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

Phase 1

• Conditions: Recurrent herpes labialis (RHL)

• Registration Number: EUCTR2005-001384-60-GB
• Lead Sponsor: GlaxoSmithKline Consumer Healthcare

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2005-06-02
• Study Completion: 2005-11-29
• Last Update Posted: 25 November 2019

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: Not specified
• Target Recruitment: 36

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

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.

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
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.