Study of a New Topical Natural Health Product for the Treatment of Herpes Labialis

Laboratoire Boreaderme

Status: Unknown

Conditions: Herpes Labialis

Treatments: Other: BOR15001L7; Other: Placebo

Study type: Interventional

Funder types: Industry

Identifiers

NCT02582086

15E-0601

Details and patient eligibility

About

The aim of this study is to determine the safety and efficacy of a topical natural health product in comparison to placebo for the treatment of herpes labialis.

Enrollment: 40 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

• Female and male, in good health, 18 years of age or older,
• With history of recurrent herpes labialis with at least twice a year during the past twenty-four months,
• Agreeing not to take another treatment against cold sore, nor anti-inflammatory, antibiotics and steroids,
• Cooperating in the study, able to be monitored at each visit, aware of the demands and duration of the controls, thus allowing perfect adherence to the established protocol,
• Must be willing and able to participate and to provide written informed consent,
• Female subjects of childbearing potential must have a negative pregnancy test at screening and agree to use a proper contraceptive method during the study.

Exclusion criteria

• Volunteers who refuse to introduce the product to be tested in its routine,
• With a history of hypersensitivity to the type of product to be tested (e.g., products that contain essential oil),
• Who have a history of eczema, topical dermatitis, psoriasis or significant skin anomalies on the areas to be tested,
• Who suffer from a serious illness or health problem or a critical or progressive disease,
• Who have taken prescription or over the counter medication that could affect skin characteristics or could bias the study (i.e. antibiotics, antihistamines, anti-inflammatories...) within 7 days prior to study beginning,
• Who have recently acquired or who currently have significant skin pigmentation, who frequent tanning salons or foresee exposure to the sun during the study,
• Who abuse alcohol, drugs and/or tobacco,
• Female subjects who are pregnant, breastfeeding or expecting to become pregnant during the study.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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40 participants in 2 patient groups, including a placebo group

BOR15001L7 Cream

Experimental group

Description:

BOR15001L7 Cream with 5% 15019L0

Treatment:

Other: BOR15001L7

Placebo Cream

Placebo Comparator group

Description:

Placebo Cream

Treatment:

Other: Placebo