Comparative Study of two creams (Propolis and Aciclovir) with different efficacy substances in Herpes labialis treatment

Recruitment & Eligibility

Status: ot Recruiting

Sex: All

Target Recruitment: Not specified

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

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

Study & Design

Study Type: Interventional clinical trial of medicinal product

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Main Objective: Time in days until lesions are completely encrusted or epithelised in<br>90% of patients in the respective study group (Study start to first day<br>when all papules, vesicles, or erosions have vanished, i.e. there are<br>only marks for Crusted or with flakes” or Completely epithelised”)<br>;Secondary Objective: Pain<br>Itching/burning, tension/swelling<br>Investigator’s global efficacy evaluation<br>;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”)

Secondary Outcome Measures

Name	Time	Method

Related Trials