A Study of the Clinical Activity of Monocaprin/Doxycycline Gel on Cold Sores

INTERVENTION: 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 number: 1.5‐ INN or Proposed INN: Monocaprinum INN CAS Number: 26402‐22‐2 Current Sponsor code: MC Concentration unit: mg/g milligram(s)/gram Concentration type: equal Concentration number: 5‐ Pharmaceutical form of the placebo: Gel Route of administration of the placebo: Topical use (Noncurrent) Pharmaceutical Form: Gel INN or Proposed INN: Monocaprinum INN CAS Number: 26402‐22‐2 Current Sponsor code: MC Concentration unit: mg/g milligram(s)/gram Concentration type: equal Concentration number: 5‐ CONDITION: 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. PRIMARY OUTCOME: 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. ; 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; Secondary Objective: 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