An exploratory, observational cohort study investigating commercially available treatments which may reduce the scab stage of recurrent herpes labialis

GlaxoSmithKline Consumer Healthcare0 sites36 target enrollmentJune 2, 2005

Overview

No summary available.

Registry

who.int

Start Date

June 2, 2005

End Date

November 29, 2005

Last Updated

6 years ago

Study Type

Interventional clinical trial of medicinal product

Sponsor

GlaxoSmithKline Consumer Healthcare

•Aged at least 18 years of age.
•2\)Cold Sore History
•a.History of recurrent herpes labialis and with at least three recurrences during the 12 months prior to screening visit.
•b.Must have started treating this cold sore episode with topical Zovirax cream at first signs or symptoms of the lesion.
•c.Only subjects who have reached the papular/oedematous (stage 2\) of their cold sore will be included
•3\)Compliance
•Understands and is willing, able and likely to comply with all study procedures and restrictions.
•Demonstrates understanding of the study and willingness to participate as evidenced by voluntary written informed consent and has received a signed and dated copy of the informed consent form.
•5\)General Health
•Good general health with (in the opinion of the investigator) no clinically significant and relevant abnormalities of medical history.

•1\)Medical History
•a.Any evidence of active malignancy, immunodeficient disease, or use of immuno\-modifying drugs (e.g. systemic steroids) within 30 days prior to Screening Visit.
•b.Subject has abnormal skin conditions that occur in the area ordinarily affected by cold sores which might affect the normal course of cold sores (e.g. eczema, psoriasis, albinism or chronic vesiculobullous disorders).
•c.Subject has a recent history of renal dysfunction or serious hepatic disease.
•d.Current or previous medical history which may require treatment or make the subject unlikely to finish the study.
•e.Subjects for whom Zovirax is contra\-indicated.
•f.Subjects presenting with a non\-classical cold sore lesion or a significant history of cold sores which abort.
•2\)Prior/ Concomitant Medication
•a.Subject requires chronic use of analgesics, pain medication or non\-steroidal anti\-inflammatory agents (NSAIDs).
•b.Subjects using topical steroids on or near the face within 30 days of Screening Visit.