BOR15001L7 is a natural product. The primary objective of this study is to demonstrate its non-inferiority to docosanol 10% based on the healing time of cold sores in patients with recurrent herpes labialis.
Secondary objectives are to: 1. Evaluate the efficacy of BOR1500L7 on: * The reduction of ulcerative lesions rates following the prodromal stage; * The extension of the delay prior to first ulcerative lesions occurence following the prodromal stage; * The decrease of cumulative ulcerative lesions dimensions during papule, vesicles, ulcers/soft and hard crust stages; * The decrease of symptoms intensity (pain, tingling, itching, burning sensation) during prodromal, erythema, papule, vesicles, ulcers/soft crust, hard crust, re-epithelialize stages; * The reduction of symptoms duration (pain, tingling, itching, burning sensation) during the prodromal, erythema, papule, vesicles, ulcers/soft crust, hard crust, re-epithelialize stages in subjects with recurrent herpes labialis; 2. Evaluate the safety and tolerability of BOR15001L7 in subjects with recurrent herpes labialis
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
164
BOR15001L7 topically applied to infected area, 5 times a day, until complete healing of the infection.
Comparator product topically applied to infected area, 5 times a day, until complete healing of the infection.
The mean change of healing time
Time frame: Day 1 to 12
The change in lesion rates following the prodromal stage
Time frame: Day 1 to 12
The mean change in delays (hours) between the prodromal stage and the first visible occurence of lesions
Time frame: Day 1 to 12
The percentage change in number of lesions at papule, vesicles and ulcers/soft crust, hard crust stages
Time frame: Day 1 to 12
The percentage change in dimensions (mm) of lesions at papule, vesicles and ulcers/soft crust, hard crust stages
Time frame: Day 1 to 12
The percentage of patients that demonstrated a change in intensity of drug-related symptoms (pain, tingling, itching, burning sensation) at papule, vesicles and ulcers/soft crust, hard crust stages
Time frame: Day 1 to 12
The mean change in duration (hours) of drug-related symptoms (pain, tingling, itching, burning sensation) at papule, vesicles and ulcers/soft crust, hard crust stages
Time frame: Day 1 to 12
Safety and tolerability measured by the Incidence of Treatment-Emergent Adverse Events [Side-effects]
Time frame: Day 1 to 12
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