Herpes simplex virus (HSV) has plagued mankind worldwide for thousands of years. Once HSV enters the body, it penetrates vulnerable cells in the lower layers of human skin tissue and replicates itself in the cell nuclei. This process destroys host cells, thereby causing the blisters and inflammation characteristic of the infection. Incubation period is median 6-8 days with range 1-26 days. Recurrent infections are usually preceded by pain, burning, tingling and itching sensation.
Conditions
Interventions
Pharmaceutical Form: Gel
INN or Proposed INN: Doxycyclinum INN
CAS Number: 10592-13-9
Current Sponsor code: DOX
Concentration unit: mg/g milligram(s)/gram
Concentration type: equal
Concentration numbe
Sponsors
Bio-Gels Pharmaceuticals
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: Subject Inclusion Criteria To be eligible for participation in this study, all subjects • must have herpes labialis infection at prodromal or vesicle stage. • must be otherwise in good general health (without cardiac, hepatic, nephrological or allergic diseases) • must be between 18 and 65 years of age In addition, female volunteers • must not be pregnant at the time of enrollment • who will be sexually active during the course of the study must be using a method of birth control generally recognized as effective. 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) no F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: Subjects with any of the following conditions or characteristics will be excluded from study enrollment or discontinued participation: • Users of any antiviral products two weeks prior to the experiment. • Use of doxycycline two weeks prior to the experiment. • Do not have a history of recurrent herpes labialis infection as judged by the medical history. • Any use of other medications other than oral contraceptives. • Participating in another investigational study at the same time.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: The study objective is to investigate the effect of a hydrogel containing monocaprin and doxycycline or hydrogel containing monocaprin alone on herpes labialis infection compared to placebo, by evaluating the effect of treatment on the development of the disease during treatment. Time to healing. The size of lesion and assessment of pain, tenderness, edema and amount of crust will be analyzed. A sample swab for viral culture and/ or detection of HSV DNA by PCR will be made initially to confirm HSV presence in the soft tissue lesion. ;Secondary Objective: ;Primary end point(s): Primary endpoint • Clinical evaluation of efficacy by measuring the time from start of treatment to healing Secondary endpoints • Score for pain, tenderness, amount of crust and edema • Size of lesion • Acceptability of the study formulations | — |
Countries
Iceland
Outcome results
None listed