Efficacy, Safety, and Tolerability of TD1414 2% Cream in Impetigo and Secondarily Infected Traumatic Lesions (SITL)

NCT00626795 | Completed Phase 2 Results DMC

• 1 other identifier: TD1414-C21
• Study Type: interventional
• Target: 773
• Locations: 2 countries
• Sites: 2

Brief Summary

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.

Conditions

Impetigo; Secondarily Infected Traumatic Lesions

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (5)

• Participants With Clinical Cure According to Investigator's Assessment

  At follow up (Day 15)

• Participants With Clinical Cure According to Investigator's Assessment.

  At end of treatment (Day 8) and follow-up (Day 15)

• Participants With Bacteriological Cure According to Bacteriological Samples

  At end of treatment (Day 8), follow-up (Day 15) and end of treatment and follow-up

• Participants With Clinical and Bacteriological Cure According to Investigator's Assessment and Bacteriological Samples

  At end of treatment (Day 8), follow-up (Day 15) and end of treatment and follow-up

• Participants With Clinical Cure According to Investigator's Assessment

  At Day 4

Study Arms (3)

1

EXPERIMENTAL

Drug: TD1414 2% cream

2

EXPERIMENTAL

Drug: TD1414 2% cream

3

ACTIVE COMPARATOR

Drug: Bactroban® (mupirocin) 2% cream

Interventions

TD1414 2% cream DRUG

BID 7 days

1

Bactroban® (mupirocin) 2% cream DRUG

BID 7 days

3

Eligibility Criteria

• Age: 2 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• LEO Pharma: lead

Study Sites (2)

Anniston Medical Clinic

Anniston, Alabama, 36207, United States

Location

Division of Dermatology, Groote Schuur Hospital, G23

Cape Town, Western Cape, 7925, South Africa

Location

MeSH Terms

Conditions

Impetigo

Interventions

Mupirocin

Condition Hierarchy (Ancestors)

Staphylococcal Skin Infections; Staphylococcal Infections; Gram-Positive Bacterial Infections; Bacterial Infections; Bacterial Infections and Mycoses; Infections; Streptococcal Infections; Skin Diseases, Bacterial; Skin Diseases, Infectious; Skin Diseases; Skin and Connective Tissue Diseases

Intervention Hierarchy (Ancestors)

Epoxy Compounds; Ethers, Cyclic; Ethers; Organic Chemicals; Pyrans; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Fatty Acids; Lipids

Results Point of Contact

• Title: Clinical Trial Disclosure Manager
• Organization: LEO Pharma A/S

disclosure@leo-pharma.com

+45 4494 5888

Study Officials

• Almena L Free, MD

  Anniston Medical Clinic

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 21, 2008
• First Posted: February 29, 2008
• Study Start: February 1, 2008
• Primary Completion: March 1, 2009
• Study Completion: June 1, 2009
• Last Updated: March 12, 2025
• Results First Posted: July 23, 2018

Record last verified: 2018-08

Data Sharing

• IPD Sharing: Will not share

Locations

US (1); ZA (1)