A randomised, double-blind, vehicle controlled, single centre, parallel group, comparative study of the efficacy of penciclovir 10 mg/g (1%) cream in preventing the appearance of classical lesions in recurrent cold sore sufferers. - Penciclovir 1% Cream Efficacy Study
- Conditions
- Cold Sores caused by the herpes simplex virus (HSV) type 1.MedDRA version: 9.1 Level: LLT Classification code 10049352 Term: Cold sores lip
- Registration Number
- EUCTR2007-004316-31-GB
- Lead Sponsor
- ovartis Consumer Health S.A.
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- Not specified
- Target Recruitment
- 0
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
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.
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method