A study to investigate the efficacy of an antimicrobial cream in the treatment of impetigo.

Phase 1

• Conditions: The condition to be studied is uncomplicated localised primary non-bullous impetigo, suitable for topical antibacterial therapy alone.; MedDRA version: 20.0Level: PTClassification code 10021531Term: ImpetigoSystem Organ Class: 10021881 - Infections and infestations; Therapeutic area: Diseases [C] - Skin and Connective Tissue Diseases [C17]

• Registration Number: EUCTR2008-000036-41-GB
• Lead Sponsor: Dermal Laboratories Ltd

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2014-02-21
• Last Update Posted: 13 July 2020

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 242

Inclusion Criteria

i. Male or female patients aged 18 months and over.

ii. Diagnosis of uncomplicated, localised, primary non-bullous (crusted) impetigo considered, by the Investigator, suitable for treatment with topical antibacterial therapy only.

iii. Patients presenting with at least 1, but no more than 10, discrete impetigo lesions.

iv. Patients with a total surface area of impetigo involvement not exceeding 100 cm2 (in the case of patients aged 18 years and above) or not exceeding 2% of the total body surface area (in case of patients younger than 18 years).

Are the trial subjects under 18? yes
Number of subjects for this age range: 162
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 75
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 5

Exclusion Criteria

i) Patients with a history of intolerance or skin sensitivity to any of the ingredients.

ii) Patients with underlying skin disease or trauma with clinical evidence of secondary infection, or a bacterial skin infection that, in the Investigator’s opinion, is not suitable for treatment with topical antibacterial therapy only (e.g. diabetic foot infections, extensive cellulitis, furunculosis, or abscess).

iii) Patients with signs and symptoms of systemic infection (e.g. fever with oral temperature above 38.3ºC).

iv) Patients who have applied any topical therapeutic agent (including corticosteroids, antibacterials and antifungals) directly to the impetigo lesion(s) within 48 hours prior to study entry.

v) Patients who have taken any systemic antibacterial or steroid/corticosteroid treatment within 48 hours prior to study entry.

vi) Patients with systemic diseases which, in the opinion of the Investigator, may adversely influence their participation in the trial.

vii) Patients who have received any unlicensed drug within the last 30 days or who are scheduled to receive an investigative drug other than the study medication during the period of the study.

viii) Patients who are immunocompromised.

ix) Female patients who are pregnant or lactating (although there are no particular safety concerns in these patient groups, it is generally inappropriate for them to participate in clinical trials without overriding justification. Negative pregnancy testing will not be necessary, and there are no safety concerns, as such, about female patients potentially conceiving while taking part in the study).

x) Patients considered unable or unlikely to attend the necessary follow-up visits at day 8 (or day 9 or 10) and potentially day 15 (or day 16 or 17), which are not part of the standard clinical care.

xi) Patients who, in the opinion of the Investigator, have impetigo lesions which may require being covered with gauze, bandages and/or nappies during treatment with the IMP.

xii) Patients with another member of the household participating in the study during the same treatment period (this is to avoid possible mix up between assigned treatments).

xiii) Employees of the Sponsor or the Investigators, or their immediate family members (partner, offspring, parents, siblings or sibling’s offspring).

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified