A Phase II Study to Evaluate the Efficacy and Safety of Two Doses of LTX-109 in Impetigo

NCT01803035 | Completed Phase 2

• 1 other identifier: C12-109-04
• Study Type: interventional
• Target: 210
• Locations: 1 country
• Sites: 2

Brief Summary

The purpose of this study is to determine the efficacy of the topical antibiotic LTX-109 in terms of clinical and microbiological response in treatment of impetigo.

Conditions

Non-bullous Impetigo

Keywords

Impetigo; LTX-109; Topical; Antibiotic; Placebo; Lytic; Peptide; Gram Positive

Outcome Measures

Primary Outcomes (1)

• Efficacy of LTX-109.

  Efficacy of two doses 1% and 2% LTX-109 versus placebo will be measured by clinical response. Clinical response is defined as "Clinical success", "Clinical improvement" and "Clinical failure". Evaluation of the target lesion will be done at day 4, day 6 and day 12 and will be derived from Skin Infection Rating Scale (SIRS).

  One year

Secondary Outcomes (2)

• Safety of topical administration in treatment of impetigo.

  One year

• Microbiological response of two doses of LTX-109 (1% and 2%) versus placebo in the treatment of impetigo.

  One year

Study Arms (3)

1 % LTX-109

EXPERIMENTAL

LTX-109 topical gel in 1 % strength

Drug: LTX-109 1 %

2 % LTX-109

EXPERIMENTAL

LTX-109 topical gel in 2 % strength

Drug: LTX-109 2 %

Placebo

PLACEBO COMPARATOR

Placebo gel, containing all ingredients except LTX-109

Drug: Placebo gel

Interventions

LTX-109 1 % DRUG

1 % LTX-109

LTX-109 2 % DRUG

2 % LTX-109

Placebo gel DRUG

Placebo

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:

• Patients ≥ 2 years of age.
• Signed written informed consent document by patient, parent, legal guardian or caretaker.
• Positive Gram-stain of target lesion showing Gram-positive cocci.
• Clinical diagnosis of primary non-bullous impetigo as per protocol.
• Candidate for treatment with topical antibacterial and have a Skin Infection Rating Scale (SIRS) of ≥ 4 with at least three of the five primary signs and symptoms present at baseline including a score of 1 or greater for exudate/pus.
• Total lesion area ≤ 20 cm2. Single lesion not to exceed 2 cm2.
• No known medical conditions that in the investigators opinion may interfere with study participation or put the patient at additional risk.

You may not qualify if:

• Unwillingness or inability of patient, parent, legal guardian or caretaker to comply with the requirements of the protocol.
• Presence of other skin disease at or near the investigational target area to be treated.
• The disease is so widespread or severe that, in the opinion of the investigator, the patient needs oral antibiotic treatment.
• History of hepatitis B or C, HIV, AIDS, or other immunodeficiency disease.
• Concurrent or recent scabies infection.
• Signs and symptoms of a current infection requiring antibiotic treatment.
• Tympanic temperature at Baseline \> 38 °C (100.4 °F) in a pediatric patient or 37.8 °C (100 °F) in an adult patient.
• Use of systemic or topical antibiotics or steroids within 72 hours prior to study entry.
• Participation in any other clinical study or use of any other investigational drugs or investigational device within 30 days prior to treatment.
• Known allergy to any constituent of the study medication.
• Presence of secondarily-infected animal/human/insect bite or infected burn wound.
• Other reason which based on the discretion of the investigator makes the patient unsuitable for enrolment.
• Lactating or pregnant.

Sponsors & Collaborators

• Lytix Biopharma AS: lead

Study Sites (2)

Dr. Robert Reid Cabral Children Hospital

Santo Domingo, Dominican Republic

Location

Institute of Dermatology and and Skin Surgery Dr. Hubert Bogaert Diaz

Santo Domingo, Dominican Republic

Location

MeSH Terms

Conditions

Impetigo

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

Study Officials

• Daisy M Blanco, MD

  Institute of Dermatology and Skin Surgery, Dr. Hubert Bogaert Diaz, Santo Domingo

  PRINCIPAL INVESTIGATOR

• Josefina Fernandez, MD

  Dr. Robert Reid Cabral Children hospital, Santo Domingo

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 21, 2013
• First Posted: March 4, 2013
• Study Start: February 1, 2013
• Primary Completion: March 1, 2014
• Study Completion: April 1, 2014
• Last Updated: April 28, 2014

Record last verified: 2014-04

Locations

DO (2)