EFFICACY AND SAFETY OF A NEW TOPICAL FORMULATION OF ACYCLOVIR GEL (LP) IN THE TREATMENT OF HERPES SIMPLEX LABIALIS

Mipharm SpA0 个研究点目标入组 180 人开始时间: 2007年6月14日最近更新: 2012年3月19日

试验速览

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•- Both sexes, all ethnic backgrounds, outpatients, between 18 and 70 years of age, in good general health.
•- Subjects with a diagnosis of Herpes Simplex Labialis. The diagnosis is based on a clinical evaluation.
•- Ability to understand and comply with the prescriptions contained in the therapeutic protocol.
•- Subjects who have given their written informed consent in accordance with provisions of the pertinent excerpt of the Declaration of Helsinki.
•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

•- Subjects affected by diseases requiring the use of systemic or topical corticosteroids.
•- Concomitant use of other anti-herpetic/antiviral drugs
•- Concomitant use of anti-inflammatory medications or analgesics.
•- Concomitant use of any other drug administered as ointment, cream or gel, dermatological products, emollients, in the area of herpes labialis lesions.
•- Immunocompromised subjects.
•- Patients with herpetic stomatitis (first infection)
•- Patients with Herpes labialis severe symptoms or signs of more 24 hours in duration, intraoral lesions, or lesions within the nares.
•- Subjects with lesions wider than 2,0 cm2
•- Traumatic loss of first crust
•- Subjects affected by severe renal, dismetabolic or hepatic failure which represent a risk to the subjects.
•- Presence of underlying medical conditions that might interfere with study completion.
•- Partecipation in any other study involving investigational or marketed products concomitantly or within one month prior to study entrance.
•- A history of alcoholism, drug abuse, psychological or other emotional problems that could invalidate informed consent or limit the subject compliance with protocol requirements.
•- breastfeeding females.
•- Necessity to have a concomitant therapy with any drug mentioned in the restrictions.
•- Subjects likely to be not compliant/uncooperative during the study, in the judgment of the clinical investigator.

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