BurnsNCT04277182
Effect of Propolis Application on Burn Healing
A study testing burn wound dressing in people with Burns and Burn Wound, run by Izmir Katip Celebi University at 1 site in Turkey (Türkiye).
Trial summary
This experimental study will be carried out at Ege University Laboratory Animals Application and Research Center to identify the efficacy of 10% propolis and 15% propolis on wound healing in a second-degree superficial burn wound. Read more about this study
- Who is it for?
- Ages 8 to 12 weeksHealthy volunteers can take part
- Conditions the study is for
- Burns, Burn Wound
- What is being tested?
- burn wound dressing
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 36 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 1 Sep 2020to 28 Sep 2020
- 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 8 to 12 weeks
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- adult (8-12 weeks)
- 200-300 grams
- Wistar-Albino rat
- with 4 second-degree superficial contact burn are at its back.
Who cannot join
- the death of the rat in the research process
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Effect of Topical Turkish Propolis Application on Burn Healing in Experimental Burn Model
This experimental study will be carried out at Ege University Laboratory Animals Application and Research Center to identify the efficacy of 10% propolis and 15% propolis on wound healing in a second-degree superficial burn wound.
In the study, 36 adult (8-12 week old) Wistar-Albino rats with a weight of 200-300 grams will be used in each group. Each group will include 6 rats. Stratified randomization will be used to randomize rats according to their gender and weight. After randomization, a burnt area will be created on the back of the rats and dressings will be made every day.
Read more
Following the creation of the burn, biopsy samples will be taken on the 3rd, 7th, 14th and 21st days and at the light microscopic level; bulla, erythema, oedema, burn depth, inflammatory cell infiltration, necrosis, ulceration, angiogenesis, neovascularization, fibroblast proliferation, collagenization, epithelization, fibrosis, the number of hair follicles and damage to the skin attachments.
In the immunohistochemical examination of biopsy samples, samples will be taken for the evaluation of superoxide dismutase, malondialdehyde, myeloperoxidase in the evaluation of the tumour necrosis factor-alpha, interleukin-1β and oxidative stress in the EBB period in order to evaluate the acute phase reactants. Fungal and gram staining will be done in order to determine the pathogen reproduction in biopsy samples taken on the 3rd and 7th day. Masson trichrome in order to detect fibrosis in biopsy samples taken on the 14th and 21st day; Hydroxyproline examination will be examined in order to evaluate collagen formation.
- Conditions
- Burns, Burn Wound
- Being tested
- burn wound dressing
- Keywords
- Burn, Burn wound, Propolis, Wound healing
- Medical subject headings
- Burns
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
burn wound dressingBiological
- st. group: It will be considered as a control group and rats will not be treated.
- nd. group: Vehicle group, Propolis vehicle will be applied topically to rats for 21 days.
- rd group: Silver Sulfadiazine group, 1% Silver Sulfadiazine will be applied topically to rats for 21 days.
- th. group: Nitrafurozon group, 0.2% Nitrafurozon will be applied topically for 21 days.
- th. group: 10% Propolis group, 10% Propolis will be applied topically for 21 days.
- th. group: 15% Propolis group, 15% Propolis will be applied topically for 21 days.
| Study group | Role | What they receive |
|---|---|---|
| Control group | Placebo comparator | It will be accepted as the control group and 4 experimental burn wounds will be created on the back of the rats in the group and no treatment will be given. Receives: Biological: burn wound dressing |
| 1% Silver Sulfadiazine | Active comparator | 4 experimental burn wounds will be created on the back of the rats in the group and dressing with 1% Silver Sulfadiazine will be done on the back of the rats every day for 21 days. Receives: Biological: burn wound dressing |
| %0.2 Nitrafurozon | Active comparator | 4 experimental burn wounds will be created on the back of the rats in the group and dressing with %0.2 Nitrafurozon will be done on the back of the rats every day for 21 days. Receives: Biological: burn wound dressing |
| 10% Propolis | Experimental | 4 experimental burn wounds will be created on the back of the rats in the group and dressing with 10% Propolis will be done on the back of the rats every day for 21 days. Receives: Biological: burn wound dressing |
| 15% Propolis | Experimental | 4 experimental burn wounds will be created on the back of the rats in the group and dressing with 15% Propolis will be done on the back of the rats every day for 21 days. Receives: Biological: burn wound dressing |
| Propolis vehicle | Active comparator | 4 experimental burn wounds will be created on the back of the rats in the group and dressing with Propolis vehicle will be done on the back of the rats every day for 21 days. Receives: Biological: burn wound dressing |
What is being measured
The primary outcome is the main question the study is designed to answer.
wound size
photos will be taken every day to determine the wound size
Measured: 21 days
bulla
examination of the skin at the light microscopic level. Bulla will be considered as present or absent.
Measured: 3rd day of the research
bulla
examination of the skin at the light microscopic level. Bulla will be considered as present or absent.
Measured: 7th day of the research
bulla
examination of the skin at the light microscopic level. Bulla will be considered as present or absent.
Measured: 14th day of the research
bulla
examination of the skin at the light microscopic level. Erythemawill be considered as present or absent.
Measured: 21st day day of the research
edema
examination of the skin at the light microscopic level. Edema will be considered as present or absent.
Measured: 3rd day of the research
edema
examination of the skin at the light microscopic level. Edema will be considered as present or absent.
Measured: 7th day of the research
edema
examination of the skin at the light microscopic level. Edema will be considered as present or absent.
Measured: 14th day of the research
edema
examination of the skin at the light microscopic level. Edema will be considered as present or absent.
Measured: 21st day of the research
inflammatory cell infiltration
examination of the skin at the light microscopic level. Inflammatory cell infiltration will be considered as present or absent.
Measured: 3rd day of the research
inflammatory cell infiltration
examination of the skin at the light microscopic level. Inflammatory cell infiltration will be considered as present or absent.
Measured: 7th day of the research
inflammatory cell infiltration
examination of the skin at the light microscopic level. Inflammatory cell infiltration will be considered as present or absent.
Measured: 14th day of the research
inflammatory cell infiltration
examination of the skin at the light microscopic level. Inflammatory cell infiltration will be considered as present or absent.
Measured: 21st day of the research
necrosis
examination of the skin at the light microscopic level. Necrosis will be considered as present or absent.
Measured: 3rd day of the research
necrosis
examination of the skin at the light microscopic level. Necrosis will be considered as present or absent.
Measured: 7th day of the research
necrosis
examination of the skin at the light microscopic level. Necrosis will be considered as present or absent.
Measured: 14th day of the research
necrosis
examination of the skin at the light microscopic level. Necrosis will be considered as present or absent.
Measured: 21st day of the research
ulceration
examination of the skin at the light microscopic level. Ulceration will be considered as present or absent.
Measured: 3rd day of the research
ulceration
examination of the skin at the light microscopic level. Ulceration will be considered as present or absent.
Measured: 7th day of the research
ulceration
examination of the skin at the light microscopic level. Ulceration will be considered as present or absent.
Measured: 14th day of the research
ulceration
examination of the skin at the light microscopic level. Ulceration will be considered as present or absent.
Measured: 21st day of the research
angiogenesis
examination of the skin at the light microscopic level. Angiogenesis will be considered as present or absent.
Measured: 3rd day of the research
angiogenesis
examination of the skin at the light microscopic level. Angiogenesis will be considered as present or absent.
Measured: 7th day of the research
angiogenesis
examination of the skin at the light microscopic level. Angiogenesis will be considered as present or absent.
Measured: 14th day of the research
angiogenesis
examination of the skin at the light microscopic level. Angiogenesis will be considered as present or absent.
Measured: 21st day of the research
fibroblast proliferation
examination of the skin at the light microscopic level. Fibroblast proliferation will be considered as present or absent.
Measured: 3rd day of the research
fibroblast proliferation
examination of the skin at the light microscopic level. Fibroblast proliferation will be considered as present or absent.
Measured: 7th day of the research
fibroblast proliferation
examination of the skin at the light microscopic level. Fibroblast proliferation will be considered as present or absent.
Measured: 14th day of the research
fibroblast proliferation
examination of the skin at the light microscopic level. Fibroblast proliferation will be considered as present or absent.
Measured: 21st day of the research
epithelization
examination of the skin at the light microscopic level. Epithelization will be considered as present or absent.
Measured: 3rd day of the research
epithelization
examination of the skin at the light microscopic level. Epithelization will be considered as present or absent.
Measured: 7th day of the research
epithelization
examination of the skin at the light microscopic level. Epithelization will be considered as present or absent.
Measured: 14th day of the research
epithelization
examination of the skin at the light microscopic level. Epithelization will be considered as present or absent.
Measured: 21st day of the research
collagenization
examination of the skin at the light microscopic level. Collagenization will be considered as present or absent.
Measured: 3rd day of the research
collagenization
examination of the skin at the light microscopic level. Collagenization will be considered as present or absent.
Measured: 7th day of the research
collagenization
examination of the skin at the light microscopic level. Collagenization will be considered as present or absent.
Measured: 14th day of the research
collagenization
examination of the skin at the light microscopic level. Collagenization will be considered as present or absent.
Measured: 21st day of the research
microorganism colonization
examination of the skin at the light microscopic level. Colonization will be considered as present or absent.
Measured: 3rd day of the research
microorganism colonization
examination of the skin at the light microscopic level. Colonization will be considered as present or absent.
Measured: 7th day of the research
microorganism colonization
examination of the skin at the light microscopic level. Colonization will be considered as present or absent.
Measured: 14th day of the research
microorganism colonization
examination of the skin at the light microscopic level. Colonization will be considered as present or absent.
Measured: 21st day of the research
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Feb 2020
- Study start1 Sep 2020
- Primary completion28 Sep 2020
- Study completion28 Sep 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for BurnsStudies 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
- * 1st. group: It will be considered as a control group and rats will not be treated. * 2nd. group: Vehicle group, Propolis vehicle will be applied to rats for 21 days. * 3rd. group: Silver Sulfadiazine group, 1% Silver Sulfadiazine will be applied topically to rats for 21 days. * 4th. group: Nitrafurozon group, 0.2% Nitrafurozon will be applied topically for 21 days. * 5th. group: 10% Propolis group, 10% Propolis will be applied topically for 21 days. * 6th. group: 15% Propolis group, 15% Propolis will be applied topically for 21 days.
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 36 participants (actual)
Sponsor and investigators
- Lead sponsor
- Izmir Katip Celebi University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, ESRA ARDAHAN AKGUL, Izmir Katip Celebi University
- Investigators
- Figen Yardımcı, Study director, Ege University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04277182
- Sponsor's protocol ID
- 2019-048
- Status last verified
- Aug 2022
- First submitted
- 17 Feb 2020
- Last updated
- 3 Aug 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: the study's data is planned to be published and shared in a scientific paper
Study at a glance
From the registry record, last updated by the sponsor on 3 Aug 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Topical Turkish Propolis Application on Burn Healing in Experimental Burn Model
- ClinicalTrials.gov ID
- NCT04277182
- Acronym / sponsor ID
- 2019-048
- Conditions
- Burns, Burn Wound
- Keywords
- Burn, Burn wound, Propolis, Wound healing
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 36 participants (actual)
- Lead sponsor
- Izmir Katip Celebi UniversityUniversity, hospital or other
- Study start
- 1 Sep 2020 (actual)
- Primary completion
- 28 Sep 2020 (actual)
- Study completion
- 28 Sep 2020 (actual)
- First posted
- 20 Feb 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.
This experimental study will be carried out at Ege University Laboratory Animals Application and Research Center to identify the efficacy of 10% propolis and 15% propolis on wound healing in a second-degree superficial burn wound.
In the study, 36 adult (8-12 week old) Wistar-Albino rats with a weight of 200-300 grams will be used in each group. Each group will include 6 rats. Stratified randomization will be used to randomize rats according to their gender and weight. After randomization, a burnt area will be created on the back of the rats and dressings will be made every day.
Following the creation of the burn, biopsy samples will be taken on the 3rd, 7th, 14th and 21st days and at the light microscopic level; bulla, erythema, oedema, burn depth, inflammatory cell infiltration, necrosis, ulceration, angiogenesis, neovascularization, fibroblast proliferation, collagenization, epithelization, fibrosis, the number of hair follicles and damage to the skin attachments.
In the immunohistochemical examination of biopsy samples, samples will be taken for the evaluation of superoxide dismutase, malondialdehyde, myeloperoxidase in the evaluation of the tumour necrosis factor-alpha, interleukin-1β and oxidative stress in the EBB period in order to evaluate the acute phase reactants. Fungal and gram staining will be done in order to determine the pathogen reproduction in biopsy samples taken on the 3rd and 7th day. Masson trichrome in order to detect fibrosis in biopsy samples taken on the 14th and 21st day; Hydroxyproline examination will be examined in order to evaluate collagen formation.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 6
- Model description
- * 1st. group: It will be considered as a control group and rats will not be treated. * 2nd. group: Vehicle group, Propolis vehicle will be applied to rats for 21 days. * 3rd. group: Silver Sulfadiazine group, 1% Silver Sulfadiazine will be applied topically to rats for 21 days. * 4th. group: Nitrafurozon group, 0.2% Nitrafurozon will be applied topically for 21 days. * 5th. group: 10% Propolis group, 10% Propolis will be applied topically for 21 days. * 6th. group: 15% Propolis group, 15% Propolis will be applied topically for 21 days.
| Arm | Type | Receives |
|---|---|---|
| Control group | Placebo comparator | Biological: burn wound dressingIt will be accepted as the control group and 4 experimental burn wounds will be created on the back of the rats in the group and no treatment will be given. |
| 1% Silver Sulfadiazine | Active comparator | Biological: burn wound dressing4 experimental burn wounds will be created on the back of the rats in the group and dressing with 1% Silver Sulfadiazine will be done on the back of the rats every day for 21 days. |
| %0.2 Nitrafurozon | Active comparator | Biological: burn wound dressing4 experimental burn wounds will be created on the back of the rats in the group and dressing with %0.2 Nitrafurozon will be done on the back of the rats every day for 21 days. |
| 10% Propolis | Experimental | Biological: burn wound dressing4 experimental burn wounds will be created on the back of the rats in the group and dressing with 10% Propolis will be done on the back of the rats every day for 21 days. |
| 15% Propolis | Experimental | Biological: burn wound dressing4 experimental burn wounds will be created on the back of the rats in the group and dressing with 15% Propolis will be done on the back of the rats every day for 21 days. |
| Propolis vehicle | Active comparator | Biological: burn wound dressing4 experimental burn wounds will be created on the back of the rats in the group and dressing with Propolis vehicle will be done on the back of the rats every day for 21 days. |
Who may qualify
- Ages
- 8 to 12 weeks
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (4 listed)
- adult (8-12 weeks)
- 200-300 grams
- Wistar-Albino rat
- with 4 second-degree superficial contact burn are at its back.
Key exclusion criteria (1 listed)
- the death of the rat in the research process
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 |
|---|---|---|
| burn wound dressing1. st. group: It will be considered as a control group and rats will not be treated. 2. nd. group: Vehicle group, Propolis vehicle will be applied topically to rats for 21 days. 3. rd group: Silver Sulfadiazine group, 1% Silver Sulfadiazine will be applied topically to rats for 21 days. 4. th. group: Nitrafurozon group, 0.2% Nitrafurozon will be applied topically for 21 days. 5. th. group: 10% Propolis group, 10% Propolis will be applied topically for 21 days. 6. th. group: 15% Propolis group, 15% Propolis will be applied topically for 21 days. | Biological | %0.2 Nitrafurozon, 1% Silver Sulfadiazine, 10% Propolis, 15% Propolis, Control group, Propolis vehicle |
Primary outcome
wound size
Time frame: 21 days
photos will be taken every day to determine the wound size
bulla
Time frame: 3rd day of the research
examination of the skin at the light microscopic level. Bulla will be considered as present or absent.
bulla
Time frame: 7th day of the research
examination of the skin at the light microscopic level. Bulla will be considered as present or absent.
bulla
Time frame: 14th day of the research
examination of the skin at the light microscopic level. Bulla will be considered as present or absent.
bulla
Time frame: 21st day day of the research
examination of the skin at the light microscopic level. Erythemawill be considered as present or absent.
edema
Time frame: 3rd day of the research
examination of the skin at the light microscopic level. Edema will be considered as present or absent.
edema
Time frame: 7th day of the research
examination of the skin at the light microscopic level. Edema will be considered as present or absent.
edema
Time frame: 14th day of the research
examination of the skin at the light microscopic level. Edema will be considered as present or absent.
edema
Time frame: 21st day of the research
examination of the skin at the light microscopic level. Edema will be considered as present or absent.
inflammatory cell infiltration
Time frame: 3rd day of the research
examination of the skin at the light microscopic level. Inflammatory cell infiltration will be considered as present or absent.
inflammatory cell infiltration
Time frame: 7th day of the research
examination of the skin at the light microscopic level. Inflammatory cell infiltration will be considered as present or absent.
inflammatory cell infiltration
Time frame: 14th day of the research
examination of the skin at the light microscopic level. Inflammatory cell infiltration will be considered as present or absent.
inflammatory cell infiltration
Time frame: 21st day of the research
examination of the skin at the light microscopic level. Inflammatory cell infiltration will be considered as present or absent.
necrosis
Time frame: 3rd day of the research
examination of the skin at the light microscopic level. Necrosis will be considered as present or absent.
necrosis
Time frame: 7th day of the research
examination of the skin at the light microscopic level. Necrosis will be considered as present or absent.
necrosis
Time frame: 14th day of the research
examination of the skin at the light microscopic level. Necrosis will be considered as present or absent.
necrosis
Time frame: 21st day of the research
examination of the skin at the light microscopic level. Necrosis will be considered as present or absent.
ulceration
Time frame: 3rd day of the research
examination of the skin at the light microscopic level. Ulceration will be considered as present or absent.
ulceration
Time frame: 7th day of the research
examination of the skin at the light microscopic level. Ulceration will be considered as present or absent.
ulceration
Time frame: 14th day of the research
examination of the skin at the light microscopic level. Ulceration will be considered as present or absent.
ulceration
Time frame: 21st day of the research
examination of the skin at the light microscopic level. Ulceration will be considered as present or absent.
angiogenesis
Time frame: 3rd day of the research
examination of the skin at the light microscopic level. Angiogenesis will be considered as present or absent.
angiogenesis
Time frame: 7th day of the research
examination of the skin at the light microscopic level. Angiogenesis will be considered as present or absent.
angiogenesis
Time frame: 14th day of the research
examination of the skin at the light microscopic level. Angiogenesis will be considered as present or absent.
angiogenesis
Time frame: 21st day of the research
examination of the skin at the light microscopic level. Angiogenesis will be considered as present or absent.
fibroblast proliferation
Time frame: 3rd day of the research
examination of the skin at the light microscopic level. Fibroblast proliferation will be considered as present or absent.
fibroblast proliferation
Time frame: 7th day of the research
examination of the skin at the light microscopic level. Fibroblast proliferation will be considered as present or absent.
fibroblast proliferation
Time frame: 14th day of the research
examination of the skin at the light microscopic level. Fibroblast proliferation will be considered as present or absent.
fibroblast proliferation
Time frame: 21st day of the research
examination of the skin at the light microscopic level. Fibroblast proliferation will be considered as present or absent.
epithelization
Time frame: 3rd day of the research
examination of the skin at the light microscopic level. Epithelization will be considered as present or absent.
epithelization
Time frame: 7th day of the research
examination of the skin at the light microscopic level. Epithelization will be considered as present or absent.
epithelization
Time frame: 14th day of the research
examination of the skin at the light microscopic level. Epithelization will be considered as present or absent.
epithelization
Time frame: 21st day of the research
examination of the skin at the light microscopic level. Epithelization will be considered as present or absent.
collagenization
Time frame: 3rd day of the research
examination of the skin at the light microscopic level. Collagenization will be considered as present or absent.
collagenization
Time frame: 7th day of the research
examination of the skin at the light microscopic level. Collagenization will be considered as present or absent.
collagenization
Time frame: 14th day of the research
examination of the skin at the light microscopic level. Collagenization will be considered as present or absent.
collagenization
Time frame: 21st day of the research
examination of the skin at the light microscopic level. Collagenization will be considered as present or absent.
microorganism colonization
Time frame: 3rd day of the research
examination of the skin at the light microscopic level. Colonization will be considered as present or absent.
microorganism colonization
Time frame: 7th day of the research
examination of the skin at the light microscopic level. Colonization will be considered as present or absent.
microorganism colonization
Time frame: 14th day of the research
examination of the skin at the light microscopic level. Colonization will be considered as present or absent.
microorganism colonization
Time frame: 21st day of the research
examination of the skin at the light microscopic level. Colonization will be considered as present or absent.
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 3 Aug 2022.
- Individual participant dataSharing planned: No. the study's data is planned to be published and shared in a scientific paper
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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.
Figen Yardımcı study director
Ege University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing burn wound dressing in people with Burns and Burn Wound, run by Izmir Katip Celebi University at 1 site in Turkey (Türkiye).
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 4 inclusion and 1 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 3 Aug 2022. 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 Turkey (Türkiye). 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.
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?
wound size (time frame: 21 days). The study lists 41 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 3 Aug 2022.