EUCTR2011-002135-26-ITActive, not recruitingNot Applicable
Efficacy and Safety of Acyclovir 5 Lipstick (Contra) in Treatment of Skin Infections Provoked by Herpes Simplex. A Randomised, Double-blind, Placebo Controlled, Parallel Group Study. - 4PH/2011/002
AESCULAPIUS FARMACEUTICI S.R.L.0 sitesStarted: December 27, 2011Last updated:
Drugs
Trial Snapshot
- Phase
- Not Applicable
- Status
- Active, not recruiting
- Sponsor
Study Overview
Brief Summary
No summary available.
Study Design
- Study Type
- Interventional clinical trial of medicinal product
Eligibility Criteria
- Sex
- All
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;
Investigators
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