Post-inflammatory HyperpigmentationNCT05495503
Tolerance of Cyto-selective Difluoroethane-based Cryotherapy in the Treatment of Post-inflamamatory Hyperpigmentation (PIH).
A study testing Prototype (814A-v1), Prototype (814B-v1) and Prototype (814C-v1) in people with Post-inflammatory Hyperpigmentation, run by Cryonove Pharma at 1 site in South Africa.
Trial summary
CS5_2 study aims to evaluate the tolerance of 4 different conditions of cryotherapy treatments applied on dorsal post-inflammatory hyperpigmentation (PIH) spots. This study is a proof of concept, designed to be interventional, monocentric, randomized and double blind. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Post-inflammatory Hyperpigmentation
- What is being tested?
- Prototype (814A-v1), Prototype (814B-v1) and Prototype (814C-v1)
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 12 participants
- Where
- 1 siteSouth Africa
- Study dates
- 18 Oct 2022to 14 Dec 2022
- 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 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Female or male.
- African ethnicity
- Ages 18 to 65.
- Phototype V and VI according to Fitzpatrick scale
- Featuring brown spots (PIH) on the back ≥ 3 mm to ≤ 6 mm in diameter (at least 4 spots per subject).
- Agreeing not to be exposed to the sun (or artificial UV) during the study.
Show all 9Show fewer
- Informed, having undergone a general clinical examination attesting to his ability to participate in the study.
- Having given written consent for participation in the study.
- No suspicion of carcinoma after investigation by a Dermatologist.
Who cannot join
- Having performed cosmetic treatments (exfoliants, scrubs or self-tanners, UV ...) in the month before the start of the study, at the level of the back.
- Having applied a depilatory or exfoliating product in the month prior to the start of the study, at the level of the back.
- Having performed cosmetic treatments in a dermatologist (laser, Intense Pulsed Light (IPL), peeling, creams, cryotherapy ...), at the level of the back in the last 6 months.
- With dermatosis, autoimmune disease, systemic, chronic or acute disease, or any other pathology that may interfere with treatment or influence the results of the study (people with diabetes or circulatory problems, allergic to cold, Raynaud's syndrome...).
- Receiving treatment by general or local (dermo corticoids, corticosteroids, diuretics, anti-coagulants ...) likely to interfere with the evaluation of the parameter studied.
- Participating in another study or being excluded from a previous study.
Show all 17Show fewer
- Unable to follow the requirements of the protocol.
- Vulnerable: whose ability or freedom to give or refuse consent is limited.
- Major protected by law (tutorship, curatorship, safeguarding justice...).
- People unable to read and write English language.
- Unable to be contacted urgently over the phone.
- Been on any other medication which may affect the outcome of the study or affect the skin condition in some way.
- Having ever undergone chemotherapy or other radiation treatment or received any prescription medication or medical treatment understood by them to affect the skin condition.
- Having any skin condition otherwise unsuitable for treatment in the opinion of the Investigator or clinician.
- For female subjects:
- Pregnant woman (or wishing to be pregnant during study) or while breastfeeding.
- A woman, who does not use effective methods of contraception.
Trial locations and contacts
1 site in 1 country.
South Africa1 site
Photobiology Laboratory, Sefako Makgatho Health Sciences University
Pretoria, Gauteng, 0204
About this study
Official title: Evaluation of the Tolerance of Cyto-selective Difluoroethane-based Cryotherapy in the Treatment of Post-inflamamatory Hyperpigmentation (PIH).
CS5_2 study aims to evaluate the tolerance of 4 different conditions of cryotherapy treatments applied on dorsal post-inflammatory hyperpigmentation (PIH) spots.
This study is a proof of concept, designed to be interventional, monocentric, randomized and double blind.
The study will evaluate 4 prototypes : (814A-v1), (814B-v1), (814C-v1) and (814D-v1).
Read the detailed description
Background:
Hyperpigmentation is a problem in all skin types. Safe depigmentation is a challenge. Cryotherapy with liquid nitrogen at -70 °C has been used in the treatment of solar skin lesions for many years but causes considerable damage.
Difluoroethane sprays (CRYONOVE) induce skin temperatures from -5 to -15 °C which ablates melanocytes but leaves the other skin cells viable, causing less discomfort and damage. The prototype sprays in this proof of concept study have been proven safe and effective in the treatment of hyperpigmentation (solar lentigines) in Fitzpatrick skin types (FST) I to IV. Although lentigines are uncommon in darker phototypes, hyperpigmentation (PIH and melasma) is a major issue, thus this study seeks to assess the tolerance (acceptability) of the approach in hyperpigmented unexposed dorsal skin.
Following the side effects occurring after conventional cryotherapy application, the sponsor has selected other sequences of a specific cryogenic spray which has been used effectively and safely for lentigos treatment in Fitzpatrick Phototypes I to IV, with benefit for the consumers without any adverse safety outcomes. There is therefore a need to test the devices on darker skin types (Fitzpatrick V and VI), which also encounter hyperpigmentation challenges.
Design:
In this proof of concept study, the sponsor aims to evaluate the tolerance of 4 prototypes of cryogenic spray.
Intervention:
The prototypes are (814A-v1), (814B-v1), (814C-v1) and (814D-v1) and will be applied on PIH located on the dorsal area. Each treatment corresponds to a specific sequence of a cryogenic spray.
12 subjects will be includes to reach at least 48 brown spots treated. The PIH spots must be between ≥ 3 mm to ≤ 6 mm in diameter.
Each spot will be treated by one of a defined prototype (always the same prototype on the same spot all along the study) and will be treated twice during the study with a 15-day interval between each treatment. At D0, D14 for all the prototypes (814A-v1), (814B-v1), (814C-v1) and (814D-v1).
The follow up visits will be programmed at D7, D21, D28 and D56 for the end visit.
In total this study extends over 8 weeks and involves seven visits (D<0 (inclusion visit), D0,D7, D14, D21, D28 and D56).
Prior to any study device application, the dermatologist will assess the adverse events and will decide if the period between the two applications should be extended or not. The dermatologist will verify that the skin has not been treated by cosmetic products (no presence of cream that could interfere with the treatment) and is dry.
An operator previously trained by the dermatologist will apply the study device to the patient's spots.
Subjects will be lying on their abdomen to make application more stable, and the treatment will be administered with device.
- Conditions
- Post-inflammatory Hyperpigmentation
- Being tested
- Prototype (814A-v1), Prototype (814B-v1), Prototype (814C-v1), Prototype (814D-v1)
- Keywords
- Cryotherapy, Hyperpigmentation, Skin Diseases
- Medical subject headings
- Hyperpigmentation, Skin Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Prototype (814A-v1)Device
Application on PIH located on the dorsal area (2 treatments during the study).
Prototype (814B-v1)Device
Application on PIH located on the dorsal area (2 treatments during the study).
Prototype (814C-v1)Device
Application on PIH located on the dorsal area (2 treatments during the study).
Prototype (814D-v1)Device
Application on PIH located on the dorsal area (2 treatments during the study).
| Study group | Role | What they receive |
|---|---|---|
| Prototype (814A-v1) | Experimental | Application of the prototype (814A-v1) at D0 and D7. Receives: Device: Prototype (814A-v1) |
| Prototype (814B-v1) | Experimental | Application of the prototype (814B-v1) at D0 and D7. Receives: Device: Prototype (814B-v1) |
| Prototype (814C-v1) | Experimental | Application of the prototype (814C-v1) at D0 and D7. Receives: Device: Prototype (814C-v1) |
| Prototype (814D-v1) | Experimental | Application of the prototype (814D-v1) at D0 and D7. Receives: Device: Prototype (814D-v1) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change from baseline skin hyperpigmentation
Clinical evaluation of outcomes on each selected and treated spot will be performed by a Dermatologist by scoring with standardized position and lighting at each visit and before each treatment.
The evaluation will be performed visually on the selected spots. A scale in 6 points (0 to 5) will be used : 0=Clear of hyperpigmentation; 1= Almost clear of hyperpigmentation; 2=mild, but noticeable hyperpigmentation; 3=moderate hyperpigmentation (medium brown in quality); 4=severe hyperpigmentation (dark brown in quality); 5= very severe hyperpigmentation (very dark brown, almost black in quality).
Measured: Day 0, Day 7, Day 14, Day 21, Day 28 and Day 56
Change from baseline skin hypopigmentation
Clinical evaluation of outcomes on each selected and treated spot will be performed by a Dermatologist by scoring with standardized position and lighting at each visit and before each treatment.
The evaluation will be performed visually on the selected spots. A scale in 5 points will be used (0 to 4): 0=no hypopigmented lesion; 1= very slight area of hypopigmentation of very small size and very slightly fairer than the surrounding skin; 2= slight area of hypopigmentation of small size and slightly fairer than the surrounding skin; 3= moderate : area of hypopigmentation of moderate size and much fairer than the surrounding skin; 4= severe : area of hypopigmentation of large size and much fairer than the surrounding skin
Measured: Day 0, Day 7, Day 14, Day 21, Day 28 and Day 56
Change from baseline skin appearance
Clinical evaluation of outcomes on each selected and treated spot will be performed by a Dermatologist by scoring with standardized position and lighting at each visit and before each treatment.
The evaluation will be performed visually on the selected spots and surrounded spotless skin area around the spot skin to assess erythema, oedema blister, bubble, scars, micro-bruise, hematoma, dryness,desquamation, fissures/cracks, roughness,crust.
A scale in 5 points (0 to 4) will be used : 0=none; 1=very mild; 2=mild; 3=moderate; 4=severe.
Measured: Day 0, Day 7, Day 14, Day 21, Day 28 and Day 56
Change from baseline skin sensation
Clinical evaluation of outcomes on each selected and treated spot will be performed by a Dermatologist by scoring with standardized position and lighting at each visit and before each treatment.
The evaluation will be performed visually on the selected spots and around the spot skin to assess tightness, stinging, itching, warm and burning sensation.
A scale in 5 points (0 to 4) will be used : 0=none; 1=very mild; 2=mild; 3=moderate; 4=severe.
Measured: Day 0, Day 7, Day 14, Day 21, Day 28 and Day 56
Self-assesment of pain
The pain of the treatment will be assessed by the Visual Analogue Scale (VAS) at time T0 on the treated area.
The pain assessed is that felt during the application of the devices. It will be collected from the patient within 5 minutes of application.
The VAS is made up of a 10-centimeter line anchored by two ends of the pain. One end is the "maximum pain imaginable". The other end is "no pain."
Measured: Day 0
Change from baseline spots visibility
Standardized photographs will be taken using a Dermatoscope C-Cube® (PIXIENCE). The capture will be taken on the previously selected spot (and spotless surrounding each spot in the same acquisition) and a spotless area (one on back and far from PIH spot).
Acquisition will be performed at Day0/time 0 (before treatment) and at each visit.
Measured: Day 0, Day 7, Day 14, Day 21, Day 28 and Day 56
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Aug 2022
- Study start18 Oct 2022
- Primary completion14 Dec 2022
- Study completion14 Dec 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Post-inflammatory HyperpigmentationStudies 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
- Sequential
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 12 participants (actual)
Sponsor and investigators
- Lead sponsor
- Cryonove Pharma
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Dermatech, CEISO
- Responsible party
- Sponsor
- Investigators
- Beverley Summers, Principal investigator, beverley.summers@smu.ac.za
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05495503
- Sponsor's protocol ID
- CS5_2
- Status last verified
- Jun 2023
- First submitted
- 4 Aug 2022
- Last updated
- 26 Jun 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 26 Jun 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of the Tolerance of Cyto-selective Difluoroethane-based Cryotherapy in the Treatment of Post-inflamamatory Hyperpigmentation (PIH).
- ClinicalTrials.gov ID
- NCT05495503
- Acronym / sponsor ID
- CS5_2
- Conditions
- Post-inflammatory Hyperpigmentation
- Keywords
- Cryotherapy, Hyperpigmentation, Skin Diseases
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 12 participants (actual)
- Lead sponsor
- Cryonove PharmaIndustry (pharma, biotech, devices)
- Collaborators
- Dermatech, CEISO
- Study start
- 18 Oct 2022 (actual)
- Primary completion
- 14 Dec 2022 (actual)
- Study completion
- 14 Dec 2022 (actual)
- First posted
- 10 Aug 2022 (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.
CS5_2 study aims to evaluate the tolerance of 4 different conditions of cryotherapy treatments applied on dorsal post-inflammatory hyperpigmentation (PIH) spots.
This study is a proof of concept, designed to be interventional, monocentric, randomized and double blind.
The study will evaluate 4 prototypes : (814A-v1), (814B-v1), (814C-v1) and (814D-v1).
Detailed description
Background:
Hyperpigmentation is a problem in all skin types. Safe depigmentation is a challenge. Cryotherapy with liquid nitrogen at -70 °C has been used in the treatment of solar skin lesions for many years but causes considerable damage.
Difluoroethane sprays (CRYONOVE) induce skin temperatures from -5 to -15 °C which ablates melanocytes but leaves the other skin cells viable, causing less discomfort and damage. The prototype sprays in this proof of concept study have been proven safe and effective in the treatment of hyperpigmentation (solar lentigines) in Fitzpatrick skin types (FST) I to IV. Although lentigines are uncommon in darker phototypes, hyperpigmentation (PIH and melasma) is a major issue, thus this study seeks to assess the tolerance (acceptability) of the approach in hyperpigmented unexposed dorsal skin.
Following the side effects occurring after conventional cryotherapy application, the sponsor has selected other sequences of a specific cryogenic spray which has been used effectively and safely for lentigos treatment in Fitzpatrick Phototypes I to IV, with benefit for the consumers without any adverse safety outcomes. There is therefore a need to test the devices on darker skin types (Fitzpatrick V and VI), which also encounter hyperpigmentation challenges.
Design:
In this proof of concept study, the sponsor aims to evaluate the tolerance of 4 prototypes of cryogenic spray.
Intervention:
The prototypes are (814A-v1), (814B-v1), (814C-v1) and (814D-v1) and will be applied on PIH located on the dorsal area. Each treatment corresponds to a specific sequence of a cryogenic spray.
12 subjects will be includes to reach at least 48 brown spots treated. The PIH spots must be between ≥ 3 mm to ≤ 6 mm in diameter.
Each spot will be treated by one of a defined prototype (always the same prototype on the same spot all along the study) and will be treated twice during the study with a 15-day interval between each treatment. At D0, D14 for all the prototypes (814A-v1), (814B-v1), (814C-v1) and (814D-v1).
The follow up visits will be programmed at D7, D21, D28 and D56 for the end visit.
In total this study extends over 8 weeks and involves seven visits (D<0 (inclusion visit), D0,D7, D14, D21, D28 and D56).
Prior to any study device application, the dermatologist will assess the adverse events and will decide if the period between the two applications should be extended or not. The dermatologist will verify that the skin has not been treated by cosmetic products (no presence of cream that could interfere with the treatment) and is dry.
An operator previously trained by the dermatologist will apply the study device to the patient's spots.
Subjects will be lying on their abdomen to make application more stable, and the treatment will be administered with device.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Sequential
- Masking
- Double blind (participant, investigator)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Prototype (814A-v1) | Experimental | Device: Prototype (814A-v1)Application of the prototype (814A-v1) at D0 and D7. |
| Prototype (814B-v1) | Experimental | Device: Prototype (814B-v1)Application of the prototype (814B-v1) at D0 and D7. |
| Prototype (814C-v1) | Experimental | Device: Prototype (814C-v1)Application of the prototype (814C-v1) at D0 and D7. |
| Prototype (814D-v1) | Experimental | Device: Prototype (814D-v1)Application of the prototype (814D-v1) at D0 and D7. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- Female or male.
- African ethnicity
- Ages 18 to 65.
- Phototype V and VI according to Fitzpatrick scale
- Featuring brown spots (PIH) on the back ≥ 3 mm to ≤ 6 mm in diameter (at least 4 spots per subject).
Key exclusion criteria (17 listed)
- Having performed cosmetic treatments (exfoliants, scrubs or self-tanners, UV ...) in the month before the start of the study, at the level of the back.
- Having applied a depilatory or exfoliating product in the month prior to the start of the study, at the level of the back.
- Having performed cosmetic treatments in a dermatologist (laser, Intense Pulsed Light (IPL), peeling, creams, cryotherapy ...), at the level of the back in the last 6 months.
- With dermatosis, autoimmune disease, systemic, chronic or acute disease, or any other pathology that may interfere with treatment or influence the results of the study (people with diabetes or circulatory problems, allergic to cold, Raynaud's syndrome...).
- Receiving treatment by general or local (dermo corticoids, corticosteroids, diuretics, anti-coagulants ...) likely to interfere with the evaluation of the parameter studied.
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 |
|---|---|---|
| Prototype (814A-v1)Application on PIH located on the dorsal area (2 treatments during the study). | Device | Prototype (814A-v1) |
| Prototype (814B-v1)Application on PIH located on the dorsal area (2 treatments during the study). | Device | Prototype (814B-v1) |
| Prototype (814C-v1)Application on PIH located on the dorsal area (2 treatments during the study). | Device | Prototype (814C-v1) |
| Prototype (814D-v1)Application on PIH located on the dorsal area (2 treatments during the study). | Device | Prototype (814D-v1) |
Primary outcome
Change from baseline skin hyperpigmentation
Time frame: Day 0, Day 7, Day 14, Day 21, Day 28 and Day 56
Clinical evaluation of outcomes on each selected and treated spot will be performed by a Dermatologist by scoring with standardized position and lighting at each visit and before each treatment. The evaluation will be performed visually on the selected spots. A scale in 6 points (0 to 5) will be used : 0=Clear of hyperpigmentation; 1= Almost clear of hyperpigmentation; 2=mild, but noticeable hyperpigmentation; 3=moderate hyperpigmentation (medium brown in quality); 4=severe hyperpigmentation (dark brown in quality); 5= very severe hyperpigmentation (very dark brown, almost black in quality).
Change from baseline skin hypopigmentation
Time frame: Day 0, Day 7, Day 14, Day 21, Day 28 and Day 56
Clinical evaluation of outcomes on each selected and treated spot will be performed by a Dermatologist by scoring with standardized position and lighting at each visit and before each treatment. The evaluation will be performed visually on the selected spots. A scale in 5 points will be used (0 to 4): 0=no hypopigmented lesion; 1= very slight area of hypopigmentation of very small size and very slightly fairer than the surrounding skin; 2= slight area of hypopigmentation of small size and slightly fairer than the surrounding skin; 3= moderate : area of hypopigmentation of moderate size and much fairer than the surrounding skin; 4= severe : area of hypopigmentation of large size and much fairer than the surrounding skin
Change from baseline skin appearance
Time frame: Day 0, Day 7, Day 14, Day 21, Day 28 and Day 56
Clinical evaluation of outcomes on each selected and treated spot will be performed by a Dermatologist by scoring with standardized position and lighting at each visit and before each treatment. The evaluation will be performed visually on the selected spots and surrounded spotless skin area around the spot skin to assess erythema, oedema blister, bubble, scars, micro-bruise, hematoma, dryness,desquamation, fissures/cracks, roughness,crust. A scale in 5 points (0 to 4) will be used : 0=none; 1=very mild; 2=mild; 3=moderate; 4=severe.
Change from baseline skin sensation
Time frame: Day 0, Day 7, Day 14, Day 21, Day 28 and Day 56
Clinical evaluation of outcomes on each selected and treated spot will be performed by a Dermatologist by scoring with standardized position and lighting at each visit and before each treatment. The evaluation will be performed visually on the selected spots and around the spot skin to assess tightness, stinging, itching, warm and burning sensation. A scale in 5 points (0 to 4) will be used : 0=none; 1=very mild; 2=mild; 3=moderate; 4=severe.
Self-assesment of pain
Time frame: Day 0
The pain of the treatment will be assessed by the Visual Analogue Scale (VAS) at time T0 on the treated area. The pain assessed is that felt during the application of the devices. It will be collected from the patient within 5 minutes of application. The VAS is made up of a 10-centimeter line anchored by two ends of the pain. One end is the "maximum pain imaginable". The other end is "no pain."
Change from baseline spots visibility
Time frame: Day 0, Day 7, Day 14, Day 21, Day 28 and Day 56
Standardized photographs will be taken using a Dermatoscope C-Cube® (PIXIENCE). The capture will be taken on the previously selected spot (and spotless surrounding each spot in the same acquisition) and a spotless area (one on back and far from PIH spot). Acquisition will be performed at Day0/time 0 (before treatment) and at each visit.
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 26 Jun 2023.
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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.
Beverley Summers principal investigator
beverley.summers@smu.ac.za
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Prototype (814A-v1), Prototype (814B-v1) and Prototype (814C-v1) in people with Post-inflammatory Hyperpigmentation, run by Cryonove Pharma at 1 site in South Africa.
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 9 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: finished, as of the sponsor's last update on 26 Jun 2023. 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 South Africa. 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?
Change from baseline skin hyperpigmentation (time frame: Day 0, Day 7, Day 14, Day 21, Day 28 and Day 56). The study lists 6 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 26 Jun 2023.