Flow
Patients were enrolled at 34 sites in Germany, Puerto Rico, Romania, Russia, South Africa, Spain and the United States of America (USA).
Participant milestones
| Measure |
Ozenoxacin
ozenoxacin cream 1%
Ozenoxacin
|
Placebo
Placebo cream
Placebo
|
|---|---|---|
|
Overall Study
STARTED
|
206
|
206
|
|
Overall Study
COMPLETED
|
200
|
186
|
|
Overall Study
NOT COMPLETED
|
6
|
20
|
Reasons for withdrawal
| Measure |
Ozenoxacin
ozenoxacin cream 1%
Ozenoxacin
|
Placebo
Placebo cream
Placebo
|
|---|---|---|
|
Overall Study
Adverse Event
|
1
|
3
|
|
Overall Study
Lack of Efficacy
|
0
|
13
|
|
Overall Study
Withdrawal by Subject
|
2
|
1
|
|
Overall Study
Intercurrent illness and other
|
1
|
1
|
|
Overall Study
Lost to Follow-up
|
2
|
2
|
Baseline Characteristics
Efficacy and Safety of Ozenoxacin 1% Cream Versus Placebo in the Treatment of Patients With Impetigo
Baseline characteristics by cohort
| Measure |
Ozenoxacin
n=206 Participants
ozenoxacin cream 1%
Ozenoxacin
|
Placebo
n=205 Participants
Placebo cream
Placebo
|
Total
n=411 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Customized
>=18 years
|
69 participants
n=5 Participants
|
70 participants
n=7 Participants
|
139 participants
n=5 Participants
|
|
Age, Customized
>=12 years to <18 years
|
23 participants
n=5 Participants
|
23 participants
n=7 Participants
|
46 participants
n=5 Participants
|
|
Age, Customized
>= 2 months to <12 years
|
114 participants
n=5 Participants
|
112 participants
n=7 Participants
|
226 participants
n=5 Participants
|
|
Sex: Female, Male
Female
|
94 Participants
n=5 Participants
|
107 Participants
n=7 Participants
|
201 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
112 Participants
n=5 Participants
|
98 Participants
n=7 Participants
|
210 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Caucasian
|
122 participants
n=5 Participants
|
139 participants
n=7 Participants
|
261 participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Black
|
53 participants
n=5 Participants
|
38 participants
n=7 Participants
|
91 participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Asian
|
16 participants
n=5 Participants
|
15 participants
n=7 Participants
|
31 participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Mixed Race
|
15 participants
n=5 Participants
|
13 participants
n=7 Participants
|
28 participants
n=5 Participants
|
|
Region of Enrollment
Puerto Rico
|
23 participants
n=5 Participants
|
23 participants
n=7 Participants
|
46 participants
n=5 Participants
|
|
Region of Enrollment
Germany
|
21 participants
n=5 Participants
|
16 participants
n=7 Participants
|
37 participants
n=5 Participants
|
|
Region of Enrollment
Romania
|
26 participants
n=5 Participants
|
26 participants
n=7 Participants
|
52 participants
n=5 Participants
|
|
Region of Enrollment
Russian Federation
|
27 participants
n=5 Participants
|
30 participants
n=7 Participants
|
57 participants
n=5 Participants
|
|
Region of Enrollment
South Africa
|
43 participants
n=5 Participants
|
34 participants
n=7 Participants
|
77 participants
n=5 Participants
|
|
Region of Enrollment
Spain
|
1 participants
n=5 Participants
|
2 participants
n=7 Participants
|
3 participants
n=5 Participants
|
|
Region of Enrollment
United States
|
65 participants
n=5 Participants
|
74 participants
n=7 Participants
|
139 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Visit 3 (Day 6-7)Population: Intent-to-treat clinical (ITTC) population was defined as all randomized patients. The % of clinical success for the treatment comparison were calculated excluding the unable to determine: OZN (112/203), PLB (78/199)
Clinical response (clinical success or clinical failure) at end of therapy (Visit 3) in the intent to treat clinical (ITTC) population. Clinical success at V3 was defined as: SIRS score 0 for blistering, exudates/pus, crusting and itching/pain and no more than 1 for erythema/inflammation such that no additional antimicrobial therapy in the baseline (Visit 1) affected area is necessary. The skin infection rating scale (SIRS) is a severity index based on five signs or symptoms: blistering, exudate/pus, crusting, erythema/inflammation, itching/pain.
Outcome measures
| Measure |
Ozenoxacin
n=203 Participants
ozenoxacin cream 1%
Ozenoxacin
|
Placebo
n=199 Participants
Placebo cream
Placebo
|
|---|---|---|
|
Clinical Success
|
55.2 percentage of Participants
|
39.2 percentage of Participants
|
Adverse Events
Ozenoxacin
Placebo
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.
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