Localized VitiligoNCT05511493
Efficacy of PRP With Er-YAG Laser Versus With Microneedling in Localized Stable Vitiligo
A study testing fractional Erbium-YAG laser and microneedling in people with Localized Vitiligo, run by South Valley University.
Trial summary
The aims of this study are to:- Compare the effect of fractional Erbium: YAG laser assisted delivery of platelet- rich plasma versus microneedling with platelet-rich plasma in the induction of skin repigmentation in localized stable vitiligo patients. Read more about this study
- Who is it for?
- Ages 10 to 60 years
- Conditions the study is for
- Localized Vitiligo
- What is being tested?
- fractional Erbium-YAG laser and microneedling
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- No sites listed yet
- Study dates
- 1 Oct 2022to 1 Dec 2023
- 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 10 to 60 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- 1) Patients of both sexes with stable localized vitiligo: stable patches (should not have any increase or decrease in size or pigmentation for at least 3 months) .
- 2)Age between 10 - 60 years
Who cannot join
- 1)Acute or chronic infections. 2) Koebner phenomenon. 3) Contraindications to PRP injections:
- Patients with blood or platelet abnormalities.
- Patients taking anti-platelet drugs or anticoagulants.
- Patients with a history of altered or abnormal fibroblast function, such as collagen diseases or myelofibrosis.
- 4) We also excluded pregnant or lactating women. 5) All patients included had not received any local or systemic medication for at least 2 months before the study.
Trial locations and contacts
No sites are listed yet.
About this study
Official title: Efficacy of Platelet-rich Plasma With Fractional Erbium-YAG Laser Versus With Microneedling in Localized Stable Vitiligo
The aims of this study are to:- Compare the effect of fractional Erbium: YAG laser assisted delivery of platelet- rich plasma versus microneedling with platelet-rich plasma in the induction of skin repigmentation in localized stable vitiligo patients.
Read the detailed description
Vitiligo is a depigmentation disease characterised by epidermal melanocyte death and melanin loss. It affects less than 0.1% to greater than 8% of the world's population. It is caused by a dynamic interplay between genetic and environmental risks that initiates an autoimmune attack on melanocytes in the skin. There are some treatment modalities, such as topical steroids, topical calcineurin inhibitors, excimer laser, narrowband-ultraviolet B therapy (NB-UVB), vitamin D,and non-cultured epidermal cell suspension (NCES).
One of the representative autogenous regenerative biomaterials is platelet-rich plasma (PRP) which contains moderate to high concentrations of platelets together with multiple biomolecules and moderate concentrations of leucocytes. Activated platelets can release autogenous growth factors that may initiate a signalling cascades and lead to numerous intracellular changes, promoting the proliferation, migration, and differentiation of stem cells and regulating local inflammation and immune responses.
Laser- assisted drug delivery (LADD) functions by creating focused zones of selective epidermal damage thereby rendering the dermis more accessible to topical medication.
Multiple lasers have been applied for the purpose of LADD, including ablative fractional carbon dioxide (CO2) and erbium-doped yttrium-aluminum-garnet (Er: YAG) lasers.
Microneedling (Mn) is a minimally invasive process in which many tiny needles penetrate the skin. It augments transdermal drug delivery (TDD) through the creation of pores in the stratum corneum. This technique is also believed to induce pigmentation by physically moving melanocytes with the needles into the vitiligo areas from the pigmented areas, so that they may serve as reservoirs for melanogenesis, also it induces microinflammation which stimulates the migration of keratinocytes and melanocytes that induces the release of cytokines and growth factors stimulating melanocytes at the periphery of vitiligo patches and their migration from pigmented to unpigmented areas.
- Conditions
- Localized Vitiligo
- Being tested
- fractional Erbium-YAG laser, microneedling
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
fractional Erbium-YAG laserDevice
Platelet-rich plasma with fractional Erbium-YAG laser in localized stable vitiligo
microneedlingDevice
Platelet-rich plasma with microneedling in localized stable vitiligo
| Study group | Role | What they receive |
|---|---|---|
| fractional(Er: YAG) laser with platelet-rich plasma | Experimental | Subjected to fractional erbium: yttrium-aluminum-garnet (Er: YAG) laser (FotonaXs
* Dynamis, Slovenia) with the energy of 1400 mJ in short pulse mode (SP) with spot size of 7 mm diameter, frequency of 3 Hz, and pixel 1. PRP is applied over the treated areas.This procedure will be repeated every two weeks for six months Receives: Device: fractional Erbium-YAG laser |
| Microneedling with platelet-rich plasma | Experimental | Subjected to microneedling using electronic dermapen device (Dr Pen Derma Pen Ultima A6®) which has a disposable head that personalized for each patient and sterilized after each session. The derma pen will penetrate the skin with variable depths ranging from 0.25 to 0.5 mm (not more than the depth of the epidermis). It will pass vertically over the vitiligo area in a circular pattern from the perilesional areas toward the depigmented center until pinpoint bleeding appears then the PRP is applied over the treated areas.
- This procedure will be repeated every two weeks for six months. Receives: Device: microneedling |
What is being measured
The primary outcome is the main question the study is designed to answer.
percentage of skin repigmentation of localized stable vitiligo
according to Physician's Global Assessment [PGA] G4 (excellent: >75% repigmentation) G3 (very good: 50%-75% repigmentation) G2 (good: 25%-50% repigmentation)
G1 (satisfactory: <25% repigmentation)
G0 (poor: no repigmentation)
The start of color and textural changes of skin will be examined every month. Assessment of pattern of repigmentation as marginal, perifollicular, diffuse and combined .
Measured: six month
Secondary outcomes (1)
Response to treatment
Response to treatment will be evaluated by photographing the patients and Physician's Global Assessment [PGA] at the baseline before the treatment and monthly after starting the treatment to detect the correlation between the degrees of repigmentation in both groups
Measured: six month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Aug 2022
- Study start1 Oct 2022 (estimated)
- Primary completion1 Oct 2023 (estimated)
- Study completion1 Dec 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (11)Papers the sponsor has linked to this study.
- Other trials for Localized VitiligoStudies 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
- (Group A): Subjected to fractional erbium: yttrium-aluminum-garnet (Er: YAG) laser (FotonaXs Dynamis, Slovenia) with the energy of 1400 mJ in short pulse mode (SP) with spot size of 7 mm diameter, frequency of 3 Hz, and pixel 1. PRP is applied over the treated areas. (Group B): Subjected to microneedling using electronic dermapen device (Dr Pen Derma Pen Ultima A6®) which has a disposable head that personalized for each patient . The derma pen will penetrate the skin with variable depths ranging from 0.25 to 0.5 mm (not more than the depth of the epidermis). It will pass vertically over the vitiligo area in a circular pattern from the perilesional areas toward the depigmented center until pinpoint bleeding appears then the PRP is applied over the treated areas. * This procedure will be repeated every two weeks for six months.
- Masking
- None (open label)
- Enrolment
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- South Valley University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, aya marouf hameed aref, South Valley University
- Investigators
- Hassan M Ibrahim, Ass. Prof, Study director, southvalley universityEisa M Hegazy, Ass. Prof, Study director, southvalley universitySoheir ab Ali, Dr., Study director, southvalley university
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05511493
- Sponsor's protocol ID
- PRP in vitiligo
- Status last verified
- Aug 2022
- First submitted
- 18 Aug 2022
- Last updated
- 23 Aug 2022
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Jin Y, Andersen G, Yorgov D, Ferrara TM, Ben S, Brownson KM, Holland PJ, Birlea SA, Siebert J, Hartmann A, Lienert A, van Geel N, Lambert J, Luiten RM, Wolkerstorfer A, Wietze van der Veen JP, Bennett DC, Taieb A, Ezzedine K, Kemp EH, Gawkrodger DJ, Weetman AP, Koks S, Prans E, Kingo K, Karelson M, Wallace MR, McCormack WT, Overbeck A, Moretti S, Colucci R, Picardo M, Silverberg NB, Olsson M, Valle Y, Korobko I, Bohm M, Lim HW, Hamzavi I, Zhou L, Mi QS, Fain PR, Santorico SA, Spritz RA. Genome-wide association studies of autoimmune vitiligo identify 23 new risk loci and highlight key pathways and regulatory variants. Nat Genet. 2016 Nov;48(11):1418-1424. doi: 10.1038/ng.3680. Epub 2016 Oct 10.
PubMed 27723757Alikhan A, Felsten LM, Daly M, Petronic-Rosic V. Vitiligo: a comprehensive overview Part I. Introduction, epidemiology, quality of life, diagnosis, differential diagnosis, associations, histopathology, etiology, and work-up. J Am Acad Dermatol. 2011 Sep;65(3):473-491. doi: 10.1016/j.jaad.2010.11.061.
PubMed 21839315Rashighi M, Harris JE. Vitiligo Pathogenesis and Emerging Treatments. Dermatol Clin. 2017 Apr;35(2):257-265. doi: 10.1016/j.det.2016.11.014.
PubMed 28317534Whitton M, Pinart M, Batchelor JM, Leonardi-Bee J, Gonzalez U, Jiyad Z, Eleftheriadou V, Ezzedine K. Evidence-based management of vitiligo: summary of a Cochrane systematic review. Br J Dermatol. 2016 May;174(5):962-9. doi: 10.1111/bjd.14356. Epub 2016 Mar 25.
PubMed 26686510Chen J, Wan Y, Lin Y, Jiang H. The application of platelet-rich plasma for skin graft enrichment: A meta-analysis. Int Wound J. 2020 Dec;17(6):1650-1658. doi: 10.1111/iwj.13445. Epub 2020 Jul 7.
PubMed 32633467Lee WR, Shen SC, Al-Suwayeh SA, Li YC, Fang JY. Erbium:YAG laser resurfacing increases skin permeability and the risk of excessive absorption of antibiotics and sunscreens: the influence of skin recovery on drug absorption. Toxicol Lett. 2012 Jun 1;211(2):150-8. doi: 10.1016/j.toxlet.2012.03.797. Epub 2012 Mar 29.
PubMed 22483991Zaleski-Larsen LA, Fabi SG. Laser-Assisted Drug Delivery. Dermatol Surg. 2016 Aug;42(8):919-31. doi: 10.1097/DSS.0000000000000556.
PubMed 27191783Hou A, Cohen B, Haimovic A, Elbuluk N. Microneedling: A Comprehensive Review. Dermatol Surg. 2017 Mar;43(3):321-339. doi: 10.1097/DSS.0000000000000924.
PubMed 27755171Vandervoort J, Ludwig A. Microneedles for transdermal drug delivery: a minireview. Front Biosci. 2008 Jan 1;13:1711-5. doi: 10.2741/2794.
PubMed 17981662Wassef C, Lombardi A, Khokher S, Rao BK. Vitiligo surgical, laser, and alternative therapies: a review and case series. J Drugs Dermatol. 2013 Jun 1;12(6):685-91.
PubMed 23839187Abdel-Hamid S, Ibrahim HM, Hameed AM, Hegazy EM. Effectiveness of fractional erbium-YAG laser, microneedling, platelet-rich plasma in localized stable vitiligo patients: randomized clinical trial. Arch Dermatol Res. 2024 Jun 15;316(7):399. doi: 10.1007/s00403-024-03035-8.
PubMed 38878236
Study at a glance
From the registry record, last updated by the sponsor on 23 Aug 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy of Platelet-rich Plasma With Fractional Erbium-YAG Laser Versus With Microneedling in Localized Stable Vitiligo
- ClinicalTrials.gov ID
- NCT05511493
- Acronym / sponsor ID
- PRP in vitiligo
- Conditions
- Localized Vitiligo
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- South Valley UniversityUniversity, hospital or other
- Study start
- 1 Oct 2022 (estimated)
- Primary completion
- 1 Oct 2023 (estimated)
- Study completion
- 1 Dec 2023 (estimated)
- First posted
- 23 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.
The aims of this study are to:- Compare the effect of fractional Erbium: YAG laser assisted delivery of platelet- rich plasma versus microneedling with platelet-rich plasma in the induction of skin repigmentation in localized stable vitiligo patients.
Detailed description
Vitiligo is a depigmentation disease characterised by epidermal melanocyte death and melanin loss. It affects less than 0.1% to greater than 8% of the world's population. It is caused by a dynamic interplay between genetic and environmental risks that initiates an autoimmune attack on melanocytes in the skin. There are some treatment modalities, such as topical steroids, topical calcineurin inhibitors, excimer laser, narrowband-ultraviolet B therapy (NB-UVB), vitamin D,and non-cultured epidermal cell suspension (NCES).
One of the representative autogenous regenerative biomaterials is platelet-rich plasma (PRP) which contains moderate to high concentrations of platelets together with multiple biomolecules and moderate concentrations of leucocytes. Activated platelets can release autogenous growth factors that may initiate a signalling cascades and lead to numerous intracellular changes, promoting the proliferation, migration, and differentiation of stem cells and regulating local inflammation and immune responses.
Laser- assisted drug delivery (LADD) functions by creating focused zones of selective epidermal damage thereby rendering the dermis more accessible to topical medication.
Multiple lasers have been applied for the purpose of LADD, including ablative fractional carbon dioxide (CO2) and erbium-doped yttrium-aluminum-garnet (Er: YAG) lasers.
Microneedling (Mn) is a minimally invasive process in which many tiny needles penetrate the skin. It augments transdermal drug delivery (TDD) through the creation of pores in the stratum corneum. This technique is also believed to induce pigmentation by physically moving melanocytes with the needles into the vitiligo areas from the pigmented areas, so that they may serve as reservoirs for melanogenesis, also it induces microinflammation which stimulates the migration of keratinocytes and melanocytes that induces the release of cytokines and growth factors stimulating melanocytes at the periphery of vitiligo patches and their migration from pigmented to unpigmented areas.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- (Group A): Subjected to fractional erbium: yttrium-aluminum-garnet (Er: YAG) laser (FotonaXs Dynamis, Slovenia) with the energy of 1400 mJ in short pulse mode (SP) with spot size of 7 mm diameter, frequency of 3 Hz, and pixel 1. PRP is applied over the treated areas. (Group B): Subjected to microneedling using electronic dermapen device (Dr Pen Derma Pen Ultima A6®) which has a disposable head that personalized for each patient . The derma pen will penetrate the skin with variable depths ranging from 0.25 to 0.5 mm (not more than the depth of the epidermis). It will pass vertically over the vitiligo area in a circular pattern from the perilesional areas toward the depigmented center until pinpoint bleeding appears then the PRP is applied over the treated areas. * This procedure will be repeated every two weeks for six months.
| Arm | Type | Receives |
|---|---|---|
| fractional(Er: YAG) laser with platelet-rich plasma | Experimental | Device: fractional Erbium-YAG laserSubjected to fractional erbium: yttrium-aluminum-garnet (Er: YAG) laser (FotonaXs * Dynamis, Slovenia) with the energy of 1400 mJ in short pulse mode (SP) with spot size of 7 mm diameter, frequency of 3 Hz, and pixel 1. PRP is applied over the treated areas.This procedure will be repeated every two weeks for six months |
| Microneedling with platelet-rich plasma | Experimental | Device: microneedlingSubjected to microneedling using electronic dermapen device (Dr Pen Derma Pen Ultima A6®) which has a disposable head that personalized for each patient and sterilized after each session. The derma pen will penetrate the skin with variable depths ranging from 0.25 to 0.5 mm (not more than the depth of the epidermis). It will pass vertically over the vitiligo area in a circular pattern from the perilesional areas toward the depigmented center until pinpoint bleeding appears then the PRP is applied over the treated areas. - This procedure will be repeated every two weeks for six months. |
Who may qualify
- Ages
- 10 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (2 listed)
- 1) Patients of both sexes with stable localized vitiligo: stable patches (should not have any increase or decrease in size or pigmentation for at least 3 months) .
- 2)Age between 10 - 60 years
Key exclusion criteria (5 listed)
- 1)Acute or chronic infections. 2) Koebner phenomenon. 3) Contraindications to PRP injections:
- 4) We also excluded pregnant or lactating women. 5) All patients included had not received any local or systemic medication for at least 2 months before the study.
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 |
|---|---|---|
| fractional Erbium-YAG laserPlatelet-rich plasma with fractional Erbium-YAG laser in localized stable vitiligo | Device | fractional(Er: YAG) laser with platelet-rich plasma |
| microneedlingPlatelet-rich plasma with microneedling in localized stable vitiligo | Device | Microneedling with platelet-rich plasma |
Primary outcome
percentage of skin repigmentation of localized stable vitiligo
Time frame: six month
according to Physician's Global Assessment [PGA] G4 (excellent: >75% repigmentation) G3 (very good: 50%-75% repigmentation) G2 (good: 25%-50% repigmentation) G1 (satisfactory: <25% repigmentation) G0 (poor: no repigmentation) The start of color and textural changes of skin will be examined every month. Assessment of pattern of repigmentation as marginal, perifollicular, diffuse and combined .
1 secondary outcome
Response to treatment
Time frame: six month
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Aug 2022.
- Background: PubMed 27723757Jin Y, Andersen G, Yorgov D, Ferrara TM, Ben S, Brownson KM, Holland PJ, Birlea SA, Siebert J, Hartmann A, Lienert A, van Geel N, Lambert J, Luiten RM, Wolkerstorfer A, Wietze van der Veen JP, Bennett DC, Taieb A, Ezzedine K, Kemp EH, Gawkrodger DJ, Weetman AP, Koks S, Prans E, Kingo K, Karelson M, Wallace MR, McCormack WT, Overbeck A, Moretti S, Colucci R, Picardo M, Silverberg NB, Olsson M, Valle Y, Korobko I, Bohm M, Lim HW, Hamzavi I, Zhou L, Mi QS, Fain PR, Santorico SA, Spritz RA. Genome-wide association studies of autoimmune vitiligo identify 23 new risk loci and highlight key pathways and regulatory variants. Nat Genet. 2016 Nov;48(11):1418-1424. doi: 10.1038/ng.3680. Epub 2016 Oct 10.
- Background: PubMed 21839315Alikhan A, Felsten LM, Daly M, Petronic-Rosic V. Vitiligo: a comprehensive overview Part I. Introduction, epidemiology, quality of life, diagnosis, differential diagnosis, associations, histopathology, etiology, and work-up. J Am Acad Dermatol. 2011 Sep;65(3):473-491. doi: 10.1016/j.jaad.2010.11.061.
- Background: PubMed 28317534Rashighi M, Harris JE. Vitiligo Pathogenesis and Emerging Treatments. Dermatol Clin. 2017 Apr;35(2):257-265. doi: 10.1016/j.det.2016.11.014.
- Background: PubMed 26686510Whitton M, Pinart M, Batchelor JM, Leonardi-Bee J, Gonzalez U, Jiyad Z, Eleftheriadou V, Ezzedine K. Evidence-based management of vitiligo: summary of a Cochrane systematic review. Br J Dermatol. 2016 May;174(5):962-9. doi: 10.1111/bjd.14356. Epub 2016 Mar 25.
- Background: PubMed 32633467Chen J, Wan Y, Lin Y, Jiang H. The application of platelet-rich plasma for skin graft enrichment: A meta-analysis. Int Wound J. 2020 Dec;17(6):1650-1658. doi: 10.1111/iwj.13445. Epub 2020 Jul 7.
- Background: PubMed 22483991Lee WR, Shen SC, Al-Suwayeh SA, Li YC, Fang JY. Erbium:YAG laser resurfacing increases skin permeability and the risk of excessive absorption of antibiotics and sunscreens: the influence of skin recovery on drug absorption. Toxicol Lett. 2012 Jun 1;211(2):150-8. doi: 10.1016/j.toxlet.2012.03.797. Epub 2012 Mar 29.
- Background: PubMed 27191783Zaleski-Larsen LA, Fabi SG. Laser-Assisted Drug Delivery. Dermatol Surg. 2016 Aug;42(8):919-31. doi: 10.1097/DSS.0000000000000556.
- Background: PubMed 27755171Hou A, Cohen B, Haimovic A, Elbuluk N. Microneedling: A Comprehensive Review. Dermatol Surg. 2017 Mar;43(3):321-339. doi: 10.1097/DSS.0000000000000924.
- Background: PubMed 17981662Vandervoort J, Ludwig A. Microneedles for transdermal drug delivery: a minireview. Front Biosci. 2008 Jan 1;13:1711-5. doi: 10.2741/2794.
- Background: PubMed 23839187Wassef C, Lombardi A, Khokher S, Rao BK. Vitiligo surgical, laser, and alternative therapies: a review and case series. J Drugs Dermatol. 2013 Jun 1;12(6):685-91.
- Derived from this study: PubMed 38878236Abdel-Hamid S, Ibrahim HM, Hameed AM, Hegazy EM. Effectiveness of fractional erbium-YAG laser, microneedling, platelet-rich plasma in localized stable vitiligo patients: randomized clinical trial. Arch Dermatol Res. 2024 Jun 15;316(7):399. doi: 10.1007/s00403-024-03035-8.
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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.
Hassan M Ibrahim, Ass. Prof study director
southvalley university
Eisa M Hegazy, Ass. Prof study director
southvalley university
Soheir ab Ali, Dr. study director
southvalley university
Questions about this trial
What is this clinical trial studying?
A study testing fractional Erbium-YAG laser and microneedling in people with Localized Vitiligo, run by South Valley University.
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 2 inclusion and 5 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 23 Aug 2022. Status can change between updates, so confirm with the study contact before making plans.
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 aya ma hameed, resident (01091029334, ayamarouf956@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
percentage of skin repigmentation of localized stable vitiligo (time frame: six month). 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 NCT05511493, which also lists 11 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 23 Aug 2022.