None listed
Conditions
Interventions
GROUP 1 Type of group
This group will be treated with Mupirocin 2% topical ointment (Glenmark Pharmaceuticals) TID, applied to the affected areas for 7 days.
Group name:GROUP 3 Type of group
This group will be treated with a Vehicle Ointment. TID, applied to the affected areas for 7 days.
Sponsors
Glemmark Pharnaceuticals. INC,
Eligibility
Inclusion criteria
Inclusion criteria: 1. Complete an Informed Consent Process, including signature and date of an Informed Consent Form. In the case of minors, it will be necessary for their parent or guardian to sign the Informed Consent Form. The subjects will give their assent in writing whenever possible. 2. All female subjects who are of reproductive age should have a negative urine pregnancy test and commit to abstinence, or use prescription contraceptives and use a contraceptive barrier device along with a spermicidal product throughout the entire duration of the study. 3. The subject is voluntary and able to meet the requirements of the study. 4. The subject has a diagnosis of impetigo. 5. The subject has a score of> 8 on the SIRS Cutaneous Infection Scale which is based on the sum of individual Blister scores, Exudate / Pus, Crust, Erythema / Inflammation, and Itch / Pain.
Exclusion criteria
Exclusion criteria: 1. The subject must not be less than 18 months of age at the time of enroll. 2. The woman who is the subject of the study should not be pregnant or breastfeeding, nor should she plan to become pregnant during the study period. 3. Subjects with extended blister impetigo, cellulitis, furunculosis, abscesses and chronic dermatitis should be excluded from the study. Subjects with more than three lesions should be evaluated to determine if topical therapy is appropriate. 4. Subjects with lesions secondary infections caused by animal, trauma, or surgery will be excluded. 5. Subjects who have used a test should be excluded from the study. topical or systemic or antimicrobial antibiotic, or antibacterial soap within 24 hours. 6. Subjects with a history of renal failure or active kidney disease should be excluded from the study. 7. Any subject with a documented history of hypersensitivity to the investigational mupirocin product, other related agents, or who knows that he / she is allergic, hypersensitive, or for some other reason intolerant to any one, should be excluded from the study. component of the study medications. 8. The subject should not be taking any cytotoxic, cytostatic or immunosuppressive agent, within 30 days before enrolling in the study. 9. All subjects with a history of treatment for alcohol or drug abuse within the last year should be excluded from the study. 10. The presence of any condition for which the therapy with the research product is clinically contraindicated, or of any condition that prevents the subject from participating in the study. 11. The subject must not have taken any experimental or investigational drug within 30 days before enrolling.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Outcome name:Clinical evaluation, in which the SIRS Scale will be applied. Cutaneous infection which evaluates the following signs / symptoms: Blisters, Exudate / pus, Crusts, Erythema / inflammation, Itching / Pain. A score of 0-6 is assigned to the result (0 = absent, 2 = mild, 4 = moderate, 6 = severe). Measure:Index of clinical cure in the visit of Test of Cure. Timepoints:Visit 4: Day 14 ± 3. | — |
Secondary
| Measure | Time frame |
|---|---|
| Outcome name:Clinical evaluation of adverse events, as well as their classification according to their severity and degree of relationship with the study treatment. There will also be a complete physical examination with evaluation of vital signs Measure:Safety of the treatment: Incidence of adverse events, alterations in the physical examination and vital signs. Timepoints:Adverse events: Visits 2 (Day 3 ± 2), 3 (Day 7 ± 2) and 4 (Day 14 ± 3). Physical examination and vital signs: Before starting treatment and at visit 4 (Day 14 ± 3). ; Outcome name:1) Index of Clinical Healing: Clinical evaluation, in which the SIRS Scale of Cutaneous Infection will be applied which evaluates the following signs / symptoms: Ampoules, Exudate / pus, Crusts, Erythema / inflammation, Itching / Pain. A score of 0-6 is assigned to the result (0 = absent, 2 = mild, 4 = moderate, 6 = severe). 2) Bacteriological cure index: Absence of Staphylococcus aureus and Streptococcus pyogenes in cultures of white lesions. Measure:Secondary efficacy: 1) Index of Clinical Healing at the End of Treatment. 2) Bacteriological Cure Index in the End of Treatment and Cure Test visits. Timepoints:End of Treatment Visit / Visit 3: Day 7 ± 2 days. Visit Cure Test / Visit 4: Day 14 ± 3. | — |
Outcome results
None listed