Acne VulgarisPhase 4NCT03883269
Anti-inflammatory Effects of Topical Erythromycin and Clindamycin in Acne Patients
A Phase 4 study testing Erythromycin 4% topical gel formulation, Clindamycin 1% topical lotion formulation and 70% topical ethanol solution in people with Acne Vulgaris, run by Centre for Human Drug Research, Netherlands at 1 site in Netherlands.
Trial summary
The combined bacteriostatic and immunomodulatory effects of erythromycin and clindamycin will be explored. Treatment effects will be extensively characterized by conventional methods including lesion counts, global assessment scales and visual grading as well as state-of-the-art methodology, including multi-modal… Read more about this study
- Who is it for?
- Ages 18 to 45 yearsHealthy volunteers can take part
- Conditions the study is for
- Acne Vulgaris
- What is being tested?
- Erythromycin 4% topical gel formulation, Clindamycin 1% topical lotion formulation and 70% topical ethanol solution
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 30 participants
- Where
- 1 siteNetherlands
- Study dates
- 20 Mar 2018to Dec 2019
- Phase
- Phase 4
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 45 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Healthy male and female subjects, 18 to 45 years of age. The health status is verified by absence of evidence of any clinical significant active or uncontrolled chronic disease other than AV following a detailed medical history, a complete physical examination including vital signs, 12-lead ECG, hematology, blood chemistry, virology and urinalysis;
- Mild to moderate inflammatory acne vulgaris on the face, ≥5 inflammatory lesions (papules and/or pustules), present at screening and baseline visit
- A maximum of 5 nodules present at screening and baseline visit
- Inflammatory acne present for at least 6 months
- Fitzpatrick skin type I-II (Caucasian)
- Able and willing to give written informed consent and to comply with the study restrictions.
- Willing to comply with 2x2mm facial skin punch biopsies
Who cannot join
- Severe acne where systemic treatment is needed
- Use of any topical (anti-acne) medication (prescription or OTC) within 2 weeks prior to baseline
- Use of any oral/systemic treatment for acne, including oral antibiotics, excluding OAC, within 4 weeks prior to baseline
- Use of systemic isotretinoin within 6 months prior to baseline
- History of pathological scar formation (keloid, hypertrophic scar)
- Known hypersensitivity to erythromycin or clindamycin, drugs of the same class, or any of their excipients.
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- Known contact dermatitis reaction to any product
- Tanning due to sunbathing, excessive sun exposure or a tanning booth within 3 weeks of enrollment.
- Participation in an investigational drug or device study within 3 months prior to screening or more than 4 times a year.
- Loss or donation of blood over 500 mL within three months (males) or four months (females) prior to screening
- Pregnant, a positive pregnancy test, intending to become pregnant, or breastfeeding
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Netherlands1 site, 1 recruiting
- Recruiting
Centre for Human Drug Research
Leiden, 2333 CL
Robert Rissmann, PharmD, PhD, +31 71 5246 400, clintrials@chdr.nl
Diana Noort, +31 71 5246 400, clintrials@chdr.nl
About this study
Official title: A Randomized, Placebo-controlled, Evaluator-blinded, Study to Assess the Anti-inflammatory Effects of Topical Erythromycin and Clindamycin in Patients With Inflammatory Facial Acne
The combined bacteriostatic and immunomodulatory effects of erythromycin and clindamycin will be explored. Treatment effects will be extensively characterized by conventional methods including lesion counts, global assessment scales and visual grading as well as state-of-the-art methodology, including multi-modal photo analysis, perfusion by laser speckle contrast imaging, analysis of local skin surface, biopsy biomarkers and skin microbiota. This extensive response profiling, combined with the mechanistic insights from concurrent in vitro and in vivo studies in healthy volunteer challenges, will increase the understanding of erythromycin's and clindamycin's effects in acne vulgaris.
- Conditions
- Acne Vulgaris
- Being tested
- Erythromycin 4% topical gel formulation, Clindamycin 1% topical lotion formulation, 70% topical ethanol solution
- Medical subject headings
- Acne Vulgaris
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Erythromycin 4% topical gel formulationDrug
Erythromycin 4% topical gel formulation, BID, 4 weeks
Clindamycin 1% topical lotion formulationDrug
Clindamycin 1% topical lotion formulation, BID, 4 weeks
70% topical ethanol solutionDrug
70% topical ethanol solution, BID, 4 weeks
| Study group | Role | What they receive |
|---|---|---|
| Erythromycin 4% | Experimental | Erythromycin 4% topical gel formulation, BID, 4 weeks Receives: Drug: Erythromycin 4% topical gel formulation |
| Clindamycin 1% | Experimental | Clindamycin 1% topical lotion formulation, BID, 4 weeks Receives: Drug: Clindamycin 1% topical lotion formulation |
| ethanol solution | Placebo comparator | 70% topical ethanol solution, BID, 4 weeks Receives: Drug: 70% topical ethanol solution |
What is being measured
The primary outcome is the main question the study is designed to answer.
Efficacy endpoint 1 - Change in lesion count
The inflammatory lesions include papules pustules and nodules/cysts. At screening and every study visit, the evaluator will count the inflammatory lesions separately by area on the face (forehead, right cheek, left cheek, chin and nose). All lesion counts during the treatment and follow-up period will be performed by a treatment-blinded evaluator
Measured: Day 0, day 7, day 14, day 21, day 28 and day 42
Efficacy endpoint 2 - Change in investigator Global Assessment acne (IGA)
Acne severity will be assessed at screening and every study visit by the Investigator Global Assessment for facial acne (clear, almost clear, mild, moderate, severe, very severe). This will be done by a treatment blinded evaluator.
Measured: Day 0, day 7, day 14, day 21, day 28 and day 42
Change in Patient Reported Outcome (PRO)
Pre-dose and at EOT patients will be asked how they would rate their acne that day using the subjective Patient Global Assessment (clear, almost clear, mild, moderate, severe, very severe)
Measured: Day 0 and day 28
Pharmacodynamic endpoints 1 - Change in Standardized facial photography by Canfield Visia and via selfie app
A standardized set of 3 facial photos (front, left, right) will be taken every study visit by Canfield Visia CR. Furthermore, patients will take daily selfies with a validated mobile app.
Measured: Day 0, day 7, day 14, day 21, day 28 and day 42
Pharmacodynamic endpoints 2 - Change in Sebum measurements by Sebumeter®
Sebum excretion will be measured every study visit by Sebumeter®. The measurement will be repeated for 3 times and the average will be used for the analysis.
Measured: Day 0, day 7, day 14, day 21, day 28 and day 42
Pharmacodynamic endpoints 3 - Change in Perfusion by Laser Speckle Contrast Imaging (LSCI)
Cutaneous microcirculation will be assessed using the laser speckle imager (LSCI; PeriCam PSI System, Perimed Jäfälla, Sweden). Measurements have to be performed in a temperature controlled room with a temperature around 22°C. The subject has to get accommodated to the room temperature for a minimum of 15 minutes prior to testing. After this, the speckle assessments can commence. Briefly, the subject will be resting for at least ten minutes before any measurements take place. A suitable area of the face will be identified. This area will be illuminated' by the laser and the response signal will be captured.
If no suitable area can be identified, the measurement will not be performed and data will be entered as missing.
Measured: Day 0, day 7, day 14, day 21, day 28 and day 42
Pharmacodynamic endpoints 4 - Change in Morphology by Optical Coherence Tomography (OCT)
Skin morphology will be assessed by optical coherence tomography at every study visit. Optical coherence tomography uses reflected light returning from skin tissue to create an image of the skin and 2 mm below the skin. The visualization can be done because different skin structures reflect light in a different way and can therefore be distinguished. Optical coherence tomography is similar to ultrasound however instead of sound it uses light refraction to visualize tissue.
Measured: Day 0, day 7, day 14, day 21, day 28 and day 42
Pharmacodynamic endpoints 5 - Change in Local skin biopsy biomarkers
Two-millimetre punch biopsies are taken at day 0 and day 28 from a papule or pustule. Moreover, at day 0 a biopsy will be taken from nonlesional non-facial skin (upper back) as healthy control. The biopsies will be placed in RNAlater medium directly after harvest of the biopsy and stored at 4°C. Biomarker sequencing will be performed by RNA extraction and quantitative PCR will be performed for a subset of immunomodulatory biomarkers (including but not limited to IL-1b, IL-1a, TNF-a IL-6, IL-12, IL-8, IL-10, IL-17, IFN-g).
Measured: Day 0 and day 28
Pharmacodynamic endpoints 6 - Change in Local skin surface biomarkers by TAP
Skin biomarkers will be measured pre-dose and after 7, 14, 21, 28, and 42 days by TAP (FibroTx, Estonia). TAP consists of a multiplex capture-antibody micro-array that is supported by a dermal adhesive bandage for fixture to skin. When TAP is applied to skin and left on for 20 minutes, the antibodies printed on the micro-array capture biomarkers from skin through immune recognition.
Biomarkers (IL-1a, IL-1b, TNF-a, IL-8, IL-6, IL-17) captured from skin by TAP are qualitatively and quantitatively analyzed by spot-ELISA by a specific TAP analyzer.
Measured: Day 0, day 7, day 14, day 21, day 28 and day 42
Pharmacodynamic endpoints 7 - Change in skin microbiota
The skin swab will be placed in a 2 ml lysis tube containing DNA/RNA shield to stabilize and preserve the DNA. The DNA extraction will be performed using adapted DNA extraction method based on the Zymo Research fecal DNA extraction methodology. The microbiome will be analyzed according to 16S rRNA gene sampling
Measured: Day 0, day 7, day 14, day 21, day 28 and day 42
Pharmacodynamic endpoints 8 - Change over time in p. acnes cultures
Swabs of predefined lesional (papule of pustule) and non-lesional skin will be taken with a sterile cotton swab. Colony numbers (colony forming units - CFU) and minimal inhibitory concentrations (MIC) will be reported. In addition, swabs of other lesions (i.e. nodules or scars) may be taken if applicable.
Moreover, in order to study P. acnes in the pilosebaceous unit a comedo extraction will be performed and the sebum will be cultured for P. acnes. Comedo extraction will be performed if applicable (i.e. if the patient has comedones).
Measured: Day 0, day 7, day 14, day 21, day 28 and day 42
Pharmacodynamic endpoints 9 - Change over time in faecal microbiota
Faecal samples will be collected at home. Subjects will use a 'faeces catcher' in their toilet and afterwards use a cotton swab to transfer a scoop of faeces to a 2 ml lysis tube (REF ZY-R1103, Zymo Research) containing DNA/RNA shield to stabilize and preserve the DNA.
Measured: before day 0 and after day 28
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Mar 2019
- Study start20 Mar 2018
- Primary completionJun 2019 (estimated)
- Study completionDec 2019 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Acne VulgarisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- A randomized, open-label, placebo-controlled, evaluator-blinded study.
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Centre for Human Drug Research, Netherlands
- Sponsor type
- University, hospital or other
- Collaborators
- Maruho Co., Ltd.
- Responsible party
- Sponsor
- Investigators
- Robert Rissmann, PharmD, PhD, Principal investigator, CHDR
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03883269
- Sponsor's protocol ID
- CHDR1732
- Status last verified
- Mar 2019
- First submitted
- 15 Feb 2018
- Last updated
- 20 Mar 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 20 Mar 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized, Placebo-controlled, Evaluator-blinded, Study to Assess the Anti-inflammatory Effects of Topical Erythromycin and Clindamycin in Patients With Inflammatory Facial Acne
- ClinicalTrials.gov ID
- NCT03883269
- Acronym / sponsor ID
- CHDR1732
- Conditions
- Acne Vulgaris
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- Centre for Human Drug Research, NetherlandsUniversity, hospital or other
- Collaborators
- Maruho Co., Ltd.
- Study start
- 20 Mar 2018 (actual)
- Primary completion
- Jun 2019 (estimated)
- Study completion
- Dec 2019 (estimated)
- First posted
- 20 Mar 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The combined bacteriostatic and immunomodulatory effects of erythromycin and clindamycin will be explored. Treatment effects will be extensively characterized by conventional methods including lesion counts, global assessment scales and visual grading as well as state-of-the-art methodology, including multi-modal photo analysis, perfusion by laser speckle contrast imaging, analysis of local skin surface, biopsy biomarkers and skin microbiota. This extensive response profiling, combined with the mechanistic insights from concurrent in vitro and in vivo studies in healthy volunteer challenges, will increase the understanding of erythromycin's and clindamycin's effects in acne vulgaris.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 3
- Model description
- A randomized, open-label, placebo-controlled, evaluator-blinded study.
| Arm | Type | Receives |
|---|---|---|
| Erythromycin 4% | Experimental | Drug: Erythromycin 4% topical gel formulationErythromycin 4% topical gel formulation, BID, 4 weeks |
| Clindamycin 1% | Experimental | Drug: Clindamycin 1% topical lotion formulationClindamycin 1% topical lotion formulation, BID, 4 weeks |
| ethanol solution | Placebo comparator | Drug: 70% topical ethanol solution70% topical ethanol solution, BID, 4 weeks |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (7 listed)
- Healthy male and female subjects, 18 to 45 years of age. The health status is verified by absence of evidence of any clinical significant active or uncontrolled chronic disease other than AV following a detailed medical history, a complete physical examination including vital signs, 12-lead ECG, hematology, blood chemistry, virology and urinalysis;
- Mild to moderate inflammatory acne vulgaris on the face, ≥5 inflammatory lesions (papules and/or pustules), present at screening and baseline visit
- A maximum of 5 nodules present at screening and baseline visit
- Inflammatory acne present for at least 6 months
- Fitzpatrick skin type I-II (Caucasian)
Key exclusion criteria (11 listed)
- Severe acne where systemic treatment is needed
- Use of any topical (anti-acne) medication (prescription or OTC) within 2 weeks prior to baseline
- Use of any oral/systemic treatment for acne, including oral antibiotics, excluding OAC, within 4 weeks prior to baseline
- Use of systemic isotretinoin within 6 months prior to baseline
- History of pathological scar formation (keloid, hypertrophic scar)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Erythromycin 4% topical gel formulationErythromycin 4% topical gel formulation, BID, 4 weeks | Drug | Erythromycin 4% |
| Clindamycin 1% topical lotion formulationClindamycin 1% topical lotion formulation, BID, 4 weeks | Drug | Clindamycin 1% |
| 70% topical ethanol solution70% topical ethanol solution, BID, 4 weeks | Drug | ethanol solution |
Primary outcome
Efficacy endpoint 1 - Change in lesion count
Time frame: Day 0, day 7, day 14, day 21, day 28 and day 42
The inflammatory lesions include papules pustules and nodules/cysts. At screening and every study visit, the evaluator will count the inflammatory lesions separately by area on the face (forehead, right cheek, left cheek, chin and nose). All lesion counts during the treatment and follow-up period will be performed by a treatment-blinded evaluator
Efficacy endpoint 2 - Change in investigator Global Assessment acne (IGA)
Time frame: Day 0, day 7, day 14, day 21, day 28 and day 42
Acne severity will be assessed at screening and every study visit by the Investigator Global Assessment for facial acne (clear, almost clear, mild, moderate, severe, very severe). This will be done by a treatment blinded evaluator.
Change in Patient Reported Outcome (PRO)
Time frame: Day 0 and day 28
Pre-dose and at EOT patients will be asked how they would rate their acne that day using the subjective Patient Global Assessment (clear, almost clear, mild, moderate, severe, very severe)
Pharmacodynamic endpoints 1 - Change in Standardized facial photography by Canfield Visia and via selfie app
Time frame: Day 0, day 7, day 14, day 21, day 28 and day 42
A standardized set of 3 facial photos (front, left, right) will be taken every study visit by Canfield Visia CR. Furthermore, patients will take daily selfies with a validated mobile app.
Pharmacodynamic endpoints 2 - Change in Sebum measurements by Sebumeter®
Time frame: Day 0, day 7, day 14, day 21, day 28 and day 42
Sebum excretion will be measured every study visit by Sebumeter®. The measurement will be repeated for 3 times and the average will be used for the analysis.
Pharmacodynamic endpoints 3 - Change in Perfusion by Laser Speckle Contrast Imaging (LSCI)
Time frame: Day 0, day 7, day 14, day 21, day 28 and day 42
Cutaneous microcirculation will be assessed using the laser speckle imager (LSCI; PeriCam PSI System, Perimed Jäfälla, Sweden). Measurements have to be performed in a temperature controlled room with a temperature around 22°C. The subject has to get accommodated to the room temperature for a minimum of 15 minutes prior to testing. After this, the speckle assessments can commence. Briefly, the subject will be resting for at least ten minutes before any measurements take place. A suitable area of the face will be identified. This area will be illuminated' by the laser and the response signal will be captured. If no suitable area can be identified, the measurement will not be performed and data will be entered as missing.
Pharmacodynamic endpoints 4 - Change in Morphology by Optical Coherence Tomography (OCT)
Time frame: Day 0, day 7, day 14, day 21, day 28 and day 42
Skin morphology will be assessed by optical coherence tomography at every study visit. Optical coherence tomography uses reflected light returning from skin tissue to create an image of the skin and 2 mm below the skin. The visualization can be done because different skin structures reflect light in a different way and can therefore be distinguished. Optical coherence tomography is similar to ultrasound however instead of sound it uses light refraction to visualize tissue.
Pharmacodynamic endpoints 5 - Change in Local skin biopsy biomarkers
Time frame: Day 0 and day 28
Two-millimetre punch biopsies are taken at day 0 and day 28 from a papule or pustule. Moreover, at day 0 a biopsy will be taken from nonlesional non-facial skin (upper back) as healthy control. The biopsies will be placed in RNAlater medium directly after harvest of the biopsy and stored at 4°C. Biomarker sequencing will be performed by RNA extraction and quantitative PCR will be performed for a subset of immunomodulatory biomarkers (including but not limited to IL-1b, IL-1a, TNF-a IL-6, IL-12, IL-8, IL-10, IL-17, IFN-g).
Pharmacodynamic endpoints 6 - Change in Local skin surface biomarkers by TAP
Time frame: Day 0, day 7, day 14, day 21, day 28 and day 42
Skin biomarkers will be measured pre-dose and after 7, 14, 21, 28, and 42 days by TAP (FibroTx, Estonia). TAP consists of a multiplex capture-antibody micro-array that is supported by a dermal adhesive bandage for fixture to skin. When TAP is applied to skin and left on for 20 minutes, the antibodies printed on the micro-array capture biomarkers from skin through immune recognition. Biomarkers (IL-1a, IL-1b, TNF-a, IL-8, IL-6, IL-17) captured from skin by TAP are qualitatively and quantitatively analyzed by spot-ELISA by a specific TAP analyzer.
Pharmacodynamic endpoints 7 - Change in skin microbiota
Time frame: Day 0, day 7, day 14, day 21, day 28 and day 42
The skin swab will be placed in a 2 ml lysis tube containing DNA/RNA shield to stabilize and preserve the DNA. The DNA extraction will be performed using adapted DNA extraction method based on the Zymo Research fecal DNA extraction methodology. The microbiome will be analyzed according to 16S rRNA gene sampling
Pharmacodynamic endpoints 8 - Change over time in p. acnes cultures
Time frame: Day 0, day 7, day 14, day 21, day 28 and day 42
Swabs of predefined lesional (papule of pustule) and non-lesional skin will be taken with a sterile cotton swab. Colony numbers (colony forming units - CFU) and minimal inhibitory concentrations (MIC) will be reported. In addition, swabs of other lesions (i.e. nodules or scars) may be taken if applicable. Moreover, in order to study P. acnes in the pilosebaceous unit a comedo extraction will be performed and the sebum will be cultured for P. acnes. Comedo extraction will be performed if applicable (i.e. if the patient has comedones).
Pharmacodynamic endpoints 9 - Change over time in faecal microbiota
Time frame: before day 0 and after day 28
Faecal samples will be collected at home. Subjects will use a 'faeces catcher' in their toilet and afterwards use a cotton swab to transfer a scoop of faeces to a 2 ml lysis tube (REF ZY-R1103, Zymo Research) containing DNA/RNA shield to stabilize and preserve the DNA.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Mar 2019.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Robert Rissmann, PharmD, PhD principal investigator
CHDR
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Erythromycin 4% topical gel formulation, Clindamycin 1% topical lotion formulation and 70% topical ethanol solution in people with Acne Vulgaris, run by Centre for Human Drug Research, Netherlands at 1 site in Netherlands.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 20 Mar 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Netherlands. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Robert Rissmann, PharmD, PhD (+31 71 5246 400, clintrials@chdr.nl), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Efficacy endpoint 1 - Change in lesion count (time frame: Day 0, day 7, day 14, day 21, day 28 and day 42). The study lists 12 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 Mar 2019.