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    Clinical Trial Results:
    Treatment of striae distensae with fractional radiofrequency and topical tretinoin: An intra-individual study with blinded outcome assessment

    Summary
    EudraCT number
    		 2021-003153-39
    Trial protocol
    		 DK  
    Global end of trial date
    05 Jul 2023

    Results information
    Results version number
    		 v1(current)
    This version publication date
    21 Jul 2024
    First version publication date
    21 Jul 2024
    Other versions

    Trial information

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    Trial identification
    Sponsor protocol code
    SDRFTT
    Additional study identifiers
    ISRCTN number
    		 -
    US NCT number
    		 NCT05461755
    WHO universal trial number (UTN)
    		 -
    Sponsors
    Sponsor organisation name
    Bispebjerg Hospital
    Sponsor organisation address
    Nielsine Nielsens Vej 17, Copenhagen NV, Denmark, 2400
    Public contact
    Merete Haedersdal, Bispebjerg Hospital, Department of Dermatology, 0045 24454393, merete.haedersdal@regionh.dk
    Scientific contact
    Gabriela Lladó Grove, Bispebjerg Hospital, Department of Dermatology, 0045 24454393, ggro0013@regionh.dk
    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
    05 Jul 2023
    Is this the analysis of the primary completion data?
    Yes
    Primary completion date
    05 Jul 2023
    Global end of trial reached?
    Yes
    Global end of trial date
    05 Jul 2023
    Was the trial ended prematurely?
    No
    General information about the trial
    Main objective of the trial
    The study aims to explore the potential of combination therapy with fractional radiofrequency and topical tretinoin for treatment and overall improvement of striae albae.
    Protection of trial subjects
    Safe, established interventions. Monthly clinical visits the first two months and a final visit at 20-weeks. Open contact to the treating clinician in case of questions during the entire trial.
    Background therapy
    		 No other therapies that the interventional treatments
    Evidence for comparator
    		 In the background literature in the field both fractional energy-based devices (such as radiofrequency) and topical tretinoin have been associated with skin remodeling for improvement of e.g. scars including striae
    Actual start date of recruitment
    22 Nov 2022
    Long term follow-up planned
    Yes
    Long term follow-up rationale
    		 Efficacy, Scientific research
    Long term follow-up duration
    		 3 Months
    Independent data monitoring committee (IDMC) involvement?
    No
    Population of trial subjects
    Number of subjects enrolled per country
    Country: Number of subjects enrolled
    Denmark: 20
    Worldwide total number of subjects
    20
    EEA total number of subjects
    20
    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
    0
    85 years and over
    0

    Subject disposition

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    Recruitment
    Recruitment details
    		 Recruitment was conducted in the clinical setting at Dept of Dermatology, Copenhagen University Hospital (Bispebjerg) including patients between 22.11.22 - 08.03.23

    Pre-assignment
    Screening details
    		 According to pre-defined inclusion and exclusion criteria

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

    Arms
    Are arms mutually exclusive
    No

    Arm title
    		 FRF+TT treatment
    Arm description
    		 Fractional Radiofrequency and Topical tretinoin
    Arm type
    		 Experimental

    Investigational medicinal product name
    Tretinoin
    Investigational medicinal product code
    Other name
    Retirides 0.1%
    Pharmaceutical forms
    Cream
    Routes of administration
    Topical
    Dosage and administration details
    tubes of 30 g, 1mg/g, topical application according to protocol

    Arm title
    		 TT treatment
    Arm description
    		 Topical tretinoin
    Arm type
    		 Active comparator

    Investigational medicinal product name
    Tretinoin
    Investigational medicinal product code
    Other name
    Retirides 0.1%
    Pharmaceutical forms
    Cream
    Routes of administration
    Topical
    Dosage and administration details
    tubes of 30 g, 1mg/g, topical application according to protocol

    Arm title
    		 FRF treatment
    Arm description
    		 Fractional radiofrequency
    Arm type
    		 Medical device

    Investigational medicinal product name
    No investigational medicinal product assigned in this arm
    Arm title
    		 Control
    Arm description
    		 Untreated control
    Arm type
    		 No intervention

    Investigational medicinal product name
    No investigational medicinal product assigned in this arm
    Number of subjects in period 1
    		FRF+TT treatment TT treatment FRF treatment Control
    Started
    20
    20
    20
    20
    Completed
    19
    19
    19
    19
    Not completed
    1
    1
    1
    1
         Lost to follow-up
    1
    1
    1
    1

    Baseline characteristics

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    Baseline characteristics reporting groups
    Reporting group title
    Overall trial
    Reporting group description
    		 20 patients at baseline, each receiving treatment with FRF+TT, TT, FRF and untreated control in four comparable areas (by randomization)

    Reporting group values
    		 Overall trial Total
    Number of subjects
    		 20 20
    Age categorical
    Units: Subjects
        In utero
    		 0
        Preterm newborn infants (gestational age < 37 wks)
    		 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)
    		 0
        From 65-84 years
    		 0
        85 years and over
    		 0
    Age continuous
    Age at baseline
    Units: years
        median (inter-quartile range (Q1-Q3))
    		 31 (28 to 37) -
    Gender categorical
    Units: Subjects
        Female
    		 19 19
        Male
    		 1 1
    Previous striae treatment
    previous interventional striae treatment
    Units: Subjects
        Yes
    		 1 1
        No
    		 19 19
    Body mass index
    BMI
    Units: kilogram(s)/square metre
        median (inter-quartile range (Q1-Q3))
    		 24.0 (21.2 to 26.4) -
    TT study usage
    Topical tretinoin study usage
    Units: gram(s)
        median (inter-quartile range (Q1-Q3))
    		 17.2 (13.5 to 22.9) -
    Treatment areas size
    Size of treatment areas
    Units: square centimetre
        median (inter-quartile range (Q1-Q3))
    		 46.5 (32 to 62) -

    End points

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    End points reporting groups
    Reporting group title
    FRF+TT treatment
    Reporting group description
    		 Fractional Radiofrequency and Topical tretinoin

    Reporting group title
    TT treatment
    Reporting group description
    		 Topical tretinoin

    Reporting group title
    FRF treatment
    Reporting group description
    		 Fractional radiofrequency

    Reporting group title
    Control
    Reporting group description
    		 Untreated control

    Primary: POSAS-PT SUM

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    End point title
    		 POSAS-PT SUM
    End point description
    End point type
    Primary
    End point timeframe
    Baseline compared to 20-week follow-up on patient POSAS sum
    End point values
    		 FRF+TT treatment TT treatment FRF treatment Control
    Number of subjects analysed
    19
    19
    19
    19
    Units: point
    median (inter-quartile range (Q1-Q3))
        Baseline
    25 (19 to 31)
    25 (20 to 33)
    24 (20 to 33)
    24 (20 to 30)
        Follow-up
    15 (10 to 22)
    19 (12 to 25)
    17 (13 to 24)
    19 (14 to 25)
    Statistical analysis title
    		 Delta baseline vs follow-up
    Statistical analysis description
    Baseline vs follow-up for each area
    Comparison groups
    FRF+TT treatment v TT treatment v FRF treatment v Control
    Number of subjects included in analysis
    76
    Analysis specification
    Pre-specified
    Analysis type
    		 equivalence [1]
    P-value
    		 < 0.05 [2]
    Method
    		 Wilcoxon (Mann-Whitney)
    Confidence interval
    Notes
    [1] - Baseline compared to 20-week follow-up
    [2] - Delta only significantly different between FRF+TT and control in favor of FRF+TT

    Secondary: POSAS-PT OVERALL

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    End point title
    		 POSAS-PT OVERALL
    End point description
    End point type
    Secondary
    End point timeframe
    Baseline compared to 20-week follow-up on patient POSAS overall
    End point values
    		 FRF+TT treatment TT treatment FRF treatment Control
    Number of subjects analysed
    19
    19
    19
    19
    Units: point
    median (inter-quartile range (Q1-Q3))
        Baseline
    7 (4 to 9)
    7 (5 to 8)
    7 (4 to 9)
    7 (5 to 8)
        Follow-up
    4 (3 to 6)
    5 (3 to 7)
    4 (3 to 6)
    5 (4 to 7)
    Statistical analysis title
    		 Delta baseline vs follow-up
    Comparison groups
    FRF+TT treatment v TT treatment v FRF treatment v Control
    Number of subjects included in analysis
    76
    Analysis specification
    Pre-specified
    Analysis type
    		 equivalence
    P-value
    		 < 0.005 [3]
    Method
    		 Wilcoxon (Mann-Whitney)
    Confidence interval
    Notes
    [3] - Delta only significantly different between FRF+TT and control in favor of FRF+TT

    Secondary: POSAS-OBS SUM

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    End point title
    		 POSAS-OBS SUM
    End point description
    End point type
    Secondary
    End point timeframe
    Baseline compared to 20-week follow-up on Observer POSAS sum
    End point values
    		 FRF+TT treatment TT treatment FRF treatment Control
    Number of subjects analysed
    19
    19
    19
    19
    Units: point
    median (inter-quartile range (Q1-Q3))
        Baseline
    12 (8 to 15)
    12 (9 to 14)
    12 (9 to 15)
    12 (8 to 14)
        Follow-up
    10 (9 to 14)
    11 (10 to 12)
    12 (10 to 15)
    11 (10 to 12)
    Statistical analysis title
    		 Delta baseline vs follow-up
    Comparison groups
    FRF+TT treatment v TT treatment v FRF treatment v Control
    Number of subjects included in analysis
    76
    Analysis specification
    Pre-specified
    Analysis type
    		 equivalence
    P-value
    		 > 0.05 [4]
    Method
    		 Wilcoxon (Mann-Whitney)
    Confidence interval
    Notes
    [4] - Delta non signficant in all areas

    Secondary: POSAS-OBS OVERALL

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    End point title
    		 POSAS-OBS OVERALL
    End point description
    End point type
    Secondary
    End point timeframe
    Baseline compared to 20-week follow-up on observer POSAS overall
    End point values
    		 FRF+TT treatment TT treatment FRF treatment Control
    Number of subjects analysed
    19
    19
    19
    19
    Units: point
    median (inter-quartile range (Q1-Q3))
        Baseline
    3 (2 to 4)
    3 (2 to 4)
    3 (2 to 4)
    3 (2 to 4)
        Follow-up
    2 (2 to 3)
    3 (2 to 3)
    2 (2 to 3)
    2 (2 to 3)
    Statistical analysis title
    		 Delta baseline vs follow-up
    Comparison groups
    FRF+TT treatment v TT treatment v FRF treatment v Control
    Number of subjects included in analysis
    76
    Analysis specification
    Pre-specified
    Analysis type
    		 equivalence
    P-value
    		 < 0.05 [5]
    Method
    		 Wilcoxon (Mann-Whitney)
    Confidence interval
    Notes
    [5] - Except for TT delta p=0.148. No statistical difference of deltas between arms

    Secondary: Safety - procedural pain

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    End point title
    		 Safety - procedural pain [6]
    End point description
    Procedural pain from isolated FRF by anatomic site on a numerical rating scale (0-10)
    End point type
    Secondary
    End point timeframe
    First treatment session
    Notes
    [6] - The end point is not reporting statistics for all the arms in the baseline period. It is expected all the baseline period arms will be reported on when providing values for an end point on the baseline period.
    Justification: Procedural pain only relevant for the isolated procedural treatment with FRF
    End point values
    		 FRF treatment
    Number of subjects analysed
    20
    Units: score
    median (full range (min-max))
        Abdomen
    3 (2 to 7)
        Nates
    2.5 (2 to 3)
        Inner thighs
    4 (4 to 8)
        Hips
    4 (4 to 4)
        Lower back
    5 (5 to 5)
        Knees
    6 (6 to 6)
    No statistical analyses for this end point

    Adverse events

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    Adverse events information [1]
    Timeframe for reporting adverse events
    Baseline until 20-week follow-up
    Adverse event reporting additional description
    According to GCP and the Danish Medicines Agency with yearly reports
    Assessment type
    		 Systematic
    Dictionary used for adverse event reporting
    Dictionary name
    		 None
    Dictionary version
    0
    Frequency threshold for reporting non-serious adverse events: 5%
    Notes
    [1] - There are no non-serious adverse events recorded for these results. It is expected that there will be at least one non-serious adverse event reported.
    Justification: No non-serious AE/AR above frequency threshold for reporting non-serious adverse events

    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.
    Quantitative assessment of striae apperance with images not possible due to image quality.
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