E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
Herpes labialis
Single-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; examinations on Days 0, 2, 3, 4, and 5; additional examinations on Day 8±1 and on Day 10 for patients still requiring therapy at the previous visit.
Primary efficacy:
Time in days until lesions are completely encrusted or epithelised
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E.1.1.1 | Medical condition in easily understood language |
Comparison of efficacy of the Medicinal care of Herpes Labialis using 2 cream with different substances. One cream with propolis special extract 0,5% and cream with aciclovir 5%.
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E.1.1.2 | Therapeutic area | Diseases [C] - Skin and Connective Tissue Diseases [C17] |
MedDRA Classification |
E.1.3 | Condition being studied is a rare disease | No |
E.2 Objective of the trial |
E.2.1 | Main objective of the trial |
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”)
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E.2.2 | Secondary objectives of the trial |
Pain
Itching/burning, tension/swelling
Investigator’s global efficacy evaluation
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E.2.3 | Trial contains a sub-study | No |
E.3 | Principal 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
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E.4 | Principal 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
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E.5 End points |
E.5.1 | Primary end point(s) |
Time in days until lesions are completely encrusted or epithelised |
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E.5.1.1 | 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”) |
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E.6 and E.7 Scope of the trial |
E.6 | Scope of the trial |
E.6.1 | Diagnosis | No |
E.6.2 | Prophylaxis | No |
E.6.3 | Therapy | Yes |
E.6.4 | Safety | Yes |
E.6.5 | Efficacy | Yes |
E.6.6 | Pharmacokinetic | No |
E.6.7 | Pharmacodynamic | No |
E.6.8 | Bioequivalence | No |
E.6.9 | Dose response | No |
E.6.10 | Pharmacogenetic | No |
E.6.11 | Pharmacogenomic | No |
E.6.12 | Pharmacoeconomic | No |
E.6.13 | Others | No |
E.7 | Trial type and phase |
E.7.1 | Human pharmacology (Phase I) | No |
E.7.1.1 | First administration to humans | No |
E.7.1.2 | Bioequivalence study | No |
E.7.1.3 | Other | No |
E.7.1.3.1 | Other trial type description | |
E.7.2 | Therapeutic exploratory (Phase II) | No |
E.7.3 | Therapeutic confirmatory (Phase III) | Yes |
E.7.4 | Therapeutic use (Phase IV) | No |
E.8 Design of the trial |
E.8.1 | Controlled | Yes |
E.8.1.1 | Randomised | Yes |
E.8.1.2 | Open | No |
E.8.1.3 | Single blind | Yes |
E.8.1.4 | Double blind | No |
E.8.1.5 | Parallel group | Yes |
E.8.1.6 | Cross over | No |
E.8.1.7 | Other | No |
E.8.1.7.1 | Other trial design description |
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E.8.2 | Comparator of controlled trial |
E.8.2.1 | Other medicinal product(s) | Yes |
E.8.2.2 | Placebo | No |
E.8.2.3 | Other | Yes |
E.8.2.3.1 | Comparator description |
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E.8.2.4 | Number of treatment arms in the trial | 2 |
E.8.3 |
The trial involves single site in the Member State concerned
| No |
E.8.4 | The trial involves multiple sites in the Member State concerned | Yes |
E.8.4.1 | Number of sites anticipated in Member State concerned | 4 |
E.8.5 | The trial involves multiple Member States | No |
E.8.6 Trial involving sites outside the EEA |
E.8.6.1 | Trial being conducted both within and outside the EEA | No |
E.8.6.2 | Trial being conducted completely outside of the EEA | No |
E.8.7 | Trial has a data monitoring committee | Yes |
E.8.8 |
Definition of the end of the trial and justification where it is not the last
visit of the last subject undergoing the trial
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E.8.9 Initial estimate of the duration of the trial |
E.8.9.1 | In the Member State concerned years | 3 |
E.8.9.1 | In the Member State concerned months | |
E.8.9.1 | In the Member State concerned days | |