Clinical Trial Results:
A Long-Term Safety and Efficacy Study of CD5789 50μg/g Cream in Subjects with Acne Vulgaris
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Summary
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EudraCT number |
2014-001755-23 |
Trial protocol |
HU CZ |
Global end of trial date |
23 Feb 2017
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Results information
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Results version number |
v1(current) |
This version publication date |
05 Apr 2019
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First version publication date |
05 Apr 2019
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Other versions |
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Summary report(s) |
Synopsis |
Trial Information
Subject Disposition
Baseline Characteristics
End Points
Adverse Events
More Information
Subject Disposition
Baseline Characteristics
End Points
Adverse Events
More Information
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Trial identification
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Sponsor protocol code |
RD.06.SPR.18250
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Additional study identifiers
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ISRCTN number |
- | ||
US NCT number |
NCT02189629 | ||
WHO universal trial number (UTN) |
- | ||
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Sponsors
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Sponsor organisation name |
Galderma S.A.
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Sponsor organisation address |
Avenue de Gratta-Paille 2, Lausanne, Switzerland, 1018
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Public contact |
CTA Coordinator, Galderma S.A., +41 21 642 78 00, cta.coordinator@galderma.com
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Scientific contact |
CTA Coordinator, Galderma S.A., +41 21 642 78 00, cta.coordinator@galderma.com
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Paediatric regulatory details
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Is trial part of an agreed paediatric investigation plan (PIP) |
Yes
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EMA paediatric investigation plan number(s) |
EMEA-001492-PIP01-13 | ||
Does article 45 of REGULATION (EC) No 1901/2006 apply to this trial? |
Yes
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Does article 46 of REGULATION (EC) No 1901/2006 apply to this trial? |
No
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Results analysis stage
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Analysis stage |
Final
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Date of interim/final analysis |
13 Apr 2017
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Is this the analysis of the primary completion data? |
Yes
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Primary completion date |
23 Feb 2017
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Global end of trial reached? |
Yes
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Global end of trial date |
23 Feb 2017
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Was the trial ended prematurely? |
No
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General information about the trial
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Main objective of the trial |
Open label study, non-comparative, to evaluate the safety of CD5789 50 microgram/g cream in subjects 9 years of age and older with moderate acne vulgaris on face and trunk. Efficacy was evaluated as a secondary endpoint.
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Protection of trial subjects |
All subjects were required to read and sign an informed consent. The subjects could withdraw from treatment at any time and for any reason.
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Background therapy |
Not applicable | ||
Evidence for comparator |
Not applicable | ||
Actual start date of recruitment |
23 Feb 2015
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Long term follow-up planned |
Yes
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Long term follow-up rationale |
Safety | ||
Long term follow-up duration |
12 Months | ||
Independent data monitoring committee (IDMC) involvement? |
No
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Population of trial subjects
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Number of subjects enrolled per country |
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Country: Number of subjects enrolled |
Czech Republic: 104
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Country: Number of subjects enrolled |
Germany: 95
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Country: Number of subjects enrolled |
Hungary: 91
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Country: Number of subjects enrolled |
United States: 163
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Worldwide total number of subjects |
453
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EEA total number of subjects |
290
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Number of subjects enrolled per age group |
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In utero |
0
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Preterm newborn - gestational age < 37 wk |
0
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Newborns (0-27 days) |
0
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Infants and toddlers (28 days-23 months) |
0
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Children (2-11 years) |
18
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Adolescents (12-17 years) |
268
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Adults (18-64 years) |
167
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From 65 to 84 years |
0
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85 years and over |
0
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Recruitment
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Recruitment details |
A total of 455 subjects were enrolled and 453 were exposed to CD5789 50 microgram/g cream for up to 52 weeks. A minimum of 14 days between Screening and Baseline visit ( +/- 3 days). Study visits for Weeks 1,2,4 and 8 (+/- 3 days). Study visits for Weeks 12,20,26,38, and 52 visits (+/- 5 days). | ||||||||||||||||||||||
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Pre-assignment
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Screening details |
Male or Female subjects, 9 years of age and older, with moderate acne vulgaris, at least 20 inflammatory lesions and 25 non-inflammatory lesions for the face, and , at least 20 inflammatory and 20 non-inflammatory lesion for the trunk. No more than 1 nodule on the face and trunk. Inclusion criteria for trunk was optional for subjects ages 9 to 11. | ||||||||||||||||||||||
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Period 1
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Period 1 title |
Overall Trial (overall period)
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Is this the baseline period? |
Yes | ||||||||||||||||||||||
Allocation method |
Non-randomised - controlled
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Blinding used |
Not blinded | ||||||||||||||||||||||
Blinding implementation details |
Open-label study
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Arms
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Arm title
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CD5789 50 microgram/gram | ||||||||||||||||||||||
Arm description |
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Arm type |
open label | ||||||||||||||||||||||
Investigational medicinal product name |
Trifarotene
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Investigational medicinal product code |
CD5789
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Other name |
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Pharmaceutical forms |
Cream
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Routes of administration |
Cutaneous use
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Dosage and administration details |
a thin layer of CD5789 50 microgram/gram cream (one pump actuation) was applied to the face and trunk. Apply daily, in the evening, for 12 weeks, after washing the treated area with a mild cleanser and allow to dry before applying drug. Use of moisturizer was encouraged.
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Baseline characteristics reporting groups
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Reporting group title |
Overall Trial
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Reporting group description |
- | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
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Subject analysis sets
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Subject analysis set title |
Safety Population
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Subject analysis set type |
Safety analysis | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Subject analysis set description |
Defined as all subjects who applied the study drug at least once.
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End points reporting groups
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Reporting group title |
CD5789 50 microgram/gram
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Reporting group description |
- | ||
Subject analysis set title |
Safety Population
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Subject analysis set type |
Safety analysis | ||
Subject analysis set description |
Defined as all subjects who applied the study drug at least once.
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End point title |
Safety and Local Tolerability Assessments [1] | |||
End point description |
Local Tolerability Worst Post Baseline (Face)
Local Tolerability Worst Post Baseline (Trunk)
Treatment Emergent Adverse Events
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End point type |
Primary
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End point timeframe |
Baseline to Week 52
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| Notes [1] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point. Justification: In this long-term safety study, all efficacy and safety data were analyzed descriptively. |
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Attachments |
Face Trunk |
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End point title |
Efficacy | |||||
End point description |
Success rate of IGA at each scheduled time point (face): subjects were considered a success at a particular visit if they had an IGA score of "Clear" (0) or "Almost clear" (1) at that visit and had a grade change of at least 2 from Baseline.Success rate of PGA at each scheduled time point (trunk): subjects were considered a success at a particular visit if they had a PGA score of "Clear" (0) or "Almost clear" (1) at that visit and had a grade change of at least 2 from Baseline.
For the summary statistics, the categorical variables were summarized by frequency and percentage. No inferential statistical analyses were performed.
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End point type |
Secondary
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End point timeframe |
Baseline to Week 52
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Adverse events information
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Timeframe for reporting adverse events |
Baseline to Week 52
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Adverse event reporting additional description |
Overall Summary of Treatment Emergent Adverse Events
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Assessment type |
Systematic | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
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Dictionary used for adverse event reporting
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Dictionary name |
MedDRA | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Dictionary version |
18.0
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Reporting groups
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Reporting group title |
CD5789 50 microgram/g cream
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Reporting group description |
Intent-to-Treat Subjects | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
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| Frequency threshold for reporting non-serious adverse events: 1% | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
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Substantial protocol amendments (globally) |
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| Were there any global substantial amendments to the protocol? Yes | |||
Date |
Amendment |
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07 Dec 2015 |
Definitions of treated areas:
The application of CD5789 50 microgram/g cream on the middle and/or lower back was allowed for safety assessment only, and the definition of SAFT population was redefined to account for this change (i.e., any subjects in the SAF population who also applied the study drug on the upper truncal region and/or on the middle and/or lower back at least once).
Safety: PK assessments:
In order to comply with specific recommendations regarding PK analysis obtained from FDA during the review of the clinical efficacy protocol via a special protocol assessment procedure (November 03, 2014; IND number 111091):
1.It was specified the minimum number of children (aged 9-11 years) to be enrolled for the 4-week PK assessment period (i.e., 16 evaluable subjects, with a minimum of 3 subjects/age).
2. To ensure to collect systemic exposure under maximal use conditions, it was specified that during the 4-week PK assessment period,subjects were to apply CD5789 50 microgram/g cream on the face and trunk, even if acne was not visibly present. At Week 4 visit, the study drug was to be applied by study staff at the study center on the same conditions. After the 4-week PK assessment period, subjects were to resume the treatment as indicated in the protocol on areas affected with acne vulgaris only.
3.Due to difficulties encountered in the recruitment of 9-11 year-old subjects for the PK assessment (systemic exposure under maximal use conditions), it was decided to perform a POE assessment at Week 52/ET visit. Only subjects who were not originally enrolled for the PK assessment were to be involved in this additional assessment. The procedure and rationale for the POE were detailed.
Other changes:
1. Japan was removed from the region(s)/countries involved in the study |
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Interruptions (globally) |
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| Were there any global interruptions to the trial? No | |||
Limitations and caveats |
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| Limitations of the trial such as small numbers of subjects analysed or technical problems leading to unreliable data. | |||
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