Cold Sores caused by the herpes simplex virus (HSV) type 1. MedDRA version: 9.1 Level: LLT Classification code 10049352 Term: Cold sores lip
Conditions
Interventions
Trade Name: Vectavir Cold Sore Cream
Product Name: Penciclovir 1% Cream
Pharmaceutical Form: Cream
INN or Proposed INN: Penciclovir
Con
Sponsors
Novartis Consumer Health S.A.
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Be known to be a cold sore sufferer presenting a prodromal stage followed by classical lesions; 2. Have prodromal symptoms (tingling, burning) within 8 hours before randomisation. The presence of the cold sore has to be determined thermographically: An increase of at least 0.5°C in comparison with the controlateral side of the lips has to be observed. 3. Present pain due to a cold sore at baseline (intensity =30 mm on a Visual Analogue Scale (VAS) of 100 mm. 4. Sign the written informed consent form prior to enrolment in the trial; 5. Be aged 18 to 75 years; 6. If female of child-bearing potential, have a negative urine pregnancy test prior to inclusion; 7. Be a male or non-pregnant, non-lactating female. Women of child-bearing potential have to use acceptable methods of contraception which are surgical sterilisation (e.g., bilateral tubal ligation, vasectomy), hormonal contraception (implantable, patch, oral), double-barrier methods (any double combination of: IUD, male or female condom with spermicidal gel, diaphragm, sponge, cervical cap) and sterilised partners by vasectomy or other means. Total abstinence may be considered as acceptable at the discretion of the investigator in cases where the age, career, lifestyle, or sexual orientation of the subject ensures compliance. Periodic abstinence (e.g., calendar, ovulation, symptothermal,post-ovulation methods) and withdrawal are not acceptable methods of contraception. Reliable contraception should be maintained throughout the study. Women of non childbearing potential have to meet the following definition of post-menopausal status: 12 months of natural (spontaneous) amenorrhea or 6 months of spontaneous amenorrhea with serum FSH levels >40 mIU/m or 6 weeks post surgical bilateral oophorectomy with or without hysterectomy; 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. If female, are pregnant, planning pregnancy or lactating; 2. Have a known hypersensitivity to penciclovir or any ingredients of the vehicle; 3. Have already ongoing classical cold sore lesions at the baseline visit; 4. Have taken any cold sore product, analgesic or NSAID in the 24 hours before the baseline visit; 5. Have applied a cosmetic lip balm on their lips in the 12 hours before the baseline thermographic assessment; 6. Have a moustache or beard; 7. Are known to be immunosuppressed (acquired, congenital or therapeutic); 8. Have been involved in any investigational protocol within the 30 days prior to the trial; 9. Have evidence or history of drug or alcohol abuse; 10. Are a member or relative of the trial site staff or an employee of the trial site or Sponsor.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: The primary objective of the trial is to study whether early application of penciclovir 10 mg/g (1%) cream at the tingling or burning sensation stage associated with cold sores can prevent the development of blisters. The effectiveness of penciclovir 10 mg/g (1%) cream will be compared with that of cream vehicle (a cream which is identical in content, appearance, feel and smell but contains no active ingredient i.e. penciclovir) over a 4 day period. The effectiveness of the treatment given will be assessed using thermography which is an objective method for assessing the development of inflammation due to cold sores particularly during the stage when a participant can feel tingling and burning. ; Secondary Objective: The secondary objectives of the trial are to determine whether early application of Penciclovir cream among recurrent cold sore sufferers can: -prevent the development of Cold Sore blisters, which will be determined by clinical assessment -relieve pain associated with the Cold Sore -alter the size of the blisters if they do develop by thermography assessment -be considered safe by monitoring and recording Adverse Events. The study will also determine overall satisfaction with the Penciclovir cream by asking participants to complete a questionnaire. ;Primary end point(s): The primary endpoint is the thermographic assessment at 72 hours. The number and proportion of subjects who had negative thermographic assessments at 72 hours will be compared between the active and vehicle groups. | — |
Countries
United Kingdom
Outcome results
None listed