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    Clinical Trial Results:
    An open-label study to investigate the local tolerability and acceptability of Lipovir® Gel (Acyclovir 5%) compared to Zovirax® Cream (Acyclovir 5%) on patients with Recurrent Herpes Labialis

    Summary
    EudraCT number
    		 2017-000549-38
    Trial protocol
    		 PT  
    Global end of trial date
    09 Aug 2018

    Results information
    Results version number
    		 v1(current)
    This version publication date
    05 Aug 2021
    First version publication date
    05 Aug 2021
    Other versions
    Summary report(s)
    		 Synopsis

    Trial information

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    Trial identification
    Sponsor protocol code
    LIP-01-01
    Additional study identifiers
    ISRCTN number
    		 -
    US NCT number
    		 -
    WHO universal trial number (UTN)
    		 -
    Sponsors
    Sponsor organisation name
    Laboratorios Ojer Pharma, S.L.
    Sponsor organisation address
    Calle Sancho el Mayor Nº 2, 1º Izquierda, Pamplona, Spain, 31002
    Public contact
    Laboratorios Ojer Pharma, S.L., Laboratorios Ojer Pharma, S.L., +34 948 281 776, pojer@ojerpharma.com
    Scientific contact
    Blueclinical Lda, Blueclinical - Investigação e Desenvolvimento em Saúde, Lda, +351 220 995 159, regulatory@blueclinical.pt
    Paediatric regulatory details
    Is trial part of an agreed paediatric investigation plan (PIP)
    No
    Does article 45 of REGULATION (EC) No 1901/2006 apply to this trial?
    No
    Does article 46 of REGULATION (EC) No 1901/2006 apply to this trial?
    No
    Results analysis stage
    Analysis stage
    Final
    Date of interim/final analysis
    31 Oct 2018
    Is this the analysis of the primary completion data?
    No
    Global end of trial reached?
    Yes
    Global end of trial date
    09 Aug 2018
    Was the trial ended prematurely?
    No
    General information about the trial
    Main objective of the trial
    To evaluate the local tolerability and acceptability of Lipovir® Gel compared to Zovirax® Cream in patients with RHL, according to participants’ self-report.
    Protection of trial subjects
    This is a Phase IV study with products already approved, therefore there are no additional risks that required additional safety measures. Nevertheless, the safety of the participants was ensured during the whole study.
    Background therapy
    		 -
    Evidence for comparator
    		 -
    Actual start date of recruitment
    22 Feb 2018
    Long term follow-up planned
    No
    Independent data monitoring committee (IDMC) involvement?
    No
    Population of trial subjects
    Number of subjects enrolled per country
    Country: Number of subjects enrolled
    Portugal: 60
    Worldwide total number of subjects
    60
    EEA total number of subjects
    60
    Number of subjects enrolled per age group
    In utero
    0
    Preterm newborn - gestational age < 37 wk
    0
    Newborns (0-27 days)
    0
    Infants and toddlers (28 days-23 months)
    0
    Children (2-11 years)
    0
    Adolescents (12-17 years)
    0
    Adults (18-64 years)
    60
    From 65 to 84 years
    0
    85 years and over
    0

    Subject disposition

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    Recruitment
    Recruitment details
    		 The selection of participants for this trial will be made from the population of patients who go to the Institutions where the three sites are located.

    Pre-assignment
    Screening details
    		 Screening visit comprises medical history, physical examination, vital signs, 12-lead electrocardiogram and clinical laboratory safety tests. Screening results were valid for 28 days.

    Period 1
    Period 1 title
    Overall trial (overall period)
    Is this the baseline period?
    		 Yes
    Allocation method
    Randomised - controlled
    Blinding used
    		 Not blinded

    Arms
    Are arms mutually exclusive
    Yes

    Arm title
    		 Lipovir
    Arm description
    		 acyclovir 5% Gel
    Arm type
    		 Experimental

    Investigational medicinal product name
    Lipovir® gel
    Investigational medicinal product code
    Other name
    Lavirk®
    Pharmaceutical forms
    Gel
    Routes of administration
    Topical
    Dosage and administration details
    5 times daily (every 4 hours, avoiding sleep hours) up to a maximum of 10 days

    Arm title
    		 Zovirax
    Arm description
    		 acyclovir 5% Cream (comparator)
    Arm type
    		 Active comparator

    Investigational medicinal product name
    Zovirax® Cream
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Cream
    Routes of administration
    Topical
    Dosage and administration details
    5 times daily (every 4 hours, avoiding sleep hours) up to a maximum of 10 days

    Number of subjects in period 1
    		Lipovir Zovirax
    Started
    30
    30
    Completed
    30
    29
    Not completed
    0
    1
         Lost to follow-up
    -
    1

    Baseline characteristics

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    Baseline characteristics reporting groups
    Reporting group title
    Lipovir
    Reporting group description
    		 acyclovir 5% Gel

    Reporting group title
    Zovirax
    Reporting group description
    		 acyclovir 5% Cream (comparator)

    Reporting group values
    		 Lipovir Zovirax Total
    Number of subjects
    		 30 30 60
    Age categorical
    Units: Subjects
        Adults (18-64 years)
    		 30 30 60
    Gender categorical
    Units: Subjects
        Male
    		 8 9 17
        Female
    		 22 21 43
    Time since first symtomps
    Units: hours
        median (standard deviation)
    		 16.13 ± 10.14 18.48 ± 10.96 -

    End points

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    End points reporting groups
    Reporting group title
    Lipovir
    Reporting group description
    		 acyclovir 5% Gel

    Reporting group title
    Zovirax
    Reporting group description
    		 acyclovir 5% Cream (comparator)

    Primary: Bleeding (Products' local tolerability self-reported by the participant)

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    End point title
    		 Bleeding (Products' local tolerability self-reported by the participant)
    End point description
    Local tolerability was assessed at every treatment day by asking the subjects wether they experienced RHL lesions related symtomps
    End point type
    Primary
    End point timeframe
    From the first product administration (day 1) until the end of the study (Day 10)
    End point values
    		 Lipovir Zovirax
    Number of subjects analysed
    30
    29
    Units: Number of Symtoms
    28
    41
    Statistical analysis title
    		 Mann-Whitney Utests
    Comparison groups
    Lipovir v Zovirax
    Number of subjects included in analysis
    59
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.04166
    Method
    		 Wilcoxon (Mann-Whitney)
    Confidence interval

    Primary: Burning (Products' local tolerability self-reported by the participant)

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    End point title
    		 Burning (Products' local tolerability self-reported by the participant)
    End point description
    Local tolerability was assessed at every treatment day by asking the subjects wether they experienced RHL lesions related symptoms
    End point type
    Primary
    End point timeframe
    From the first product administration (day 1) until the end of the study (Day 10)
    End point values
    		 Lipovir Zovirax
    Number of subjects analysed
    30
    29
    Units: Number of Symptoms
    50
    87
    Statistical analysis title
    		 Effectiveness
    Comparison groups
    Lipovir v Zovirax
    Number of subjects included in analysis
    59
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.00009
    Method
    		 Wilcoxon (Mann-Whitney)
    Confidence interval

    Primary: Drying (Products' local tolerability self-reported by the participant)

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    End point title
    		 Drying (Products' local tolerability self-reported by the participant)
    End point description
    Local tolerability was assessed at every treatment day by asking the subjects wether they experienced RHL lesions related symptoms
    End point type
    Primary
    End point timeframe
    From the first product administration (day 1) until the end of the study (Day 10)
    End point values
    		 Lipovir Zovirax
    Number of subjects analysed
    30
    29
    Units: Number of Symptoms
    116
    151
    Statistical analysis title
    		 Effectiveness
    Comparison groups
    Lipovir v Zovirax
    Number of subjects included in analysis
    59
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.00009
    Method
    		 Wilcoxon (Mann-Whitney)
    Confidence interval

    Primary: Itching (Products' local tolerability self-reported by the participant)

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    End point title
    		 Itching (Products' local tolerability self-reported by the participant)
    End point description
    Local tolerability was assessed at every treatment day by asking the subjects wether they experienced RHL lesions related symptoms
    End point type
    Primary
    End point timeframe
    From the first product administration (day 1) until the end of the study (Day 10)
    End point values
    		 Lipovir Zovirax
    Number of subjects analysed
    30
    29
    Units: Number of Symptoms
    50
    84
    Statistical analysis title
    		 Effectiveness
    Comparison groups
    Lipovir v Zovirax
    Number of subjects included in analysis
    59
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.00016
    Method
    		 Wilcoxon (Mann-Whitney)
    Confidence interval

    Primary: Pain (Products' local tolerability self-reported by the participant)

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    End point title
    		 Pain (Products' local tolerability self-reported by the participant)
    End point description
    Local tolerability was assessed at every treatment day by asking the subjects wether they experienced RHL lesions related symptoms
    End point type
    Primary
    End point timeframe
    From the first product administration (day 1) until the end of the study (Day 10)
    End point values
    		 Lipovir Zovirax
    Number of subjects analysed
    30
    29
    Units: Number of Symptoms
    34
    43
    Statistical analysis title
    		 Effectiveness
    Comparison groups
    Lipovir v Zovirax
    Number of subjects included in analysis
    59
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.10012
    Method
    		 Wilcoxon (Mann-Whitney)
    Confidence interval

    Primary: Redness (Products' local tolerability self-reported by the participant)

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    End point title
    		 Redness (Products' local tolerability self-reported by the participant)
    End point description
    End point type
    Primary
    End point timeframe
    From the first product administration (day 1) until the end of the study (Day 10)
    End point values
    		 Lipovir Zovirax
    Number of subjects analysed
    30
    29
    Units: Number of Symptoms
    127
    148
    Statistical analysis title
    		 Effectiveness
    Comparison groups
    Lipovir v Zovirax
    Number of subjects included in analysis
    59
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.00371
    Method
    		 Wilcoxon (Mann-Whitney)
    Confidence interval

    Primary: Stinging (Products' local tolerability self-reported by the participant)

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    End point title
    		 Stinging (Products' local tolerability self-reported by the participant)
    End point description
    Local tolerability was assessed at every treatment day by asking the subjects wether they experienced RHL lesions related symptoms
    End point type
    Primary
    End point timeframe
    From the first product administration (day 1) until the end of the study (Day 10)
    End point values
    		 Lipovir Zovirax
    Number of subjects analysed
    30
    29
    Units: Number of Symptoms
    35
    46
    Statistical analysis title
    		 Effectiveness
    Comparison groups
    Lipovir v Zovirax
    Number of subjects included in analysis
    59
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.07185
    Method
    		 Wilcoxon (Mann-Whitney)
    Confidence interval

    Primary: Swelling (Products' local tolerability self-reported by the participant)

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    End point title
    		 Swelling (Products' local tolerability self-reported by the participant)
    End point description
    Local tolerability was assessed at every treatment day by asking the subjects wether they experienced RHL lesions related symptoms
    End point type
    Primary
    End point timeframe
    From the first product administration (day 1) until the end of the study (Day 10)
    End point values
    		 Lipovir Zovirax
    Number of subjects analysed
    30
    29
    Units: Number of Symptoms
    80
    100
    Statistical analysis title
    		 Effectiveness
    Comparison groups
    Lipovir v Zovirax
    Number of subjects included in analysis
    59
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.01546
    Method
    		 Wilcoxon (Mann-Whitney)
    Confidence interval

    Primary: Tingling (Products' local tolerability self-reported by the participant)

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    End point title
    		 Tingling (Products' local tolerability self-reported by the participant)
    End point description
    Local tolerability was assessed at every treatment day by asking the subjects wether they experienced RHL lesions related symptoms
    End point type
    Primary
    End point timeframe
    From the first product administration (day 1) until the end of the study (Day 10)
    End point values
    		 Lipovir Zovirax
    Number of subjects analysed
    30
    29
    Units: Number of Symptoms
    39
    58
    Statistical analysis title
    		 Effectiveness
    Comparison groups
    Lipovir v Zovirax
    Number of subjects included in analysis
    59
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.01597
    Method
    		 Wilcoxon (Mann-Whitney)
    Confidence interval

    Primary: Spread well on the skin (Product's Acceptability as assessed by the participant)

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    End point title
    		 Spread well on the skin (Product's Acceptability as assessed by the participant)
    End point description
    Subjects were asked to answer questions about the product's acceptability using a 4-point scale: Totally Agree, Agree, Disagree, Totally Disagree
    End point type
    Primary
    End point timeframe
    At the end of study
    End point values
    		 Lipovir Zovirax
    Number of subjects analysed
    30
    29
    Units: Number of Subjects
        Totally Agree
    28
    22
        Agree
    2
    7
        Disagree
    0
    0
        Totally Disagree
    0
    0
    Statistical analysis title
    		 Effectiveness
    Comparison groups
    Lipovir v Zovirax
    Number of subjects included in analysis
    59
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.03304
    Method
    		 Wilcoxon (Mann-Whitney)
    Confidence interval

    Primary: Pleasant texture (Product's Acceptability as assessed by the participant)

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    End point title
    		 Pleasant texture (Product's Acceptability as assessed by the participant)
    End point description
    Subjects were asked to answer questions about the product's acceptability using a 4-point scale: Totally Agree, Agree, Disagree, Totally Disagree
    End point type
    Primary
    End point timeframe
    At the end of study
    End point values
    		 Lipovir Zovirax
    Number of subjects analysed
    30
    29
    Units: Number of Subjects
        Totally Agree
    27
    17
        Agree
    3
    11
        Disagree
    0
    1
        Totally Disagree
    0
    0
    Statistical analysis title
    		 Effectiveness
    Comparison groups
    Lipovir v Zovirax
    Number of subjects included in analysis
    59
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.00292
    Method
    		 Wilcoxon (Mann-Whitney)
    Confidence interval

    Primary: Embarrassment social anxiety (Product's Acceptability as assessed by the participant)

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    End point title
    		 Embarrassment social anxiety (Product's Acceptability as assessed by the participant)
    End point description
    Subjects were asked to answer questions about the product's acceptability using a 4-point scale: Totally Agree, Agree, Disagree, Totally Disagree
    End point type
    Primary
    End point timeframe
    At the end of study
    End point values
    		 Lipovir Zovirax
    Number of subjects analysed
    30
    29
    Units: Number of Subjects
        Totally Agree
    1
    1
        Agree
    0
    2
        Disagree
    4
    11
        Totally Disagree
    25
    15
    Statistical analysis title
    		 Effectiveness
    Comparison groups
    Lipovir v Zovirax
    Number of subjects included in analysis
    59
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.00579
    Method
    		 Wilcoxon (Mann-Whitney)
    Confidence interval

    Primary: Non-compliance due to aesthetic reasons (Product's Acceptability as assessed by the participant)

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    End point title
    		 Non-compliance due to aesthetic reasons (Product's Acceptability as assessed by the participant)
    End point description
    Subjects were asked to answer questions about the product's acceptability using a 4-point scale: Totally Agree, Agree, Disagree, Totally Disagree
    End point type
    Primary
    End point timeframe
    At the end of study
    End point values
    		 Lipovir Zovirax
    Number of subjects analysed
    30
    29
    Units: Number of Subjects
        Totally Agree
    1
    0
        Agree
    1
    1
        Disagree
    6
    8
        Totally Disagree
    22
    20
    Statistical analysis title
    		 Effectiveness
    Comparison groups
    Lipovir v Zovirax
    Number of subjects included in analysis
    59
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.40164
    Method
    		 Wilcoxon (Mann-Whitney)
    Confidence interval

    Primary: Smaller herpes lesion (Product's Acceptability as assessed by the participant)

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    End point title
    		 Smaller herpes lesion (Product's Acceptability as assessed by the participant)
    End point description
    Subjects were asked to answer questions about the product's acceptability using a 4-point scale: Totally Agree, Agree, Disagree, Totally Disagree
    End point type
    Primary
    End point timeframe
    At the end of study
    End point values
    		 Lipovir Zovirax
    Number of subjects analysed
    30
    29
    Units: Number of Subjects
        Totally Agree
    9
    6
        Agree
    12
    12
        Disagree
    2
    4
        Totally Disagree
    7
    6
    Statistical analysis title
    		 Effectiveness
    Comparison groups
    Lipovir v Zovirax
    Number of subjects included in analysis
    59
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.29131
    Method
    		 Wilcoxon (Mann-Whitney)
    Confidence interval

    Primary: Faster healing (Product's Acceptability as assessed by the participant)

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    End point title
    		 Faster healing (Product's Acceptability as assessed by the participant)
    End point description
    Subjects were asked to answer questions about the product's acceptability using a 4-point scale: Totally Agree, Agree, Disagree, Totally Disagree
    End point type
    Primary
    End point timeframe
    At the end of study
    End point values
    		 Lipovir Zovirax
    Number of subjects analysed
    30
    29
    Units: Number of Subjects
        Totally Agree
    15
    6
        Agree
    9
    16
        Disagree
    3
    4
        Totally Disagree
    3
    3
    Statistical analysis title
    		 Effectiveness
    Comparison groups
    Lipovir v Zovirax
    Number of subjects included in analysis
    59
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.03875
    Method
    		 Wilcoxon (Mann-Whitney)
    Confidence interval

    Primary: Less Itching, burning and tingling (Product's Acceptability as assessed by the participant)

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    End point title
    		 Less Itching, burning and tingling (Product's Acceptability as assessed by the participant)
    End point description
    Subjects were asked to answer questions about the product's acceptability using a 4-point scale: Totally Agree, Agree, Disagree, Totally Disagree
    End point type
    Primary
    End point timeframe
    At the end of study
    End point values
    		 Lipovir Zovirax
    Number of subjects analysed
    30
    29
    Units: Number of Subjects
        Totally Agree
    17
    8
        Agree
    9
    11
        Disagree
    2
    8
        Totally Disagree
    2
    2
    Statistical analysis title
    		 Effectiveness
    Comparison groups
    Lipovir v Zovirax
    Number of subjects included in analysis
    59
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.01041
    Method
    		 Wilcoxon (Mann-Whitney)
    Confidence interval

    Primary: Comfort Sensation (Product's Acceptability as assessed by the participant)

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    End point title
    		 Comfort Sensation (Product's Acceptability as assessed by the participant)
    End point description
    Subjects were asked to answer questions about the product's acceptability using a 4-point scale: Totally Agree, Agree, Disagree, Totally Disagree
    End point type
    Primary
    End point timeframe
    At the end of study
    End point values
    		 Lipovir Zovirax
    Number of subjects analysed
    30
    29
    Units: Number of Subjects
        Totally Agree
    20
    5
        Agree
    9
    23
        Disagree
    1
    1
        Totally Disagree
    0
    0
    Statistical analysis title
    		 Effectiveness
    Comparison groups
    Lipovir v Zovirax
    Number of subjects included in analysis
    59
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.00016
    Method
    		 Wilcoxon (Mann-Whitney)
    Confidence interval

    Primary: Refreshing sensation (Product's Acceptability as assessed by the participant)

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    End point title
    		 Refreshing sensation (Product's Acceptability as assessed by the participant)
    End point description
    Subjects were asked to answer questions about the product's acceptability using a 4-point scale: Totally Agree, Agree, Disagree, Totally Disagree
    End point type
    Primary
    End point timeframe
    At the end of study
    End point values
    		 Lipovir Zovirax
    Number of subjects analysed
    30
    29
    Units: Number of Subjects
        Totally Agree
    18
    3
        Agree
    10
    13
        Disagree
    2
    12
        Totally Disagree
    0
    1
    Statistical analysis title
    		 Effectiveness
    Comparison groups
    Lipovir v Zovirax
    Number of subjects included in analysis
    59
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.00001
    Method
    		 Wilcoxon (Mann-Whitney)
    Confidence interval

    Primary: Skin around herpes lesion less dehydratated than usual (Product's Acceptability as assessed by the participant)

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    End point title
    		 Skin around herpes lesion less dehydratated than usual (Product's Acceptability as assessed by the participant)
    End point description
    Subjects were asked to answer questions about the product's acceptability using a 4-point scale: Totally Agree, Agree, Disagree, Totally Disagree
    End point type
    Primary
    End point timeframe
    At the end of study
    End point values
    		 Lipovir Zovirax
    Number of subjects analysed
    30
    29
    Units: Number of Subjects
        Totally Agree
    9
    4
        Agree
    14
    12
        Disagree
    3
    10
        Totally Disagree
    4
    3
    Statistical analysis title
    		 Effectiveness
    Comparison groups
    Lipovir v Zovirax
    Number of subjects included in analysis
    59
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.04827
    Method
    		 Wilcoxon (Mann-Whitney)
    Confidence interval

    Primary: Repairing effect (Product's Acceptability as assessed by the participant)

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    End point title
    		 Repairing effect (Product's Acceptability as assessed by the participant)
    End point description
    Subjects were asked to answer questions about the product's acceptability using a 4-point scale: Totally Agree, Agree, Disagree, Totally Disagree
    End point type
    Primary
    End point timeframe
    At the end of study
    End point values
    		 Lipovir Zovirax
    Number of subjects analysed
    30
    29
    Units: Number of Subjects
        Totally Agree
    9
    3
        Agree
    18
    20
        Disagree
    3
    6
        Totally Disagree
    0
    0
    Statistical analysis title
    		 Effectiveness
    Comparison groups
    Lipovir v Zovirax
    Number of subjects included in analysis
    59
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.02581
    Method
    		 Wilcoxon (Mann-Whitney)
    Confidence interval

    Primary: Good Tolerance (Product's Acceptability as assessed by the participant)

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    End point title
    		 Good Tolerance (Product's Acceptability as assessed by the participant)
    End point description
    Subjects were asked to answer questions about the product's acceptability using a 4-point scale: Totally Agree, Agree, Disagree, Totally Disagree
    End point type
    Primary
    End point timeframe
    At the end of study
    End point values
    		 Lipovir Zovirax
    Number of subjects analysed
    30
    29
    Units: Number of Subjects
        Totally Agree
    27
    18
        Agree
    3
    11
        Disagree
    0
    0
        Totally Disagree
    0
    0
    Statistical analysis title
    		 Effectiveness
    Comparison groups
    Lipovir v Zovirax
    Number of subjects included in analysis
    59
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.0064
    Method
    		 Wilcoxon (Mann-Whitney)
    Confidence interval

    Adverse events

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    Adverse events information
    Timeframe for reporting adverse events
    24-FEB-2018 to 09-AUG-2018
    Assessment type
    		 Systematic
    Dictionary used for adverse event reporting
    Dictionary name
    		 MedDRA
    Dictionary version
    21.0
    Reporting groups
    Reporting group title
    Lipovir
    Reporting group description
    		 -

    Reporting group title
    Zovirax
    Reporting group description
    		 -

    Serious adverse events
    		 Lipovir Zovirax
    Total subjects affected by serious adverse events
         subjects affected / exposed
    0 / 30 (0.00%)
    0 / 29 (0.00%)
         number of deaths (all causes)
    0
    0
         number of deaths resulting from adverse events
    0
    0
    Frequency threshold for reporting non-serious adverse events: 0%
    Non-serious adverse events
    		 Lipovir Zovirax
    Total subjects affected by non serious adverse events
         subjects affected / exposed
    0 / 30 (0.00%)
    1 / 29 (3.45%)
    General disorders and administration site conditions
    Application site dryness
         subjects affected / exposed
    0 / 30 (0.00%)
    1 / 29 (3.45%)
         occurrences all number
    0
    1

    More information

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    Substantial protocol amendments (globally)
    Were there any global substantial amendments to the protocol? No

    Interruptions (globally)
    Were there any global interruptions to the trial? No

    Limitations and caveats
    Limitations of the trial such as small numbers of subjects analysed or technical problems leading to unreliable data.
    None reported
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