Efficacy and tolerability of a new topical formulation of Acyclovir gel (Acyclorir Liquipatch) given 3 times/day in the treatment of herpes simplex labialis. An open-label, blind controlled, randomised, multicenter, controlled clinical trial versus active reference formulation (Acyclovir 5% cream) given 5 times/day. A superiority trial. - ND

• Conditions: Herpes Simplex Labialis on the perioral area; MedDRA version: 9.1Level: LLTClassification code 10019948Term: Herpes simplex

• Registration Number: EUCTR2008-005835-14-IT
• Lead Sponsor: MIPHARM

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2009-02-09
• Last Update Posted: 19 March 2012

Recruitment & Eligibility

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

Inclusion Criteria

1. Written informed consent obtained, 2. Patients of either sex aged > 18 and ≤ 70 years; 3. Patients in good general health conditions; 4. Patients with recurrent Herpes Simplex labialis infections; 5. Patients with clinically diagnosed Herpes Simplex labialis on the perioral area and burning symptoms started ≤ 24 hours; 6. Female subjects of childbearing potential (i.e., not status post hysterectomy or tubal ligation) must be using an appropriate method of contraception (implants, injectables, combined oral contraceptives, some IUDs, sexual abstinence or vasectomised partner) and must be willing to continue using it throughout the entire study period; 7. Female subjects of childbearing potential must have a negative urine pregnancy test at the baseline visit; 8. Patient?s co-operative attitude and able to understand and adhere to study protocol procedures and timelines.
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. Patients with diseases requiring systemic or topical corticosteroids; 2. Concomitant use of other anti-herpetic/antiviral drugs; 3. Concomitant use of anti-inflammatory medications or analgesics; 4. Concomitant use of any other drug administered as ointment, cream or gel, dermatological products, emollients, in the area of herpes labialis lesions; 5. Immunocompromised patients; 6. Patients with herpetic stomatitis (first infection); 7. Patients with Herpes labialis severe symptoms or signs of more 24 hours in duration, intraoral lesions, or lesions within the nares; 8. Patients with lesions wider than 2.0 cm2; 9. Traumatic loss of first crust; 10. Patients affected by severe renal, dysmetabolic or hepatic failure, which represent a risk to the subjects; 11. Presence of underlying medical conditions that might interfere with study completion; 12. Allergy, sensitivity or intolerance to study drug and/or study drug formulation ingredients; 13. History of alcoholism, drug abuse, psychological or other emotional problems that could invalidate informed consent or limit the subject compliance with protocol requirements; 14. Breastfeeding females; 15. Necessity to have a concomitant therapy with any drug mentioned in the restrictions. 16. Patients unlikely to comply with the protocol or unable to understand the nature, scope and possible consequences of the study; 17. Patients who received any investigational drug within the last 12 weeks; 18. Patients who have been previously enrolled in this study; 19. Employees of the investigator or study centre (i.e., principal investigator, sub-investigator, study coordinators, other study staff, employees, or contractors of each), with direct involvement in the proposed study or other studies under the direction of that investigator and/or study centre, as well as family members of the employees or the investigator.

Study & Design

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