Impetigo Clinical Trial
Official title:
Efficacy, Safety and Tolerability of TD1414 2% Cream in Impetigo and Secondarily Infected Traumatic Lesions (SITL)
NCT number | NCT00626795 |
Other study ID # | TD1414-C21 |
Secondary ID | |
Status | Completed |
Phase | Phase 2 |
First received | |
Last updated | |
Start date | February 2008 |
Est. completion date | June 2009 |
Verified date | August 2018 |
Source | LEO Pharma |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
An international, multi-centre, prospective three arm parallel-group, phase II proof of concept study comparing the efficacy and safety of two dosage regimens (BID 7 days and TID 7 days) of TD1414 2% cream and one dosage regimen (BID 7 days) of Bactroban® (mupirocin) 2% cream in adults and children down to 2 years of age with impetigo or SITL. Furthermore an evaluation of the pharmacokinetics of TD1414 2% cream TID for 7 days will be performed. A total of 664 patients will be enrolled in a stepwise manner according to age groups starting with the oldest age group.
Status | Completed |
Enrollment | 773 |
Est. completion date | June 2009 |
Est. primary completion date | March 2009 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 2 Years and older |
Eligibility |
Inclusion Criteria: - Signed and dated informed consent from patient and/or legally acceptable representative has been obtained - Outpatients of any sex or ethnic origin - Patients >= 2 years of age (depending on study step) - Patients must be suffering from primary bullous/non-bullous impetigo or SITL Exclusion Criteria: - Presence of skin diseases at or near the investigational area - Immunosuppressed state or other serious systemic disease - Signs and/or symptoms of systemic infection - Presence of skin infection/disorder not amenable to topical antibacterial treatment only - Presence of secondarily-infected animal/human bite - Presence of secondarily infected burnwound - Topical or systemic use of medicinal or other products before or during the study which in the investigators opinion could confound the evaluation of the effect of the study drugs - Known or suspected hypersensitivity to TD1414 or any of the excipients in the TD1414 2% cream - Known or suspected hypersensitivity to mupirocin or any of the excipients in the Bactroban® (mupirocin) 2% cream - Participation in any other investigational drug study or use of (an) investigational drug(s) within the 30 days or 5 half-lives (whichever is longer) prior to randomisation - Patients previously enrolled/randomised in this study - Abnormal ECG at baseline though the PR interval may be up to 220 ms, the QRS interval up to 110 ms and the QTc interval up to 450 ms |
Country | Name | City | State |
---|---|---|---|
South Africa | Division of Dermatology, Groote Schuur Hospital, G23 | Cape Town | Western Cape |
United States | Anniston Medical Clinic | Anniston | Alabama |
Lead Sponsor | Collaborator |
---|---|
LEO Pharma |
United States, South Africa,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Participants With Clinical Cure According to Investigator's Assessment | At end of treatment (Day 8), the participants had their impetigo/Secondarily Infected Traumatic Lesions (SITL) evaluated by the (sub)investigator. Investigator's assessment of severity of infections (SIRS). Exudates/pus Crusting Erythema Oedema Tissue Warmth Itching Pain Each sign/symptoms of infection was assessed by use of the following 4-point scale: 0 = absent 2 = mild 4 = moderate 6 = severe The scores were summed up to a total SIRS score. Clinical cure was either of the following: Total absence of signs and symptoms of impetigo/SITL OR Improvement - total SIRS score reduced to <8 and all individual clinical signs/symptoms included in the SIRS score should have been =4. Clinical failure was either of the following: Signs and symptoms of impetigo/SITL that did not meet the definition of clinical cure Unable to determine (e.g. participants who refuse clinical examination or did not show at end of treatment or follow-up). |
At end of treatment (Day 8) | |
Secondary | Participants With Clinical Cure According to Investigator's Assessment | At follow up (Day 15), the participants had their impetigo/SITL evaluated by the (sub)investigator. | At follow up (Day 15) | |
Secondary | Participants With Clinical Cure According to Investigator's Assessment. | At end of treatment (Day 8) and at follow-up (Day 15), the participants had their impetigo/SITL evaluated by the (sub)investigator. | At end of treatment (Day 8) and follow-up (Day 15) | |
Secondary | Participants With Bacteriological Cure According to Bacteriological Samples | At baseline (Day 1), end of treatment (EOT), and follow-up (FU), the investigator obtained a bacteriological sample to base the assessment on. Bacteriological cure was either of the following: Eradication of the baseline pathogen. Presumed eradication of the baseline pathogen Infection with a pathogen different from the baseline pathogen at EOT or FU and the participant was NOT symptomatic. Bacteriological failure was any of the following: Documented lack of eradication of the baseline pathogen. Documented relapse (re-infection) with the baseline pathogen Documented super-infection, i.e. infection with a pathogen different from the baseline pathogen at EOT or FU, and the participants was symptomatic Presumed persistence of baseline pathogen: Non-evaluable participants- participants who refused bacteriological examination or did not show at EOT or FU, and clinical failures who had no bacteriological sample to rule out bacterial infection. |
At end of treatment (Day 8), follow-up (Day 15) and end of treatment and follow-up | |
Secondary | Participants With Clinical and Bacteriological Cure According to Investigator's Assessment and Bacteriological Samples | At end of treatment (Day 8) and at follow-up (Day 15) the participants had their impetigo/SITL evaluated by the (sub)investigator. At baseline (Day 1), end of treatment (Day 8) and at follow-up (Day 15) the investigator obtained a bacteriological sample on which an assessment of bacteriological cure was based. |
At end of treatment (Day 8), follow-up (Day 15) and end of treatment and follow-up | |
Secondary | Participants With Clinical Cure According to Investigator's Assessment | At Day 4 the participants had their impetigo/SITL evaluated by the (sub)investigator. | At Day 4 |
Status | Clinical Trial | Phase | |
---|---|---|---|
Completed |
NCT00884728 -
Evaluation of a Regional Healthy Skin Program in Remote Aboriginal Communities of Australia's Northern Territory
|
N/A | |
Completed |
NCT02902822 -
Tele-dermatology of Skin Cancer in a Cohort of Local Health Authority Employees in the Province of Bergamo
|
N/A | |
Completed |
NCT01153828 -
EU PV for Retapamulin-Prescribing
|
N/A | |
Active, not recruiting |
NCT05226260 -
Decreasing Antibiotic Duration for Skin and Soft Tissue Infection Using Behavioral Economics in Primary Care
|
N/A | |
Terminated |
NCT00986856 -
Fucidin® Cream in the Treatment of Impetigo
|
Phase 4 | |
Completed |
NCT01397461 -
Efficacy and Safety of Ozenoxacin 1% Cream Versus Placebo in the Treatment of Patients With Impetigo
|
Phase 3 | |
Recruiting |
NCT02090764 -
Efficacy and Safety of Ozenoxacin 1% Cream Versus Placebo in the Treatment of Patients With Impetigo
|
Phase 3 | |
Completed |
NCT02775617 -
Azithromycin - Ivermectin Mass Drug Administration for Skin Disease
|
Phase 4 | |
Not yet recruiting |
NCT01611909 -
Citriodiol® and Impetigo
|
Phase 2/Phase 3 | |
Completed |
NCT03177993 -
Fiji Integrated Therapy (FIT) - Triple Therapy for Lymphatic Filariasis, Scabies and Soil Transmitted Helminths in Fiji
|
N/A | |
Completed |
NCT03429595 -
Study Evaluating the Safety, Tolerability, PK, and Activity of Topical ATx201 Gel in Outpatients With Impetigo
|
Phase 2 | |
Completed |
NCT04287777 -
Safety and Efficacy of Mupirocin Gel in Children With Impetigo
|
Phase 3 | |
Completed |
NCT00758862 -
The Pharmacokinetics of 2% TD1414 Cream in Adults With Secondarily Infected Traumatic Lesions (SITL) or Impetigo
|
Phase 2 | |
Recruiting |
NCT01943136 -
The Efficacy and Safety of Topical Papaya (Carica Papaya) Leaf Extract 1% Ointment Versus Mupirocin 2% Ointment in the Treatment of Limited Impetigo: a Randomized, Double-blind, Controlled Clinical Trial
|
Phase 1 | |
Completed |
NCT01670032 -
Vehicle Controlled Efficacy and Safety Study of Two Dose Regimens of CD07223 1.5% Topical Gel in Impetigo
|
Phase 2/Phase 3 | |
Completed |
NCT01171326 -
Study to Evaluate the Safety and Efficacy of Topical Minocycline FXFM244 in Impetigo Patients
|
Phase 2 | |
Completed |
NCT01367314 -
Safety and Efficacy of Topical NVC-422 Gel in Impetigo
|
Phase 2 | |
Completed |
NCT01126268 -
Twice Daily Altabax Application for the Treatment of Uncomplicated Soft Tissue Infection
|
Phase 4 | |
Completed |
NCT00852540 -
Retapamulin Versus Linezolid in the Treatment of SITL and Impetigo Due to MRSA
|
Phase 3 | |
Completed |
NCT00133848 -
Treatment Of Impetigo With Topical SB-275833 Ointment, 1% Versus Topical Placebo Ointment
|
Phase 3 |