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

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

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
EU CTR
Registry ID
EUCTR2011-002135-26-IT
Enrollment
Unknown
Registered
2011-12-27
Start date
2012-02-16
Completion date
Unknown
Last updated
2013-01-07

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

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: 14.1 Level: LLT Classification code 10019942 Term: Herpes labialis System Organ Class: 10021881 - Infections and infestations

Interventions

Trade Name: EFRIVIRALLABIALE*MAT CUT 3G 5% Pharmaceutical Form: Cutaneous stick INN or Proposed INN: NA CAS Number: 59277-89-3 Current Sponsor code: NA Other descriptive name: NA Concentration unit: g

Sponsors

AESCULAPIUS FARMACEUTICI S.R.L.
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

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

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;

Design outcomes

Primary

MeasureTime frame
Main Objective: evaluation of the efficacy of test formulation (Acyclovir 5% Lipstick from Aesculapius Farmaceutici Srl) in comparison with placebo;Secondary Objective: evaluation of the general safety of the active treatment (test formulation) in comparison with placebo.;Primary end point(s): evaluation of the efficacy of test formulation (Acyclovir 5 Lipstick from Aesculapius Farmaceutici Srl) in comparison with placebo;Timepoint(s) of evaluation of this end point: after the LVLP—

Secondary

MeasureTime frame
Secondary end point(s): evaluation of the general safety of the active treatment (test formulation) in comparison with placebo.;Timepoint(s) of evaluation of this end point: AFTER THE LVLP—

Countries

Italy

Contacts

Public Contactinformazione sulla sperimentazione

fourpharma srl

clinica@fourpharma.it+39.3474554772

Outcome results

None listed

Source: EU CTR (via WHO ICTRP) · Data processed: Feb 4, 2026