Safety of a Novel Patch to treat Herpes Labialis V3.0
Research type
Research Study
Full title
A Two-Arm, Randomized, Double-Blind Study to Examine the Safety of a Novel Patch Containing Acyclovir Versus COMPEED Invisible Patch for the Treatment of Herpes Labialis under Actual-Use Conditions
IRAS ID
136731
Contact name
Rashid Haye
Contact email
Sponsor organisation
Johnson & Johnson Consumer and Personal Products Worldwide
Research summary
Herpes Simplex Labialis (HSL) or cold sores are a common recurring infection of the lips or skin surrounding the lips caused by herpes simplex virus (HSV). An effective topical treatment option for cold sores has been wound management using dressings (cold sore patches) which promote the best environment for healing.
The sponsor, Johnson & Johnson, has developed a new variant on its Cold Sore Patches. The novel patch contains 5% acyclovir (ACV) to treat the cold sore. It is designed to promote healing and relieve cold sore symptoms. ACV is a widely used over the counter topical drug used for the treatment of cold sores.
This study aims to evaluate the safety of the newly developed patch for the treatment of HSL.
This study will be conducted at Intertek CRS over a 3 month period and will be run in the UK. The study aims to recruit approximately 300 suitable subjects where half of the population will be given the novel patch and the other half given an existing marketed cold sore patch (Compeed Invisible Patch).
When the subject feels a cold sore developing they will start to use the treatment within 1 hour and return to the site within 24hours. The subject will then return after 4-5 days of treatment and then at 10 days or earlier if the cold sore has healed before then.
During these visits, the subjects will undergo self assessments and assessments by a trained clinician. The subjects will also evaluate cold sore condition daily via a subject diary.The aim is for approximately 100 subjects (50 subjects per patch) to experience a cold sore outbreak and complete assessments. Once this is reached, the study will end and remaining subjects will be informed not to treat with the investigational product.
REC name
North East - York Research Ethics Committee
REC reference
13/NE/0288
Date of REC Opinion
5 Nov 2013
REC opinion
Further Information Favourable Opinion