Herpes simplex labialis
Conditions
Interventions
Product Name: ME-609
Product Code: ME-609
Pharmaceutical Form: Cream
INN or Proposed INN: ACICLOVIR
CAS Number: 59277893
Concentration unit: % percent
Concentration type: equal
Concentration number: 5
Sponsors
Medivir AB
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Male or female, 12 - 17 years of age at inclusion 2. General good health, as judged by the Investigator. 3. History of recurrent herpes labialis with at least two recurrences during the last twelve months, as based on an interview with the subject 4. Agreement to refrain from - Using other topical medical, over-the-counter (OTC), or cosmetic products in or around the oral area during the herpes recurrence - Mechanical disruption of the area affected by herpes labialis during the study recurrence 5. Subjects must themselves, and where appropriate their legally acceptable representative (as required by IRB/IEC and local legal requirements), voluntarily sign and date the informed consent Are the trial subjects under 18? yes Number of subjects for this age range: F.1.2 Adults (18-64 years) no F.1.2.1 Number of subjects for this age range F.1.3 Elderly (>=65 years) no F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: 1. Treatment with other systemic or topical antiviral agents within two weeks prior to inclusion 2. Treatment with systemic corticosteroids, or with topical corticosteroids in or around the oral area, within two weeks prior to inclusion 3. Any evidence of an immunosuppressed state of the subject due to underlying disease (e.g. HIV infection) or concomitant treatment (e.g. cancer chemotherapy) 4. Significant skin conditions that occur in the area typically affected by herpes recurrences, and that would interfere with assessment of lesions such as atopic dermatitis, acne, eczema, psoriasis, or chronic vesiculobullous disorders 5. Receipt of an investigational drug or immunomodulatory agent within two weeks prior to inclusion, or concurrent participation in another research study 6. History of immediate hypersensitivity or serum sickness reaction to any nucleoside analogue antiviral agent, or to any topical steroid, or to the vehicle 7. Nursing or pregnancy
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: The objective of this study is to evaluate the safety of ME-609 for the treatment of herpes labialis recurrences in adolescents, 12 – 17 years of age. For evaluation of safety, the following variables will be assessed: • Adverse events • Categorization of recurrence • Maximum lesion area assessment ;Secondary Objective: None;Primary end point(s): • Adverse events • Categorization of recurrence • Maximum lesion area | — |
Countries
Sweden
Outcome results
None listed