Herpes simplex virus type 1 infection in the region of the mouth and the openings of the nose
Conditions
Interventions
Product Name: D2D001
Pharmaceutical Form: Gel
CAS Number: 7789-20-0
Other descriptive name: deuterium oxide
Concentration unit: % percent
Concentration type: equal
Concentration number: 97-
Pharmaceut
Sponsors
D2 Derma Europe Ltd.
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: ? Subjects aged = 18 years at the time of enrollment ? Previous history of recurrent herpes labialis (cold sore) at least 3 times a year. ? Women of child-bearing potential should have to use use a highly effective method of birth control, such as implants, injectables, combined oral contraceptives, sexual abstinence or vasectomised partner plus an additional mechanical measure (e.g. condom) by the partner ? Subjects who are willing and able to provide informed consent 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 ;Inclusion criteria: ? Subjects aged = 18 years at the time of enrollment ? Previous history of recurrent herpes labialis (cold sore) at least 3 times a year. ? Women of child-bearing potential should have to use use a highly effective method of birth control, such as implants, injectables, combined oral contraceptives, sexual abstinence or vasectomised partner plus an additional mechanical measure (e.g. condom) by the partner ? Subjects who are willing and able to provide informed consent 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
Exclusion criteria: ? Known allergy to Acyclovir or the investigational product ? Subjects undergoing systemic treatment with anti-viral drugs ? Subjects with a disease or therapy that may increase the risk of herpes infection such as malignant diseases or chemotherapy, immunosuppressive treatment or autoimmune diseases ? Pregnant or brestbreast-feeding women ? Participation in any other clinical trial within 4 weeks prior to enrollment or during this trial ;Exclusion criteria: ? Known allergy to Acyclovir or the investigational product ? Subjects undergoing systemic treatment with anti-viral drugs ? Subjects with a disease or therapy that may increase the risk of herpes infection such as malignant diseases or chemotherapy, immunosuppressive treatment or autoimmune diseases ? Pregnant or brestbreast-feeding women ? Participation in any other clinical trial within 4 weeks prior to enrollment or during this trial
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: The primary objective is the responder rate (RR) assessed by the physician`s global assessment (PGA). A subject is defined to be a responder, if PGA improved at least one point between visit 2 and visit 3. ;Secondary Objective: The secondary objectives are to evaluate the efficacy and safety as assessed by the physician`s and subject’s global assessment, the symptom sum scores of the diary, the assessment of lesion size, the time to heal, adverse events ( AEs), vital signs and physician’s assessment of tolerability;Primary end point(s): The primary endpoint of this study is the response rate at visit 3 (day7±1). A subject is defined to be a responder, if PGA improved at least one point between visit 2 and visit 3. In a first stage non-inferiority of D2D001 to Acyclovir will be evaluated by using PGA . In a second stage superiority of D2D001 to Placeboplacebo will be evaluated using the PGA. In a third stage superiority of D2D001 to Acyclovir will be evaluated using the PGA. ;Main Objective: The primary objective is the responder rate (RR) assessed by the physician`s global assessment (PGA). A subject is defined to be a responder, if PGA improved at least one point between visit 2 and visit 3. ;Secondary Objective: The secondary objectives are to evaluate the efficacy and safety as assessed by the physician`s and subject’s global assessment, the symptom sum scores of the diary, the assessment of lesion size, the time to heal, adverse events ( AEs), vital signs and physician’s assessment of tolerability;Primary end point(s): The primary endpoint of this study is the response rate at visit 3 (day7±1). A subject is defined to be a responder, if PGA improved at least one point between visit 2 and visit 3. In a first stage non-inferiority of D2D001 to Acyclovir will be evaluated by using PGA . In a second stage superiority of D2D001 to Placeboplacebo will be evaluated using the PGA. In a third stage superiority of D2D001 to Acyclovir will be evaluated us | — |
Countries
Germany
Contacts
Public Contact; ;
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Outcome results
None listed