Recurrent Herpes labialis
Conditions
Interventions
Trade Name: Pirocutan Gel
Product Name: HOV11 gel
Pharmaceutical Form: Gel
Pharmaceutical form of the placebo: Gel
Route of administration of the placebo: Topical use (Noncurrent)
Sponsors
HOV GmbH
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. females and males, at least 18 years of age, 2. written signed informed consent form, 3. at least 3 herpes labialis recurrencies during the past 12 months, but otherwise in good general health, 4. a history of prodromal symptoms during more than 50% of prior herpes labialis episodes (tingling, tenderness, pain, burning, itching, sensation of tension), 5. a history of more than 50% of the herpes labialis episodes producing classical lesions (i. e. vesicles, ulcers, and/or a hard crust) 6. recurrent herpes labialis in the prodromal or erythema stage reported at Visit 1 (day 0). 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 106 F.1.3 Elderly (>=65 years) no F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: 1. patients with alcohol or drug-abuse 2. pregnant or lactating women 3. women who plan to get pregnant during the time of the study 4. women of childbearing age who do not use a highly effective method of contraception (contraceptive measures with a Pearl index < 1 are considered highly effective) 5. known hypersensitivity to piroxicam, to any excipient of the study medication or to other analgesics or antirheumatics (non-steroidal anti-inflammatory drugs) 6. current participation in another study with an investigational drug or within 30 days Prior to the Screening Visit; 7. patients who receive any anti-viral medication; 8. patients with renal function impairments chronic obstructive pulmonary disease 9. patients with medical or psychiatric conditions which may pose a risk to the patient in this study or adversely interact with relevant study measures or the patient’s ability to participate in the study according to the investigator´s judgment 10. evidence of an uncooperative attitude or known or suspected inability to comply with the clinical study protocol 11. patients who are institutionalised due to a regulatory action or court order 12. if more than 12 hours have passed since the onset of the prodromal herpes labialis symptoms before Visit 1 (day 0)
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: The primary objective of this clinical study is to evaluate the efficacy of topically applied HOV11 gel versus placebo in the treatment of recurrent herpes labialis by assessment of the severity and duration of typical herpes labialis symptoms.;Secondary Objective: course of herpes labialis recurrency during and after the treatment Phase (course of herpes labialis single and cumulated prodromal symptoms over time; course of stronger symptoms over time: erythema, papule, vesicle, ulceration; course of herpes labialis stages over time; time to the occurrence and/ or end of specific symptoms of a herpes labialis recurrency); observation of the expansion of the herpes labialis affected area during and after the treatment Phase (course of the visible signs of the herpes labialis recurrency: length, width and severity of lesion); observation of additional symptoms (pain and swelling) over time by means of numerical rating scales; observation of the patient’s and investigator’s efficacy assessments during and after the treatment Phase (severity of the recurrency; improvement of the symptoms);Primary end point(s): Efficacy: • Maximum score describing the symptoms of an aggravating recurrency (as observed by the investigator in the CRF) The symptoms are (local language in brackets): 1 = prodromal symptoms (prodromale Symptome) 2 = erythema (Erythema) 3 = papule (Papeln) 4 = mild vesicle (leichte Vesikel) 5 = moderate vesicle (moderate Vesikel) 6 = severe vesicle (starke Vesikel) 7 = mild ulceration (leichte Ulzeration) 8 = moderate ulceration (moderate Ulzeration) 9 = severe ulceration (starke Ulzeration) • Time to maximum score describing the symptoms of an aggravating recurrency (measured from start of treatment) • Time to completely healed status measured from start of treatment (first application of study medication) to confirmed healing (by investigator’s diagnosis) ;Timepoint(s) of evaluation of this end point: Day 0, 1, 3, 6, 10, 14 by investigator; da | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): Efficacy: • Course of herpes labialis single and cumulated prodromal symptoms over time: - tingling - itching - burning - tenderness - sensation of tension • Course of stronger symptoms over time : - erythema - papules - vesicles - ulceration • Course of herpes labialis stages over time. The 8 stages and single symptoms are: stage 1 = prodromal phase (tingling, itching, burning, tenderness, sensation of tension) stage 2 = erythema phase stage 3 = papule phase stage 4 = vesicle phase stage 5 = ulceration phase stage 6 = crusting phase stage 7 = healing phase stage 8 = healed • Time to occurrence and/ or end of specific symptoms of the herpes labialis recurrency • Course of the visible signs of the herpes labialis recurrency: length, width and severity of lesion • Observation of additional symptoms (pain and swelling) over time by means of numerical rating scales (possible values of 0 to 10) • Patient’s and investigator’s assessment of the severity of the recurrency • Patient’s and investigator’s assessment of the improvement of symptoms;Timepoint(s) of evaluation of this end point: Day 0, 1, 3, 6, 10, 14 | — |
Countries
Germany
Contacts
Public ContactClinical Research Organisation
Mediconomics GmbH
Outcome results
None listed