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    Clinical Trial Results:
    Multi-centre, Randomized, Double-blind, Placebo-Controlled Pilot Safety and Efficacy Study of 8 Weeks of Treatment with DFD-07 for Actinic Keratosis of the Face and Scalp

    Summary
    EudraCT number
    		 2015-003804-21
    Trial protocol
    		 DE  
    Global end of trial date
    27 Sep 2016

    Results information
    Results version number
    		 v1(current)
    This version publication date
    24 Jun 2022
    First version publication date
    24 Jun 2022
    Other versions

    Trial information

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    Trial identification
    Sponsor protocol code
    DFD-07-CD-001
    Additional study identifiers
    ISRCTN number
    		 -
    US NCT number
    		 -
    WHO universal trial number (UTN)
    		 -
    Sponsors
    Sponsor organisation name
    Promius Pharma LLC
    Sponsor organisation address
    107 College Road East, Princeton, NJ, United States,
    Public contact
    Kent Allenby, Promius Pharma/Dr. Reddy’s Laboratories 107 College Road East Princeton, New Jersey, USA 08540, +1 609-375-9900,
    Scientific contact
    Flexopharm GmBH and Co. KG, Flexopharm GmBH and Co. KG, +1 609-375-9900, mail@flexopharm.com
    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
    03 Nov 2016
    Is this the analysis of the primary completion data?
    Yes
    Primary completion date
    25 Jul 2016
    Global end of trial reached?
    Yes
    Global end of trial date
    27 Sep 2016
    Was the trial ended prematurely?
    No
    General information about the trial
    Main objective of the trial
    The primary aim of the study was to investigate the efficacy of 1.25% DFD-07 after 8 weeks of self-application by the patient (1g of cream per day). The secondary aims of the study were to investigate efficacy and safety of 1.25% DFD-07 after 8 weeks of self-application by the patient and an additional follow-up period of 30 days.
    Protection of trial subjects
    The incidence of treatment emergent adverse events was summarized by severity and causality in relation to the study drug for both treatment groups. The following variables were calculated for each patient for the time windows from baseline to Week 2, from Week 2 to Week 4, from Week 4 to Week 8, and from baseline to EOT and summarized by time window, treatment, center, and overall: • Number of applications of study medication • Percentage of required number of applications performed • Amount (in grams) of study medication used • Percentage of required amount of study medication used • Mean study medication usage per application
    Background therapy
    		 -
    Evidence for comparator
    		 -
    Actual start date of recruitment
    02 Nov 2015
    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
    Germany: 111
    Worldwide total number of subjects
    111
    EEA total number of subjects
    111
    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)
    20
    From 65 to 84 years
    85
    85 years and over
    6

    Subject disposition

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    Recruitment
    Recruitment details
    		 -

    Pre-assignment
    Screening details
    		 Inclusion Criteria: 18 years of age and older, able to provide informed consent, skin type I, II or III according to Fitzpatrick etc. Exclusion Criteria: Significant history of alcohol or drug abuse, pregnancy, lactation etc.

    Period 1
    Period 1 title
    Overall Trial (overall period)
    Is this the baseline period?
    		 Yes
    Allocation method
    Randomised - controlled
    Blinding used
    		 Double blind
    Roles blinded
    		 Subject, Investigator

    Arms
    Are arms mutually exclusive
    Yes

    Arm title
    		 DFD-07
    Arm description
    		 Patients received treatment i.e., 1.25% DFD-07 cream (30 g tube), active ingredient being Celecoxib. The cream was topically applied to the selected area by the patient, maximum use of 1g per day.
    Arm type
    		 Experimental

    Investigational medicinal product name
    DFD-07 cream (1.25% celecoxib cream)
    Investigational medicinal product code
    DFD-07
    Other name
    Pharmaceutical forms
    Cream
    Routes of administration
    Topical
    Dosage and administration details
    Twice daily application to the selected areas by the patient with maximum total use per day of 1g.

    Arm title
    		 Placebo
    Arm description
    		 Placebo cream i.e., vehicle only (30g tube) was provided to the patients.
    Arm type
    		 Placebo

    Investigational medicinal product name
    Placebo Cream
    Investigational medicinal product code
    Placebo
    Other name
    Pharmaceutical forms
    Cream
    Routes of administration
    Topical
    Dosage and administration details
    Twice daily topical application to the selected area by the patient (maximum total use 1 g per day)

    Number of subjects in period 1
    		DFD-07 Placebo
    Started
    56
    55
    Completed
    50
    50
    Not completed
    6
    5
         Patient Violates Inclusion/Exclusion criteria
    1
    -
         Missing more than 20% of product applications
    -
    1
         Visit out of window
    1
    2
         Missing post baseline assessment
    4
    2

    Baseline characteristics

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    Baseline characteristics reporting groups
    Reporting group title
    Overall Trial
    Reporting group description
    		 -

    Reporting group values
    		 Overall Trial Total
    Number of subjects
    		 111 111
    Age categorical
    Units: Subjects
        In utero
    		 0 0
        Preterm newborn infants (gestational age < 37 wks)
    		 0 0
        Newborns (0-27 days)
    		 0 0
        Infants and toddlers (28 days-23 months)
    		 0 0
        Children (2-11 years)
    		 0 0
        Adolescents (12-17 years)
    		 0 0
        Adults (18-64 years)
    		 20 20
        From 65-84 years
    		 85 85
        85 years and over
    		 6 6
    Age continuous
    Units: years
        arithmetic mean (standard deviation)
    		 72.4 ( 8.15 ) -
    Gender categorical
    Units: Subjects
        Female
    		 9 9
        Male
    		 102 102

    End points

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    End points reporting groups
    Reporting group title
    DFD-07
    Reporting group description
    		 Patients received treatment i.e., 1.25% DFD-07 cream (30 g tube), active ingredient being Celecoxib. The cream was topically applied to the selected area by the patient, maximum use of 1g per day.

    Reporting group title
    Placebo
    Reporting group description
    		 Placebo cream i.e., vehicle only (30g tube) was provided to the patients.

    Primary: Percentage of Patients with complete clearance of all AK lesions at Week 8

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    End point title
    		 Percentage of Patients with complete clearance of all AK lesions at Week 8
    End point description
    End point type
    Primary
    End point timeframe
    Start of the trial till Week 8
    End point values
    		 DFD-07 Placebo
    Number of subjects analysed
    52
    51
    Units: percent
        number (not applicable)
    7.7
    7.8
    Statistical analysis title
    		 Chi-Squared Test
    Comparison groups
    DFD-07 v Placebo
    Number of subjects included in analysis
    103
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.9772
    Method
    		 Chi-squared
    Confidence interval

    Secondary: Percent of patients with complete clearance of AK lesions at the End of Study (EOS) Visit (8 weeks treatment plus 30-day follow up)

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    End point title
    		 Percent of patients with complete clearance of AK lesions at the End of Study (EOS) Visit (8 weeks treatment plus 30-day follow up)
    End point description
    End point type
    Secondary
    End point timeframe
    Start of the trial to End of Study (8 weeks+ 30 days follow up)
    End point values
    		 DFD-07 Placebo
    Number of subjects analysed
    50
    50
    Units: percent
        number (not applicable)
    20
    10
    Statistical analysis title
    		 Chi-Squared Test
    Comparison groups
    DFD-07 v Placebo
    Number of subjects included in analysis
    100
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.1614
    Method
    		 Chi-squared
    Confidence interval

    Secondary: Percentage of patients with complete clearance of AK lesions at Week 4

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    End point title
    		 Percentage of patients with complete clearance of AK lesions at Week 4
    End point description
    End point type
    Secondary
    End point timeframe
    Start of the trial till week 4
    End point values
    		 DFD-07 Placebo
    Number of subjects analysed
    53
    53
    Units: percent
        number (not applicable)
    1.9
    1.9
    Statistical analysis title
    		 Chi-Squared Test
    Comparison groups
    DFD-07 v Placebo
    Number of subjects included in analysis
    106
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 1
    Method
    		 Chi-squared
    Confidence interval

    Secondary: Percentage of patients with partial clearance of AK lesions at Weeks 4 and 8 and EOS Visit

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    End point title
    		 Percentage of patients with partial clearance of AK lesions at Weeks 4 and 8 and EOS Visit
    End point description
    End point type
    Secondary
    End point timeframe
    Partial clearance is defined as at least a 75% reduction in the number of AK lesions in the treatment area compared to Baseline. Analysis is performed at week 4, week 8 and end of study.
    End point values
    		 DFD-07 Placebo
    Number of subjects analysed
    50
    50
    Units: percent
        number (not applicable)
    36
    18
    Statistical analysis title
    		 Chi-Squared Test
    Comparison groups
    DFD-07 v Placebo
    Number of subjects included in analysis
    100
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.0426
    Method
    		 Chi-squared
    Confidence interval

    Adverse events

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    Adverse events information
    Timeframe for reporting adverse events
    Timeframe for reporting adverse event was at visit 2, visit 3, visit 4 (end of treatment) and visit 5 (end of study)
    Assessment type
    		 Systematic
    Dictionary used for adverse event reporting
    Dictionary name
    		 MedDRA
    Dictionary version
    19.0
    Reporting groups
    Reporting group title
    DFD-07
    Reporting group description
    		 -

    Reporting group title
    Placebo
    Reporting group description
    		 -

    Serious adverse events
    		 DFD-07 Placebo
    Total subjects affected by serious adverse events
         subjects affected / exposed
    0 / 56 (0.00%)
    0 / 55 (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: 5%
    Non-serious adverse events
    		 DFD-07 Placebo
    Total subjects affected by non serious adverse events
         subjects affected / exposed
    14 / 56 (25.00%)
    25 / 55 (45.45%)
    Neoplasms benign, malignant and unspecified (incl cysts and polyps)
    Bowen's disease
         subjects affected / exposed
    0 / 56 (0.00%)
    1 / 55 (1.82%)
         occurrences all number
    0
    1
    Lymphoma
         subjects affected / exposed
    0 / 56 (0.00%)
    1 / 55 (1.82%)
         occurrences all number
    0
    1
    Squamous cell carcinoma of head and neck
         subjects affected / exposed
    0 / 56 (0.00%)
    1 / 55 (1.82%)
         occurrences all number
    0
    1
    Viral acanthoma
         subjects affected / exposed
    0 / 56 (0.00%)
    1 / 55 (1.82%)
         occurrences all number
    0
    1
    Injury, poisoning and procedural complications
    Spinal compression fracture
         subjects affected / exposed
    1 / 56 (1.79%)
    0 / 55 (0.00%)
         occurrences all number
    1
    0
    Contusion
         subjects affected / exposed
    1 / 56 (1.79%)
    0 / 55 (0.00%)
         occurrences all number
    1
    0
    Skin abrasion
         subjects affected / exposed
    1 / 56 (1.79%)
    0 / 55 (0.00%)
         occurrences all number
    1
    0
    Cardiac disorders
    Cardiovascular disorder
         subjects affected / exposed
    0 / 56 (0.00%)
    1 / 55 (1.82%)
         occurrences all number
    0
    1
    Surgical and medical procedures
    Dermabrasion
         subjects affected / exposed
    0 / 56 (0.00%)
    1 / 55 (1.82%)
         occurrences all number
    0
    1
    Nervous system disorders
    Burning sensation
         subjects affected / exposed
    0 / 56 (0.00%)
    1 / 55 (1.82%)
         occurrences all number
    0
    1
    Headache
         subjects affected / exposed
    1 / 56 (1.79%)
    2 / 55 (3.64%)
         occurrences all number
    1
    2
    Ear and labyrinth disorders
    Tinnitus
         subjects affected / exposed
    1 / 56 (1.79%)
    0 / 55 (0.00%)
         occurrences all number
    1
    0
    Vertigo
         subjects affected / exposed
    1 / 56 (1.79%)
    2 / 55 (3.64%)
         occurrences all number
    1
    2
    Deafness unilateral
         subjects affected / exposed
    1 / 56 (1.79%)
    0 / 55 (0.00%)
         occurrences all number
    1
    0
    Hypoacusis
         subjects affected / exposed
    0 / 56 (0.00%)
    1 / 55 (1.82%)
         occurrences all number
    0
    1
    Eye disorders
    Cataract
         subjects affected / exposed
    0 / 56 (0.00%)
    1 / 55 (1.82%)
         occurrences all number
    0
    1
    Eye inflammation
         subjects affected / exposed
    1 / 56 (1.79%)
    0 / 55 (0.00%)
         occurrences all number
    1
    0
    Vision blurred
         subjects affected / exposed
    0 / 56 (0.00%)
    1 / 55 (1.82%)
         occurrences all number
    0
    1
    Skin and subcutaneous tissue disorders
    Alopecia
         subjects affected / exposed
    0 / 56 (0.00%)
    1 / 55 (1.82%)
         occurrences all number
    0
    1
    Dermatitis
         subjects affected / exposed
    0 / 56 (0.00%)
    1 / 55 (1.82%)
         occurrences all number
    0
    1
    Drug eruption
         subjects affected / exposed
    1 / 56 (1.79%)
    0 / 55 (0.00%)
         occurrences all number
    1
    0
    Eczema
         subjects affected / exposed
    1 / 56 (1.79%)
    2 / 55 (3.64%)
         occurrences all number
    1
    2
    Pain of skin
         subjects affected / exposed
    0 / 56 (0.00%)
    1 / 55 (1.82%)
         occurrences all number
    0
    1
    Pruritus
         subjects affected / exposed
    2 / 56 (3.57%)
    0 / 55 (0.00%)
         occurrences all number
    2
    0
    Rosacea
         subjects affected / exposed
    1 / 56 (1.79%)
    1 / 55 (1.82%)
         occurrences all number
    1
    1
    Skin lesion
         subjects affected / exposed
    1 / 56 (1.79%)
    0 / 55 (0.00%)
         occurrences all number
    1
    0
    Skin ulcer
         subjects affected / exposed
    0 / 56 (0.00%)
    1 / 55 (1.82%)
         occurrences all number
    0
    1
    Asteatosis
         subjects affected / exposed
    0 / 56 (0.00%)
    1 / 55 (1.82%)
         occurrences all number
    0
    1
    Skin mass
         subjects affected / exposed
    0 / 56 (0.00%)
    1 / 55 (1.82%)
         occurrences all number
    0
    1
    Musculoskeletal and connective tissue disorders
    Osteoarthritis
         subjects affected / exposed
    1 / 56 (1.79%)
    1 / 55 (1.82%)
         occurrences all number
    1
    1
    Synovial cyst
         subjects affected / exposed
    0 / 56 (0.00%)
    1 / 55 (1.82%)
         occurrences all number
    0
    1
    Infections and infestations
    Bronchitis
         subjects affected / exposed
    0 / 56 (0.00%)
    1 / 55 (1.82%)
         occurrences all number
    0
    1
    Erysipeloid
         subjects affected / exposed
    0 / 56 (0.00%)
    1 / 55 (1.82%)
         occurrences all number
    0
    1
    Flea infestation
         subjects affected / exposed
    1 / 56 (1.79%)
    0 / 55 (0.00%)
         occurrences all number
    1
    0
    Folliculitis
         subjects affected / exposed
    0 / 56 (0.00%)
    1 / 55 (1.82%)
         occurrences all number
    0
    1
    Herpes simplex
         subjects affected / exposed
    1 / 56 (1.79%)
    0 / 55 (0.00%)
         occurrences all number
    1
    0
    Nasopharyngitis
         subjects affected / exposed
    3 / 56 (5.36%)
    7 / 55 (12.73%)
         occurrences all number
    3
    7
    Gastrointestinal fungal infection
         subjects affected / exposed
    0 / 56 (0.00%)
    1 / 55 (1.82%)
         occurrences all number
    0
    1
    Oral herpes
         subjects affected / exposed
    1 / 56 (1.79%)
    0 / 55 (0.00%)
         occurrences all number
    1
    0
    Metabolism and nutrition disorders
    Gout
         subjects affected / exposed
    0 / 56 (0.00%)
    2 / 55 (3.64%)
         occurrences all number
    0
    2

    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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    The status and protocol content of GB trials is no longer updated since 1 January 2021. For the UK, as of 31 January 2021, EU Law applies only to the territory of Northern Ireland (NI) to the extent foreseen in the Protocol on Ireland/NI. Legal notice
    As of 31 January 2023, all EU/EEA initial clinical trial applications must be submitted through CTIS . Updated EudraCT trials information and information on PIP/Art 46 trials conducted exclusively in third countries continues to be submitted through EudraCT and published on this website.

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