Herpes labialis Double-blind, randomised, controlled parallel group comparison of a Propolis special extract GH 2002 cream (Herpetino® Balsam) and an aciclovir 5% containing cream. Up to 10 days treatment
Conditions
Interventions
Product Name: Propolis Cream 0,5%
Pharmaceutical Form: Cream
CAS Number: 8001003-42-7
Current Sponsor code: GH 2002
Concentration unit: % percent
Concentration type: equal
Concentration number: 0,5 %
Sponsors
HARRAS-PHARMA-CURARINA GmbH
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: Patients fulfilling the following criteria are eligible for participation in the study: 1. Patient is able to understand written and oral information on the study and has given written informed consent prior to participation in the study. 2. Male or female, Caucasian, between 18 and 70 years of age (both inclusive) 3. Confirmed clinical diagnosis of Herpes labialis WITH visible eruptions (erythematous or papular eruptions) for not more than 30 hours before the admission examination – NOT PRODROMAL ! 4. At least four herpes labialis episodes in the patient’s history 5. Prepared to comply with the study schedule regarding study medication use, non-use of concomitant medication, and visits 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 350 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 30
Exclusion criteria
Exclusion criteria: Patients who meet any of the following criteria are to be excluded from study participation. 1. Prodromal stage of Herpes labialis, i.e. burning or tension only 2. Vesicular, erosive, or encrusted stage of Herpes labialis 3. Known hypersensitivity or allergy to Propolis 4. Known hypersensitivity or allergy to Aciclovir 5. Concomitant viral infection, influenza, or flu-like symptoms 6. Evidence of congenital, acquired, or drug or malignancy induced immunodeficiency, including leukaemia or HIV infection 7. Severity or extent of Herpes labialis require systemic therapy 8. Local or systemic pre-treatment of this Herpes labialis episode (incl. prodromal symptoms) with zinc, corticosteroids, anti-viral medication, homeopathic drugs, or other possibly effective anti-herpes agents 9. Current or intended local or systemic use of anti-viral medication, of zinc in the area of the herpes infection, of homeopathic anti-herpes drugs, of other possibly effective anti-herpes agents, or of medication possibly influencing the immune system, e.g. corticosteroids, im munosuppressants, cytotoxic or cytostatic drugs, methotrexate 10. Previous or concurrent cancer 11. Drug, illicit substance, or alcohol abuse or other factors suggesting questionable compliance 12. Participation in another clinical trial within three months prior to this study 13. Previous participation in this trial 14. Involved in the performance of this trial
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: Time in days until lesions are completely encrusted or epithelised in 90% of patients in the respective study group (Study start to first day when all papules, vesicles, or erosions have vanished, i.e. there are only marks for “Crusted or with flakes” or “Completely epithelised”) ;Secondary Objective: Pain Itching/burning, tension/swelling Investigator’s global efficacy evaluation ;Primary end point(s): Time in days until lesions are completely encrusted or epithelised ;Timepoint(s) of evaluation of this end point: Time in days until lesions are completely encrusted or epithelised in 90% of patients in the respective study group (Study start to first day when all papules, vesicles, or erosions have vanished, i.e. there are only marks for “Crusted or with flakes” or “Completely epithelised”) | — |
Countries
Slovakia
Contacts
Public ContactHARRAS-PHARMA-CURARINA GmbH
HARRAS-PHARMA-CURARINA GmbH
Outcome results
None listed