Nasolabial Fold, HypoplasticNCT04101825
MD Auralia (HA Filler) in Treatment of Nasolabial Wrinkles
A study testing Auralya in people with Nasolabial Fold, Hypoplastic, run by I.R.A. Istituto Ricerche Applicate S.p.A. at 1 site in Romania.
Trial summary
Auralya® is a sterile, injectable, non-pyrogenic, re-absorbable medical product made of reticulated hyaluronic acid of non-animal origin, produced via bacterial fermentation. To evaluate the overall safety of the medical device and performance of Auralya® dermal filler in terms of absolute change of WSRS score… Read more about this study
- Who is it for?
- Ages 35 to 65 years
- Conditions the study is for
- Nasolabial Fold, Hypoplastic
- What is being tested?
- Auralya
- Type of treatment
- Injection or infusion, Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteRomania
- Study dates
- 16 Sep 2020to 16 Mar 2021
- Phase
- Interventional
- Are there results?
- None posted in the registry
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 35 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Men or women with age > 35 and ≤ 65 years.
- Subjects with nasolabial wrinkles, seeking tissue augmentation treatment and willing to receive HA Filler;
- Subjects presenting a score of 2 (shallow wrinkles) or 3 (moderate, deep wrinkles) on the Wrinkles Severity Ranking Scale (WSRS);
- Subjects who agree to discontinue all dermatological treatment and procedures during the study;
- Subjects willing to provide signed informed consent to clinical investigation participation.
- Able to communicate adequately with the Investigator and to comply with the requirements for the entire study.
Who cannot join
- Subjects who have bleeding disorder in the past or present.
- Use of aspirin and antiplatelet agents a week prior to treatment
- Prior or planned use of topical injection to the face (steroid, retinoid: applicable only to drugs, not applicable to cosmetics), within 4 weeks prior to screening or during this study (steroid ointment for therapeutic objectives is allowed for short -term use of ≤14 consecutive days.).
- Use of immunosuppressive, chemotherapies, or systemic corticosteroids within 12 weeks from screening.
- History of anaphylaxis or severe complicated allergy symptoms.
- Clinically significant cardiovascular, digestive, respiratory, endocrine, or central nervous system disorders or previous mental disorders that may significantly affect the study.
Show all 19Show fewer
- Hypersensitivity skin reaction to the investigational device based on intradermal test results at screening.
- Evidence or history of autoimmune disease or compromised immune system.
- Treatment with anticoagulants, thrombolytics, or platelet inhibitors within 1 week prior to study participation;
- Prior permanent fillers or fat graft procedures around nasolabial folds.
- Wrinkle correction procedures (e.g., botulinum toxin A injection, face lift, soft tissue augmentation, medium-depth peel, dermal photorejuvenation, etc.) within 6 months prior to study participation.
- History of hypersensitivity to local anesthetic of amide type or HA.
- History of keloid formation or hypertrophic scar on the face.
- Evidence of active infection on the face.
- Wound, scar, or skin disorder or infection around nasolabial folds that may affect the efficacy assessment.
- Pregnant woman, lactating woman, and man or woman of childbearing potential who is planning a pregnancy or is unwilling to use appropriate methods of contraception* during the study, *Methods of contraception: hormonal contraceptive, intrauterine device or intrauterine system, double barrier method (condom with spermicide/diaphragm or cervical cap with spermicide), surgical sterilization (vasectomy, tubal ligation, etc.).
- As with all dermal filler procedures, the product should not be used in vascular rich areas.
- Subjects with illness, or other medical condition that, in the opinion of the investigator, would compromise participation or be likely to lead to hospitalization during the study.
- Participation in an interventional clinical study or administration of any investigational agents in the previous 30 days
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Open, Non-comparative Study to Evaluate the Performance and Safety of the Medical Device AURALYA® (Hyaluronic Acid-dermal Filler) in the Treatment of Nasolabial Wrinkles to Obtain Facial Rejuvenation
Auralya® is a sterile, injectable, non-pyrogenic, re-absorbable medical product made of reticulated hyaluronic acid of non-animal origin, produced via bacterial fermentation.
To evaluate the overall safety of the medical device and performance of Auralya® dermal filler in terms of absolute change of WSRS score (Wrinkle Severity Rating Scale) assessed by Investigator at 8 and 12 weeks after the initiation of treatment, compared to Baseline Visit (day 0).
Read the detailed description
Minimally invasive procedures (injectable dermal fillers) are among the techniques preferred by an increasing number of specialists in Aesthetics due to their clinical performance regarding volume restoration, and favourable safety profile.
During January - March 2018, it was performed a review of the scientific literature to find similar investigations to determine the minimal clinical significant difference between Baseline and a period of 30 days after the end the treatment.
In a similar dermal filler study, Takanobu Mashiko et al used a 5-grade WSRS and showed that, at 4 weeks after treatment, they achieved a 1.7 ± 0.5 (mean ± SD) improvement between those visits.
Considering the exploratory nature of this study and the fact that this investigation is first in-human, we choose to take a 0.5 WSRS decrease, at 90 days from the treatment start, as a minimal clinically significant difference. The standard deviation considered for the sample size calculation was set at 0.8 WSRS points.
By using a one-sided Wilcoxon Signed-rank test (matched pairs), a significance level of 0.05 and a power of 0.95 (probability of finding an effect when there is one), we calculated a total sample size of 31 subjects.
- Conditions
- Nasolabial Fold, Hypoplastic
- Being tested
- Auralya
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
AuralyaDevice
Hyaluronic Acid-Dermal Filler
| Study group | Role | What they receive |
|---|---|---|
| Auralya | Experimental | Auralya® 25 (Cross-linked Hyaluronic Acid) Injection Receives: Device: Auralya |
What is being measured
The primary outcome is the main question the study is designed to answer.
Evaluate safety and performance of Auralya
To evaluate the overall safety of the medical device and performance of Auralya® dermal filler in terms of absolute change of Wrinkle Severity Rating Scale assessed by Investigator at 8 and 12 weeks after the initiation of treatment, compared to Baseline Visit (day 0).
Measured: 12 weeks
Secondary outcomes (5)
Change of Wrinkle Severity Rating Scale
Absolute change of WSRS score assessed by the subject at 2, 4, 8 and 12 weeks compared to Baseline Visit (day 0).
Measured: 12 weeks
General appearance after treatment
General appearance after treatment assessed by the subject at 2, 4, 8 and 12 weeks after the first treatment session compared to Baseline Visit (day 0) using the Global Aesthetic Improvement Scale (GAIS)
Measured: 12 weeks
Subject satisfaction
Subject satisfaction assessed at 2, 4, 8 and 12 weeks, through Treatment Satisfaction Questionnaire completed by the subject providing their degree of satisfaction with the treatment on a three-point scale (very satisfied, satisfied, or not satisfied)
Measured: 12 weeks
Global evaluation of product performance
Global evaluation of product performance by Investigator with photos taken at each visit. The photos will be compared in the final visit (week 12)
Measured: 12 weeks
Product safety
Global evaluation of product safety by Investigator and by the patient using Patient Global Assessment of Safety questionnaire
Measured: 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Sep 2019
- Study start16 Sep 2020
- Primary completion16 Mar 2021
- Study completion16 Mar 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (22)Papers the sponsor has linked to this study.
- Other trials for Nasolabial Fold, HypoplasticStudies 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 N/A
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- This trial is open label, multi-center, non-randomized single group.
- Masking
- None (open label)
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- I.R.A. Istituto Ricerche Applicate S.p.A.
- Sponsor type
- Research network
- Collaborators
- Opera CRO, a TIGERMED Group Company
- Responsible party
- Sponsor
- Investigators
- Mihaela Fratila, MD, Principal investigator, SCM Dr. Rosu
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04101825
- Sponsor's protocol ID
- OPIRA/0219/MD
- Status last verified
- Apr 2021
- First submitted
- 20 Sep 2019
- Last updated
- 12 Apr 2021
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Fitzgerald R, Graivier MH, Kane M, Lorenc ZP, Vleggaar D, Werschler WP, Kenkel JM. Update on facial aging. Aesthet Surg J. 2010 Jul-Aug;30 Suppl:11S-24S. doi: 10.1177/1090820X10378696.
PubMed 20844296Sudha PN, Rose MH. Beneficial effects of hyaluronic acid. Adv Food Nutr Res. 2014;72:137-176. doi: 10.1016/B978-0-12-800269-8.00009-9.
PubMed 25081082Kim BW, Moon IJ, Yun WJ, Chung BY, Kim SD, Lee GY, Chang SE. A Randomized, Evaluator-Blinded, Split-Face Comparison Study of the Efficacy and Safety of a Novel Mannitol Containing Monophasic Hyaluronic Acid Dermal Filler for the Treatment of Moderate to Severe Nasolabial Folds. Ann Dermatol. 2016 Jun;28(3):297-303. doi: 10.5021/ad.2016.28.3.297. Epub 2016 May 25.
PubMed 27274627Kopera D, Palatin M, Bartsch R, Bartsch K, O'Rourke M, Holler S, Baumgartner RR, Prinz M. An open-label uncontrolled, multicenter study for the evaluation of the efficacy and safety of the dermal filler Princess VOLUME in the treatment of nasolabial folds. Biomed Res Int. 2015;2015:195328. doi: 10.1155/2015/195328. Epub 2015 Mar 3.
PubMed 25821787Few J, Cox SE, Paradkar-Mitragotri D, Murphy DK. A Multicenter, Single-Blind Randomized, Controlled Study of a Volumizing Hyaluronic Acid Filler for Midface Volume Deficit: Patient-Reported Outcomes at 2 Years. Aesthet Surg J. 2015 Jul;35(5):589-99. doi: 10.1093/asj/sjv050. Epub 2015 May 11.
PubMed 25964628Callan P, Goodman GJ, Carlisle I, Liew S, Muzikants P, Scamp T, Halstead MB, Rogers JD. Efficacy and safety of a hyaluronic acid filler in subjects treated for correction of midface volume deficiency: a 24 month study. Clin Cosmet Investig Dermatol. 2013 Mar 20;6:81-9. doi: 10.2147/CCID.S40581. Print 2013.
PubMed 23687448Dong J, Gantz M, Goldenberg G. Efficacy and safety of new dermal fillers. Cutis. 2016 Nov;98(5):309-313.
PubMed 28040813De Boulle K, Heydenrych I. Patient factors influencing dermal filler complications: prevention, assessment, and treatment. Clin Cosmet Investig Dermatol. 2015 Apr 15;8:205-14. doi: 10.2147/CCID.S80446. eCollection 2015.
PubMed 25926750Rivkin AZ. Volume correction in the aging hand: role of dermal fillers. Clin Cosmet Investig Dermatol. 2016 Aug 30;9:225-32. doi: 10.2147/CCID.S92853. eCollection 2016.
PubMed 27621659Kuhne U, Esmann J, von Heimburg D, Imhof M, Weissenberger P, Sattler G. Safety and performance of cohesive polydensified matrix hyaluronic acid fillers with lidocaine in the clinical setting - an open-label, multicenter study. Clin Cosmet Investig Dermatol. 2016 Oct 20;9:373-381. doi: 10.2147/CCID.S115256. eCollection 2016.
PubMed 27799807Lorenc ZP, Bank D, Kane M, Lin X, Smith S. Validation of a four-point photographic scale for the assessment of midface volume loss and/or contour deficiency. Plast Reconstr Surg. 2012 Dec;130(6):1330-1336. doi: 10.1097/PRS.0b013e31826d9fa6.
PubMed 23190816Chen WY, Abatangelo G. Functions of hyaluronan in wound repair. Wound Repair Regen. 1999 Mar-Apr;7(2):79-89. doi: 10.1046/j.1524-475x.1999.00079.x.
PubMed 10231509McCall-Perez F, Stephens TJ, Herndon JH Jr. Efficacy and tolerability of a facial serum for fine lines, wrinkles, and photodamaged skin. J Clin Aesthet Dermatol. 2011 Jul;4(7):51-4.
PubMed 21779421Rzany B, Cartier H, Kestemont P, Trevidic P, Sattler G, Kerrouche N, Dhuin JC, Ma YM. Full-face rejuvenation using a range of hyaluronic acid fillers: efficacy, safety, and patient satisfaction over 6 months. Dermatol Surg. 2012 Jul;38(7 Pt 2):1153-61. doi: 10.1111/j.1524-4725.2012.02470.x.
PubMed 22759252Van Dyke S, Hays GP, Caglia AE, Caglia M. Severe Acute Local Reactions to a Hyaluronic Acid-derived Dermal Filler. J Clin Aesthet Dermatol. 2010 May;3(5):32-5.
PubMed 20725567
Study at a glance
From the registry record, last updated by the sponsor on 12 Apr 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Open, Non-comparative Study to Evaluate the Performance and Safety of the Medical Device AURALYA® (Hyaluronic Acid-dermal Filler) in the Treatment of Nasolabial Wrinkles to Obtain Facial Rejuvenation
- ClinicalTrials.gov ID
- NCT04101825
- Acronym / sponsor ID
- OPIRA/0219/MD
- Conditions
- Nasolabial Fold, Hypoplastic
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- I.R.A. Istituto Ricerche Applicate S.p.A.Research network
- Collaborators
- Opera CRO, a TIGERMED Group Company
- Study start
- 16 Sep 2020 (actual)
- Primary completion
- 16 Mar 2021 (actual)
- Study completion
- 16 Mar 2021 (actual)
- First posted
- 24 Sep 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.
Auralya® is a sterile, injectable, non-pyrogenic, re-absorbable medical product made of reticulated hyaluronic acid of non-animal origin, produced via bacterial fermentation.
To evaluate the overall safety of the medical device and performance of Auralya® dermal filler in terms of absolute change of WSRS score (Wrinkle Severity Rating Scale) assessed by Investigator at 8 and 12 weeks after the initiation of treatment, compared to Baseline Visit (day 0).
Detailed description
Minimally invasive procedures (injectable dermal fillers) are among the techniques preferred by an increasing number of specialists in Aesthetics due to their clinical performance regarding volume restoration, and favourable safety profile.
During January - March 2018, it was performed a review of the scientific literature to find similar investigations to determine the minimal clinical significant difference between Baseline and a period of 30 days after the end the treatment.
In a similar dermal filler study, Takanobu Mashiko et al used a 5-grade WSRS and showed that, at 4 weeks after treatment, they achieved a 1.7 ± 0.5 (mean ± SD) improvement between those visits.
Considering the exploratory nature of this study and the fact that this investigation is first in-human, we choose to take a 0.5 WSRS decrease, at 90 days from the treatment start, as a minimal clinically significant difference. The standard deviation considered for the sample size calculation was set at 0.8 WSRS points.
By using a one-sided Wilcoxon Signed-rank test (matched pairs), a significance level of 0.05 and a power of 0.95 (probability of finding an effect when there is one), we calculated a total sample size of 31 subjects.
Study design
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- This trial is open label, multi-center, non-randomized single group.
| Arm | Type | Receives |
|---|---|---|
| Auralya | Experimental | Device: AuralyaAuralya® 25 (Cross-linked Hyaluronic Acid) Injection |
Who may qualify
- Ages
- 35 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Men or women with age > 35 and ≤ 65 years.
- Subjects with nasolabial wrinkles, seeking tissue augmentation treatment and willing to receive HA Filler;
- Subjects presenting a score of 2 (shallow wrinkles) or 3 (moderate, deep wrinkles) on the Wrinkles Severity Ranking Scale (WSRS);
- Subjects who agree to discontinue all dermatological treatment and procedures during the study;
- Subjects willing to provide signed informed consent to clinical investigation participation.
Key exclusion criteria (19 listed)
- Subjects who have bleeding disorder in the past or present.
- Use of aspirin and antiplatelet agents a week prior to treatment
- Prior or planned use of topical injection to the face (steroid, retinoid: applicable only to drugs, not applicable to cosmetics), within 4 weeks prior to screening or during this study (steroid ointment for therapeutic objectives is allowed for short -term use of ≤14 consecutive days.).
- Use of immunosuppressive, chemotherapies, or systemic corticosteroids within 12 weeks from screening.
- History of anaphylaxis or severe complicated allergy symptoms.
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 |
|---|---|---|
| AuralyaHyaluronic Acid-Dermal Filler | Device | Auralya |
Primary outcome
Evaluate safety and performance of Auralya
Time frame: 12 weeks
To evaluate the overall safety of the medical device and performance of Auralya® dermal filler in terms of absolute change of Wrinkle Severity Rating Scale assessed by Investigator at 8 and 12 weeks after the initiation of treatment, compared to Baseline Visit (day 0).
5 secondary outcomes
Change of Wrinkle Severity Rating Scale
Time frame: 12 weeks
General appearance after treatment
Time frame: 12 weeks
Subject satisfaction
Time frame: 12 weeks
Global evaluation of product performance
Time frame: 12 weeks
Product safety
Time frame: 12 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Apr 2021.
- Background: PubMed 20844296Fitzgerald R, Graivier MH, Kane M, Lorenc ZP, Vleggaar D, Werschler WP, Kenkel JM. Update on facial aging. Aesthet Surg J. 2010 Jul-Aug;30 Suppl:11S-24S. doi: 10.1177/1090820X10378696.
- Background: PubMed 25081082Sudha PN, Rose MH. Beneficial effects of hyaluronic acid. Adv Food Nutr Res. 2014;72:137-176. doi: 10.1016/B978-0-12-800269-8.00009-9.
- Background: PubMed 27274627Kim BW, Moon IJ, Yun WJ, Chung BY, Kim SD, Lee GY, Chang SE. A Randomized, Evaluator-Blinded, Split-Face Comparison Study of the Efficacy and Safety of a Novel Mannitol Containing Monophasic Hyaluronic Acid Dermal Filler for the Treatment of Moderate to Severe Nasolabial Folds. Ann Dermatol. 2016 Jun;28(3):297-303. doi: 10.5021/ad.2016.28.3.297. Epub 2016 May 25.
- Background: PubMed 25821787Kopera D, Palatin M, Bartsch R, Bartsch K, O'Rourke M, Holler S, Baumgartner RR, Prinz M. An open-label uncontrolled, multicenter study for the evaluation of the efficacy and safety of the dermal filler Princess VOLUME in the treatment of nasolabial folds. Biomed Res Int. 2015;2015:195328. doi: 10.1155/2015/195328. Epub 2015 Mar 3.
- Background: PubMed 25964628Few J, Cox SE, Paradkar-Mitragotri D, Murphy DK. A Multicenter, Single-Blind Randomized, Controlled Study of a Volumizing Hyaluronic Acid Filler for Midface Volume Deficit: Patient-Reported Outcomes at 2 Years. Aesthet Surg J. 2015 Jul;35(5):589-99. doi: 10.1093/asj/sjv050. Epub 2015 May 11.
- Background: PubMed 23687448Callan P, Goodman GJ, Carlisle I, Liew S, Muzikants P, Scamp T, Halstead MB, Rogers JD. Efficacy and safety of a hyaluronic acid filler in subjects treated for correction of midface volume deficiency: a 24 month study. Clin Cosmet Investig Dermatol. 2013 Mar 20;6:81-9. doi: 10.2147/CCID.S40581. Print 2013.
- Background: PubMed 28040813Dong J, Gantz M, Goldenberg G. Efficacy and safety of new dermal fillers. Cutis. 2016 Nov;98(5):309-313.
- Background: PubMed 25926750De Boulle K, Heydenrych I. Patient factors influencing dermal filler complications: prevention, assessment, and treatment. Clin Cosmet Investig Dermatol. 2015 Apr 15;8:205-14. doi: 10.2147/CCID.S80446. eCollection 2015.
- Background: PubMed 27621659Rivkin AZ. Volume correction in the aging hand: role of dermal fillers. Clin Cosmet Investig Dermatol. 2016 Aug 30;9:225-32. doi: 10.2147/CCID.S92853. eCollection 2016.
- Background: PubMed 27799807Kuhne U, Esmann J, von Heimburg D, Imhof M, Weissenberger P, Sattler G. Safety and performance of cohesive polydensified matrix hyaluronic acid fillers with lidocaine in the clinical setting - an open-label, multicenter study. Clin Cosmet Investig Dermatol. 2016 Oct 20;9:373-381. doi: 10.2147/CCID.S115256. eCollection 2016.
- Background: PubMed 23190816Lorenc ZP, Bank D, Kane M, Lin X, Smith S. Validation of a four-point photographic scale for the assessment of midface volume loss and/or contour deficiency. Plast Reconstr Surg. 2012 Dec;130(6):1330-1336. doi: 10.1097/PRS.0b013e31826d9fa6.
- Background: PubMed 10231509Chen WY, Abatangelo G. Functions of hyaluronan in wound repair. Wound Repair Regen. 1999 Mar-Apr;7(2):79-89. doi: 10.1046/j.1524-475x.1999.00079.x.
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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. This study is not recruiting at the moment.
Mihaela Fratila, MD principal investigator
SCM Dr. Rosu
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Auralya in people with Nasolabial Fold, Hypoplastic, run by I.R.A. Istituto Ricerche Applicate S.p.A. at 1 site in Romania.
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 6 inclusion and 19 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: finished, as of the sponsor's last update on 12 Apr 2021. 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 Romania. 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. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Evaluate safety and performance of Auralya (time frame: 12 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04101825, which also lists 22 linked publications.
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 12 Apr 2021.