Recurrent herpes labialis (RHL)
Conditions
Interventions
Trade Name: Zovirax Cold Sore Cream
Product Name: Zovirax Cold Sore Cream
Pharmaceutical Form: Cream
INN or Proposed INN: Aciclovir
CAS
Sponsors
GlaxoSmithKline Consumer Healthcare
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1)Age 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. 4)Consent 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. 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) yes F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: 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. 3)Clinical Study/ Experimental Medication a.Participation in another clinical study or receipt of an investigational drug within 30 days of the screening visit. b.Previous participation in this study. 4)Abuse a.Recent history (within the last year) of alcohol or other substance abuse. 5)Pregnancy a.Females who are pregnant. b.Females of childbearing potential who are not practising an acceptable (in the opinion of the investigator) method of birth control. c.Females who are breast–feeding. 6)Allergy/Intolerance Known or suspected intolerance or hypersensitivity to the study materials (or closely related compounds) or any of their stated ingredients i.e. aciclovir, or any related anti-viral drug, or the cream base. 7)Personnel An employee of the sponsor or those individuals conducting the study at the study site.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To investigate the ability of 3 currently available medical device products to impact on the wound healing process of recurrent herpes labialis (RHL) such that the ‘scab’ is either reduced or modified in a way that improves healing and/or symptoms. ;Secondary Objective: To assess the safety of the study products, as assessed by the incidence and severity of adverse events (AEs).;Primary end point(s): One or more of the test products to show a clinically relevant improvement on the healing of the scab phase of RHL as determined by observational assessments of cold sore lesions (amount of scab and duration of hard crust) using clinician assessed methodologies. | — |
Countries
United Kingdom
Outcome results
None listed