Herpes Simplex Labialis MedDRA version: 9.1 Level: LLT Classification code 10019948 Term: Herpes simplex
Conditions
Interventions
Product Name: ACYCLOVIR 5% GEL LIQUIPATCH
Product Code: MI-LP-01 (Gel)
Pharmaceutical Form: Gel
INN or Proposed INN: Acyclovir
CAS Number: 59277-89-3
Other descriptive name: 2-amino-1,9-dihydro-9-(2-h
Sponsors
Mipharm SpA
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: - Both sexes, all ethnic backgrounds, outpatients, between 18 and 70 years of age, in good general health. - Subjects with a diagnosis of Herpes Simplex Labialis. The diagnosis is based on a clinical evaluation. - Ability to understand and comply with the prescriptions contained in the therapeutic protocol. - Subjects who have given their written informed consent in accordance with provisions of the pertinent excerpt of the Declaration of Helsinki. Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: - Subjects affected by diseases requiring the use of systemic or topical corticosteroids. - Concomitant use of other anti-herpetic/antiviral drugs - Concomitant use of anti-inflammatory medications or analgesics. - Concomitant use of any other drug administered as ointment, cream or gel, dermatological products, emollients, in the area of herpes labialis lesions. - Immunocompromised subjects. - Patients with herpetic stomatitis (first infection) - Patients with Herpes labialis severe symptoms or signs of more 24 hours in duration, intraoral lesions, or lesions within the nares. - Subjects with lesions wider than 2,0 cm2 - Traumatic loss of first crust - Subjects affected by severe renal, dismetabolic or hepatic failure which represent a risk to the subjects. - Presence of underlying medical conditions that might interfere with study completion. - Partecipation in any other study involving investigational or marketed products concomitantly or within one month prior to study entrance. - A history of alcoholism, drug abuse, psychological or other emotional problems that could invalidate informed consent or limit the subject compliance with protocol requirements. - breastfeeding females. - Necessity to have a concomitant therapy with any drug mentioned in the restrictions. - Subjects likely to be not compliant/uncooperative during the study, in the judgment of the clinical investigator.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To assess the efficacy, local tolerability and safety of a new topical formulation of acyclovir 5% gel (MILP-01), in comparison with acyclovir 5% cream for the treatment of subjects affected by Herpes Simplex Labialis.;Secondary Objective: not applicable;Primary end point(s): Primary endpoint is the evaluation of clinical efficacy from baseline, at visit day 3, visit day 4 and/or visit day 5, visit day 10. Trial efficacy primary endpoints will be: - the percentage of healed patients recorded within the 5th day of therapy; Secondary end points: 1. Evaluation of clinical efficacy by: Time to healing 2.Evaluation of clinical symptomatology by: Staging of lesions (vesicular, pustular, ulcerative, crusted, healed); Itching (absent, mild, moderate, severe) Total lesion area at day 3-4 and/or 5-10 3. Evaluation of local tolerability from baseline. The drug local tolerability will be evaluated on symptoms and feelings reported by subjects and objective data obtained by researchers during treatment. It will be performed by: A. Investigator's assessment of skin irritation. B. Other local reactions. C. Local Side Effects Global Assessment. D. Investigator's Global Assessment of local tolerability. | — |
Countries
Italy, United Kingdom
Outcome results
None listed