Acne ScarNCT04648995
TheTreatment of Acne Scar Using UltraPulse CO2 Laser
A study testing High energy (UltraPulse) and Low energy (UltraPulse) in people with Acne Scar, run by Haute Beauté Skin & Vein Clinic at 1 site in Taiwan.
Trial summary
Purpose of the study is to assess the effect and evaluate topographic volume changes of UltraPulse at treating boxcar scars with different energy and the effect of UltraPulse at treating icepick scars. Read more about this study
- Who is it for?
- Ages 20 to 60 yearsHealthy volunteers can take part
- Conditions the study is for
- Acne Scar
- What is being tested?
- High energy (UltraPulse) and Low energy (UltraPulse)
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 1 siteTaiwan
- Study dates
- 11 Dec 2020to 28 Nov 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 20 to 60 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Subjects have to be aged from 20 to 60 year-old
- Subjects currently have an area of involvement approximately 2cm × 2cm on each side of the face over the temples or cheek bone area
- Classified as mild to moderate acne scar according to global severity of facial acne scar (GSAAS) score
- After evaluation by clinician, those subjects to be treated with "Lumenis"CO2 Laser System (UltraPulse) can benefit from this laser treatment
- Subjects need to be fully functional and aware of the pros and cons of the study. Subject is capable to make self judgement and sign the inform consent under his/her own will
- Others: Have fully understand about this study and is willing to cooperate with the instruction of the study
Who cannot join
- Those who were known to have keloid formation
- Those who have porphyria or known photosensitivity
- Those who previously underwent laser therapy treatment or skin biopsy and have showed poor result or adverse effect
- Those who were classified as "severe" according to GSAAS system
- Those who have bleeding tendency
- Those who present with clinical data suggesting abnormal platelet function or coagulation disorder (such as prolonged aPTT or PT)
Show all 17Show fewer
- Those that are currently taking anticoagulants or anti-platelet drugs
- Those who are on aspirin or other NSAIDs
- Those who have history of granulomatous or connective tissue disease
- Female subjects with a positive pregnancy test
- Women who refuse to stay on effective contraception or refuse pregnancy tests during the study
- After evaluation by the clinician, those that have been enrolled in clinical studies over the past 6 months that may alter the current study result
- After evaluation by the clinician, those currently or had previous treatment of atrophic acne scars with fillers, lasers, deep chemical peels, or any other medical or surgical treatment which in the investigators' opinion could alter the results of the current clinical study
- Those that are currently taking photo-sensitive drugs, oral isotretinoin, iron supplement or other herbal medication
- Those that have received laser treatment over the lesion area over the past 3 months
- Those that are currently pregnant or breastfeeding
- After evaluation by the clinician, and concluded underline epilepsy, area to be treated is under infection or ulceration, poor wound healing)
Trial locations and contacts
1 site in 1 country.
Taiwan1 site, 1 recruiting
- Recruiting
HAUTE BEAUTÉ Skin & Vein Clinic
Taipei, 110
Claire Lai, +886-2-8787-2112, clinklj@gmail.com
About this study
Official title: A Single-Blinded Split Face Prospective Study Comparing Different Energy, Efficacy, and Safety of UltraPulse CO2 Laser in the Treatment of Acne Scar Using Antera Quantitative 3D Image Analysis
Purpose of the study is to assess the effect and evaluate topographic volume changes of UltraPulse at treating boxcar scars with different energy and the effect of UltraPulse at treating icepick scars.
Read the detailed description
After being informed about the study and potential risks, all patients giving written informed consent will undergo a 24 hour screening period to determine eligibility for study entry. Upon enrollment, patient who fulfill all the inclusion criteria and does not fulfill any exclusion criteria will be scheduled for their visits.
All subjects will be receiving two sessions of treatment, with the two sessions 8-12 weeks apart. Subjects' face will be divided to left and right, with each side randomized to receive a low versus high energy setting. In the low energy setting side of the face, central base of boxcar scar will be treated with 20mJ, while shoulder of scar will be treated with 50 mJ. In the high energy setting side of the face, central base of boxcar scar will be treated with 30mJ, while shoulder of scar will be treated with 60 mJ. Subject will be blinded regarding which side of the face received low versus high energy setting.
Ultrasound will be used to assess epidermal and dermal thickness change at the treated area. This will be performed before the 1st and 2nd treatment session as well as one month and three month after the 2nd treatment session.
Antera Quantitative 3D Image Analysis will be performed before and after the 1st and 2nd treatment session as well as one month and three month after the 2nd treatment session.
3mm punch biopsy will be taken from 10 volunteers over bilateral face before the 1st treatment session and 3 month after the 2nd treatment session (total of 4 sample will be obtained in each volunteer). Skin specimen will be stained with hematoxylin and eosin as well as relevant stain for collagen and elastic fiber.
Clinical photograph will be taken before and after the 1st and 2nd treatment session as well as one month and three month after the 2nd treatment session. Two blinded board certified dermatologist will be asked to rate the improvement of acne scar by GSAAS according to the clinical photograph taken.
All subjects will be asked to rate their satisfaction regarding treatment response over each side of the face using a 0 to 10 point scale chart.
- Conditions
- Acne Scar
- Being tested
- High energy (UltraPulse), Low energy (UltraPulse)
- Keywords
- UltraPulse CO2 Laser, Antera Quantitative 3D Image, Collagen, Elastic fiber, Scale for global severity of facial acne scar
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
High energy (UltraPulse)Device
Half of the face that receives low energy, their central base of boxcar scar will be treated with 30mJ, while shoulder of scar will be treated with 60 mJ
Low energy (UltraPulse)Device
Half of the face that receives low energy, their central base of boxcar scar will be treated with 20mJ, while shoulder of scar will be treated with 50 mJ
| Study group | Role | What they receive |
|---|---|---|
| High energy | Other | Half of the face that receives low energy, their central base of boxcar scar will be treated with 30mJ, while shoulder of scar will be treated with 60 mJ Receives: Device: High energy (UltraPulse) |
| Low energy | Other | Half of the face that receives low energy, their central base of boxcar scar will be treated with 20mJ, while shoulder of scar will be treated with 50 mJ Receives: Device: Low energy (UltraPulse) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Topographic volume changes of acne scars from baseline one month and three month after the 2nd treatment session
Topographic volume changes of acne scars from baseline one month and three month after the 2nd treatment session
Measured: from baseline one month and three month after the 2nd treatment session
Histological change in epidermal/dermal component including elastic fiber and collagen synthesis three month after the 2nd treatment session from baseline
Histological change in epidermal/dermal component including elastic fiber and collagen synthesis three month after the 2nd treatment session from baseline
Measured: three month after the 2nd treatment session from baseline
Secondary outcomes (5)
Access improvement of acne scar by Scale for global severity of facial acne scar from baseline one month and three month after the 2nd treatment session in both the low and high energy treated arm
Access improvement of acne scar by Scale for global severity of facial acne scar from baseline one month and three month after the 2nd treatment session in both the low and high energy treated arm. The minimum and maximum values of Scale for global severity of facial acne scar are 0 and 5, and higher scores mean a worse outcome.
Measured: from baseline one month and three month after the 2nd treatment session
Compare the difference of improvement of acne scar by Scale for global severity of facial acne scar in the low versus high energy treated arm
Compare the difference of improvement of acne scar by Scale for global severity of facial acne scar in the low versus high energy treated arm. The minimum and maximum values of Scale for global severity of facial acne scar are 0 and 5, and higher scores mean a worse outcome.
Measured: from baseline and three month after the 2nd treatment session
Compare the difference of newly synthesis collagen and elastic fiber through staining in the low versus high energy treated arm
Compare the difference of newly synthesis collagen and elastic fiber through staining in the low versus high energy treated arm
Measured: from baseline and three month after the 2nd treatment session
Assess the frequency and severity of encountered side effects in the low versus high energy treated arm
Assess the frequency and severity of encountered side effects in the low versus high energy treated arm
Measured: from baseline and three month after the 2nd treatment session
Subjects' satisfaction score rated in a 0 to 10 point scale
Subjects' satisfaction score rated in a 0 to 10 point scale
Measured: after the 2nd treatment session、one month and three month after the 2nd treatment session
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Dec 2020
- Study start11 Dec 2020
- Primary completion8 Sep 2021 (estimated)
- Study completion28 Nov 2021 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (9)Papers the sponsor has linked to this study.
- Other trials for Acne ScarStudies 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Low energy: Half of the face that receives low energy, their central base of boxcar scar will be treated with 20mJ, while shoulder of scar will be treated with 50 mJ High energy: Half of the face that receives low energy, their central base of boxcar scar will be treated with 30mJ, while shoulder of scar will be treated with 60 mJ
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 20 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Haute Beauté Skin & Vein Clinic
- Sponsor type
- University, hospital or other
- Collaborators
- Lumenis Be Ltd., Taipei Medical University Shuang Ho Hospital
- Responsible party
- Principal investigator, Kuo-Liang Cheng, Haute Beauté Skin & Vein Clinic
- Investigators
- Kuo-Liang Cheng, MD, Principal investigator, Haute Beauté Skin & Vein Clinic
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04648995
- Sponsor's protocol ID
- N202007052
- Status last verified
- Nov 2020
- First submitted
- 24 Nov 2020
- Last updated
- 3 Jun 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Dreno B, Thiboutot D, Layton AM, Berson D, Perez M, Kang S; Global Alliance to Improve Outcomes in Acne. Large-scale international study enhances understanding of an emerging acne population: adult females. J Eur Acad Dermatol Venereol. 2015 Jun;29(6):1096-106. doi: 10.1111/jdv.12757. Epub 2014 Oct 8.
PubMed 25296739Bhargava S, Kumar U, Varma K. Subcision and Microneedling as an Inexpensive and Safe Combination to Treat Atrophic Acne Scars in Dark Skin: A Prospective Study of 45 Patients at a Tertiary Care Center. J Clin Aesthet Dermatol. 2019 Aug;12(8):18-22. Epub 2019 Aug 1.
PubMed 31531167Jacob CI, Dover JS, Kaminer MS. Acne scarring: a classification system and review of treatment options. J Am Acad Dermatol. 2001 Jul;45(1):109-17. doi: 10.1067/mjd.2001.113451.
PubMed 11423843Alster TS, Li MKY. Microneedling of Scars: A Large Prospective Study with Long-Term Follow-Up. Plast Reconstr Surg. 2020 Feb;145(2):358-364. doi: 10.1097/PRS.0000000000006462.
PubMed 31985622Arsiwala SZ, Desai SR. Fractional Carbon Dioxide Laser: Optimizing Treatment Outcomes for Pigmented Atrophic Acne Scars in Skin of Color. J Cutan Aesthet Surg. 2019 Apr-Jun;12(2):85-94. doi: 10.4103/JCAS.JCAS_171_18.
PubMed 31413476Emer J. Platelet-Rich Plasma (PRP): Current Applications in Dermatology. Skin Therapy Lett. 2019 Sep;24(5):1-6.
PubMed 31584784Mu YZ, Jiang L, Yang H. The efficacy of fractional ablative carbon dioxide laser combined with other therapies in acne scars. Dermatol Ther. 2019 Nov;32(6):e13084. doi: 10.1111/dth.13084. Epub 2019 Oct 7.
PubMed 31496020Tanizaki H, Tanioka M, Yamashita Y, Hayashi N. Quantitative evaluation of atrophic acne scars using 3D image analysis with reflected LED light. Skin Res Technol. 2020 Jan;26(1):20-24. doi: 10.1111/srt.12756. Epub 2019 Sep 2.
PubMed 31478266Petit L, Zugaj D, Bettoli V, Dreno B, Kang S, Tan J, Torres V, Layton AM, Martel P. Validation of 3D skin imaging for objective repeatable quantification of severity of atrophic acne scarring. Skin Res Technol. 2018 Nov;24(4):542-550. doi: 10.1111/srt.12464. Epub 2018 Mar 6.
PubMed 29512189
Study at a glance
From the registry record, last updated by the sponsor on 3 Jun 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Single-Blinded Split Face Prospective Study Comparing Different Energy, Efficacy, and Safety of UltraPulse CO2 Laser in the Treatment of Acne Scar Using Antera Quantitative 3D Image Analysis
- ClinicalTrials.gov ID
- NCT04648995
- Acronym / sponsor ID
- N202007052
- Conditions
- Acne Scar
- Keywords
- UltraPulse CO2 Laser, Antera Quantitative 3D Image, Collagen, Elastic fiber, Scale for global severity of facial acne scar
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 20 participants (estimated)
- Lead sponsor
- Haute Beauté Skin & Vein ClinicUniversity, hospital or other
- Collaborators
- Lumenis Be Ltd., Taipei Medical University Shuang Ho Hospital
- Study start
- 11 Dec 2020 (actual)
- Primary completion
- 8 Sep 2021 (estimated)
- Study completion
- 28 Nov 2021 (estimated)
- First posted
- 2 Dec 2020 (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.
Purpose of the study is to assess the effect and evaluate topographic volume changes of UltraPulse at treating boxcar scars with different energy and the effect of UltraPulse at treating icepick scars.
Detailed description
After being informed about the study and potential risks, all patients giving written informed consent will undergo a 24 hour screening period to determine eligibility for study entry. Upon enrollment, patient who fulfill all the inclusion criteria and does not fulfill any exclusion criteria will be scheduled for their visits.
All subjects will be receiving two sessions of treatment, with the two sessions 8-12 weeks apart. Subjects' face will be divided to left and right, with each side randomized to receive a low versus high energy setting. In the low energy setting side of the face, central base of boxcar scar will be treated with 20mJ, while shoulder of scar will be treated with 50 mJ. In the high energy setting side of the face, central base of boxcar scar will be treated with 30mJ, while shoulder of scar will be treated with 60 mJ. Subject will be blinded regarding which side of the face received low versus high energy setting.
Ultrasound will be used to assess epidermal and dermal thickness change at the treated area. This will be performed before the 1st and 2nd treatment session as well as one month and three month after the 2nd treatment session.
Antera Quantitative 3D Image Analysis will be performed before and after the 1st and 2nd treatment session as well as one month and three month after the 2nd treatment session.
3mm punch biopsy will be taken from 10 volunteers over bilateral face before the 1st treatment session and 3 month after the 2nd treatment session (total of 4 sample will be obtained in each volunteer). Skin specimen will be stained with hematoxylin and eosin as well as relevant stain for collagen and elastic fiber.
Clinical photograph will be taken before and after the 1st and 2nd treatment session as well as one month and three month after the 2nd treatment session. Two blinded board certified dermatologist will be asked to rate the improvement of acne scar by GSAAS according to the clinical photograph taken.
All subjects will be asked to rate their satisfaction regarding treatment response over each side of the face using a 0 to 10 point scale chart.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
- Model description
- Low energy: Half of the face that receives low energy, their central base of boxcar scar will be treated with 20mJ, while shoulder of scar will be treated with 50 mJ High energy: Half of the face that receives low energy, their central base of boxcar scar will be treated with 30mJ, while shoulder of scar will be treated with 60 mJ
| Arm | Type | Receives |
|---|---|---|
| High energy | Other | Device: High energy (UltraPulse)Half of the face that receives low energy, their central base of boxcar scar will be treated with 30mJ, while shoulder of scar will be treated with 60 mJ |
| Low energy | Other | Device: Low energy (UltraPulse)Half of the face that receives low energy, their central base of boxcar scar will be treated with 20mJ, while shoulder of scar will be treated with 50 mJ |
Who may qualify
- Ages
- 20 to 60 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (6 listed)
- Subjects have to be aged from 20 to 60 year-old
- Subjects currently have an area of involvement approximately 2cm × 2cm on each side of the face over the temples or cheek bone area
- Classified as mild to moderate acne scar according to global severity of facial acne scar (GSAAS) score
- After evaluation by clinician, those subjects to be treated with "Lumenis"CO2 Laser System (UltraPulse) can benefit from this laser treatment
- Subjects need to be fully functional and aware of the pros and cons of the study. Subject is capable to make self judgement and sign the inform consent under his/her own will
Key exclusion criteria (17 listed)
- Those who were known to have keloid formation
- Those who have porphyria or known photosensitivity
- Those who previously underwent laser therapy treatment or skin biopsy and have showed poor result or adverse effect
- Those who were classified as "severe" according to GSAAS system
- Those who have bleeding tendency
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 |
|---|---|---|
| High energy (UltraPulse)Half of the face that receives low energy, their central base of boxcar scar will be treated with 30mJ, while shoulder of scar will be treated with 60 mJ | Device | High energy |
| Low energy (UltraPulse)Half of the face that receives low energy, their central base of boxcar scar will be treated with 20mJ, while shoulder of scar will be treated with 50 mJ | Device | Low energy |
Primary outcome
Topographic volume changes of acne scars from baseline one month and three month after the 2nd treatment session
Time frame: from baseline one month and three month after the 2nd treatment session
Topographic volume changes of acne scars from baseline one month and three month after the 2nd treatment session
Histological change in epidermal/dermal component including elastic fiber and collagen synthesis three month after the 2nd treatment session from baseline
Time frame: three month after the 2nd treatment session from baseline
Histological change in epidermal/dermal component including elastic fiber and collagen synthesis three month after the 2nd treatment session from baseline
5 secondary outcomes
Access improvement of acne scar by Scale for global severity of facial acne scar from baseline one month and three month after the 2nd treatment session in both the low and high energy treated arm
Time frame: from baseline one month and three month after the 2nd treatment session
Compare the difference of improvement of acne scar by Scale for global severity of facial acne scar in the low versus high energy treated arm
Time frame: from baseline and three month after the 2nd treatment session
Compare the difference of newly synthesis collagen and elastic fiber through staining in the low versus high energy treated arm
Time frame: from baseline and three month after the 2nd treatment session
Assess the frequency and severity of encountered side effects in the low versus high energy treated arm
Time frame: from baseline and three month after the 2nd treatment session
Subjects' satisfaction score rated in a 0 to 10 point scale
Time frame: after the 2nd treatment session、one month and three month after the 2nd treatment session
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Jun 2021.
- Background: PubMed 25296739Dreno B, Thiboutot D, Layton AM, Berson D, Perez M, Kang S; Global Alliance to Improve Outcomes in Acne. Large-scale international study enhances understanding of an emerging acne population: adult females. J Eur Acad Dermatol Venereol. 2015 Jun;29(6):1096-106. doi: 10.1111/jdv.12757. Epub 2014 Oct 8.
- Background: PubMed 31531167Bhargava S, Kumar U, Varma K. Subcision and Microneedling as an Inexpensive and Safe Combination to Treat Atrophic Acne Scars in Dark Skin: A Prospective Study of 45 Patients at a Tertiary Care Center. J Clin Aesthet Dermatol. 2019 Aug;12(8):18-22. Epub 2019 Aug 1.
- Background: PubMed 11423843Jacob CI, Dover JS, Kaminer MS. Acne scarring: a classification system and review of treatment options. J Am Acad Dermatol. 2001 Jul;45(1):109-17. doi: 10.1067/mjd.2001.113451.
- Background: PubMed 31985622Alster TS, Li MKY. Microneedling of Scars: A Large Prospective Study with Long-Term Follow-Up. Plast Reconstr Surg. 2020 Feb;145(2):358-364. doi: 10.1097/PRS.0000000000006462.
- Background: PubMed 31413476Arsiwala SZ, Desai SR. Fractional Carbon Dioxide Laser: Optimizing Treatment Outcomes for Pigmented Atrophic Acne Scars in Skin of Color. J Cutan Aesthet Surg. 2019 Apr-Jun;12(2):85-94. doi: 10.4103/JCAS.JCAS_171_18.
- Background: PubMed 31584784Emer J. Platelet-Rich Plasma (PRP): Current Applications in Dermatology. Skin Therapy Lett. 2019 Sep;24(5):1-6.
- Background: PubMed 31496020Mu YZ, Jiang L, Yang H. The efficacy of fractional ablative carbon dioxide laser combined with other therapies in acne scars. Dermatol Ther. 2019 Nov;32(6):e13084. doi: 10.1111/dth.13084. Epub 2019 Oct 7.
- Background: PubMed 31478266Tanizaki H, Tanioka M, Yamashita Y, Hayashi N. Quantitative evaluation of atrophic acne scars using 3D image analysis with reflected LED light. Skin Res Technol. 2020 Jan;26(1):20-24. doi: 10.1111/srt.12756. Epub 2019 Sep 2.
- Background: PubMed 29512189Petit L, Zugaj D, Bettoli V, Dreno B, Kang S, Tan J, Torres V, Layton AM, Martel P. Validation of 3D skin imaging for objective repeatable quantification of severity of atrophic acne scarring. Skin Res Technol. 2018 Nov;24(4):542-550. doi: 10.1111/srt.12464. Epub 2018 Mar 6.
- Individual participant dataSharing planned: No
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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.
Kuo-Liang Cheng, MD principal investigator
Haute Beauté Skin & Vein Clinic
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing High energy (UltraPulse) and Low energy (UltraPulse) in people with Acne Scar, run by Haute Beauté Skin & Vein Clinic at 1 site in Taiwan.
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 17 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: status not confirmed, as of the sponsor's last update on 3 Jun 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 Taiwan. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Kuo-Liang Cheng, MD (+886-28787-2112, dermacarl@hotmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Topographic volume changes of acne scars from baseline one month and three month after the 2nd treatment session (time frame: from baseline one month and three month after the 2nd treatment session). The study lists 2 primary outcomes in all. 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 NCT04648995, which also lists 9 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 3 Jun 2021.