Efficacy and Safety of Acyclovir Lipstick (Contra) in Treatment of Skin Infections Provoked by Herpes Simplex

• Conditions: History of recurrent herpes labialis with at least 3 recurrences during the past 12 months and typically (>50% of episodes) associated with prodromal symptoms; MedDRA version: 14.1Level: LLTClassification code 10019942Term: Herpes labialisSystem Organ Class: 10021881 - Infections and infestations; Therapeutic area: Diseases [C] - Virus Diseases [C02]

• Registration Number: EUCTR2011-002135-26-IT
• Lead Sponsor: AESCULAPIUS FARMACEUTICI S.R.L.

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2011-12-27
• Last Update Posted: 7 January 2013

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: Not specified

Inclusion Criteria

- Caucasian origin; - Patients with a clinical diagnosis of active infection of recurrent labial herpes in prodromal phase; - Body weight within 20% of ideal body weight; - Normal physical examination, vital signs, ECG; - Negative result of pregnancy test for female patients.
Are the trial subjects under 18? no
Number of subjects for this age range: 0
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 50
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 20

Exclusion Criteria

? Recent infection of Herpes Zoster in the last 4 weeks; ? Treatment with other systemic or topical antiviral agents or systemic corticosteroids within 4 weeks prior to study drug administration; ? Previous herpes vaccine; ? Pregnant, nursing and/or lactating females; ? Patients with herpetic stomatitis; ? Patients with severe symptoms or signs of herpes labialis such as intraoral lesions or lesions in the nostrils; - Subjects with lesions wider than 2.0cm2; - Subjects with renal, hepatic or metabolic dysfunction that may pose a risk to the safety;

Study & Design

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