VitiligoNCT03155698
Treatment of Acral Vitiligo : Narrowband Ultraviolet-B and Microneedling With and Without Platelet Rich Plasma
A study testing microneedling and Platelet rich plasma and NB-UVB phototherapy in people with Vitiligo, run by Assiut University at 1 site in Egypt.
Trial summary
Vitiligo is a relatively common acquired chronic disorder of pigmentation characterized by the development of white macules on the skin due to loss of epidermal melanocytes .Affecting approximately 0.5%-2% of general population worldwide, without predilection for sex or race. Read more about this study
- Who is it for?
- Ages 18 to 45 years
- Conditions the study is for
- Vitiligo
- What is being tested?
- microneedling and Platelet rich plasma and NB-UVB phototherapy
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- 1 siteEgypt
- Study dates
- Aug 2021to Dec 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 18 to 45 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- Patients older than 18 years.
- Patients with bilateral and symmetrical vitiligo acral in distribution.
- Lesions stable for at least three months.
- Patients receiving topical treatment will be required to undergo two weeks washout period.
- Patients receiving systemic treatment will be required to undergo 1 month washout period.
- Patients who were unresponsive to medical treatment or photo therapy.
- No sex predilection
Who cannot join
- Haemoglobin< 10 g/dl.
- Platelet count < 105 /UL.
- Patients with active infection.
- Reported histories of koebnerization.
- History of keloid formation or hypertrophic scars.
- Pregnant or lactating females.
Show all 9Show fewer
- Bleeding tendency.
- Patients with chronic liver diseases.
- Patients using systemic chemotherapy, anti-coagulation therapy and antiplatelet agents.
Trial locations and contacts
1 site in 1 country.
About this study
Vitiligo is a relatively common acquired chronic disorder of pigmentation characterized by the development of white macules on the skin due to loss of epidermal melanocytes .Affecting approximately 0.5%-2% of general population worldwide, without predilection for sex or race.
Read the detailed description
Lesions may occur in a localized or generalized distribution and may coalesce into large, depigmented areas. Given the contrast between the white areas and normal skin, the disease is most disfiguring in darker skin types and has a profound impact on the quality of life of both children and adults. Generalized vitiligo is the most common clinical presentation and often involves the face and acral regions. The acral and joint areas are common sites of occurrence of vitiliginous lesions, because they are areas subjected to repeated trauma or irritation . The acral lesions are more visible and cosmetically important than lesions at many other sites, causing greater psychosocial distress Acral lesions are usually more resistant to medical management . Several reasons have been put forward, including relatively low melanocyte density; minimal density of hair follicles, which are a melanocyte reservoir; and a greater chance of repeated friction or trauma, which can induce koebnerization. Both acral and joint lesions also tend to be resistant to surgical management . The narrow band-ultraviolet B phototherapy is considered to be a very important modality in vitiligo treatment since its first use in 1997. It was proved to be of higher efficacy, better tolerated, and superior to the other lines of treatment . The prolonged duration of narrow band-ultraviolet B therapy is the main reason for noncompliance, distance to be traveled and monetary, and time loss in attending the hospital at least twice a week for prolonged time were cited as the second common cause for attrition. This clearly increases the need for combined therapy with narrow band-ultraviolet B (NB-UVB) to shorten the duration.
Combined treatments have been found to be superior to monotherapies regarding efficacy, early response and safety, especially in difficult to treat areas and refractory cases .
Platelet-rich plasma (PRP) is an autologous preparation of platelets in concentrated plasma.
Various growth factors, including platelet-derived growth factor, transforming growth factor, vascular endothelial growth factor, and insulin-like growth factor, are secreted from α-granules of concentrated platelets activated by aggregation inducers .
The beneficial effect of platelet rich plasma in vitiligo could be suggested through these growth factors which stimulate keratinocytes and fibroblasts proliferation with subsequent improvement of their interaction with melanocytes leading to the stabilization of melanocytes, it was also found that platelet rich plasma treatment induced accelerated proliferation and migration of fibroblasts through up-regulation of cyclin E and Cyclin- dependent kinase 4, which is important in cell migration and proliferation . Skin micro needling is a technique predominantly used to improve the appearance of cutaneous scarring and photo damage, fine needles puncture the skin, resulting in increased dermal elastin and collagen, collagen remodeling, and thickening of the epidermis and dermis . Additionally, skin needling creates small channels, which increase the absorption of topically applied preparations which has been used in various dermatological treatments.
.Aim of the work:
- To determine efficacy and safety of automated microneedling + topical platelet rich plasma in combination with narrowband- ultraviolet B in treatment of resistant acral vitiligo.
- To compare the efficacy of automated microneedling + topical Platelet rich plasma in combination with narrowband ultraviolet B versus automated microneedling and narrowband ultraviolet B only in treatment of resistant acral vitiligo.
- Conditions
- Vitiligo
- Being tested
- microneedling and Platelet rich plasma, NB-UVB phototherapy
- Medical subject headings
- Vitiligo
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
microneedling and Platelet rich plasmaCombination product
Also called dermapen+ topical PRP
Patient's skin is first cleaned with ethyl alcohol. Topical anaesthetic cream is then applied to skin for 30 min. Once anaesthesias is fully developed, Dermapen will be applied on the lesional skin in four direction, vertical, horizontal and the two diagonal until pin point bleeding occur which will be gently massaged.
- After ten minutes the prepared platelet rich plasma will be applied topically and after about 2 minutes. Occlusive dressing will be done and kept for 1 day then the patient will use topical antibiotic. The procedure will be repeated every 15 days.
NB-UVB phototherapyRadiation
All patients will receive NB-UVB twice weekly for maximum 6 months, starting with a dose of 0.21 J/cm² independent of skin type and increased by 20% every session until we reach the minimal erythema dose
| Study group | Role | What they receive |
|---|---|---|
| microneedling,NB-UVB with & without PRP | Experimental | Each participant will be compared with one side of the body to the other side
Intervention:
* Combination Product: microneedling and Platelet rich plasma.
* radiation : NB-UVB phototherapy Receives: Combination Product: microneedling and Platelet rich plasma; Radiation: NB-UVB phototherapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
VASI score-Vitiligo Area and Severity Index
Vitiligo Area and Severity Index (VASI) One hand unit, which encompasses the palm plus the volar surface of all the digits, is approximately 1% of the total body surface area and is used to estimate the baseline percentage of vitiligo involvement in each body region. The body is divided into five separate and mutually exclusive regions: hands, upper extremities (excluding hands), trunk, lower extremities (excluding feet), and feet. The axillary region is included with the upper extremities while the buttocks and inguinal areas are included with the lower extremities. The extent of residual depigmentation is expressed by the following percentages: 0, 10%, 25%, 50%, 75%, 90%, or 100%. At 100% depigmentation, no pigment is present; at 90%, specks of pigment are present; at 75%, the depigmented area exceeds the pigmented area; at 50%, the depigmented and pigmented areas are equal; at 25%, the pigmented area exceeds the depigmented area; at 10%, only specks of depigmentation
Measured: within 6 months
Secondary outcomes (2)
scoring system of repigmentation
- G0, < 25% repigmentation (poor)
- G1, 25-50% repigmentation (fair)
- G2, 50-75% repigmentation (good)
- G3 > 75% repigmentation (excellent).
Measured: assessed 6 months following application of intervention
Patients satisfaction
The patient overall satisfaction will be assessed according to Overall satisfaction:
- dissatisfied
- neutral
- somewhat satisfied
- moderately satisfied
- very satisfied
Measured: within 6months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 May 2017
- Study startAug 2021 (estimated)
- Primary completionSep 2021 (estimated)
- Study completionDec 2021 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (10)Papers the sponsor has linked to this study.
- Other trials for VitiligoStudies of the same condition, open and under way.
- More trials run by Assiut UniversityThe sponsor's other registered studies.
- 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
- Not applicable
- Intervention model
- Single group
- Model description
- Enrolled subjects will be randomized to treatment with microneedling by using dermapen every two weeks while the contralateral side of the body will be treated by microneedling plus topical PRP every two weeks .Then both sides of the body will receive narrowband UVB twice weekly for 6 month,
- Masking
- None (open label)
- Enrolment
- 50 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Assiut University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Lamia Ahmed, Assiut University
- Investigators
- Lamiaa Ahmad Abd El-khalek, Principal investigator, Assiut University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03155698
- Sponsor's protocol ID
- TOAV
- Status last verified
- Jul 2021
- First submitted
- 11 May 2017
- Last updated
- 7 Jul 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Ezzedine K, Eleftheriadou V, Whitton M, van Geel N. Vitiligo. Lancet. 2015 Jul 4;386(9988):74-84. doi: 10.1016/S0140-6736(14)60763-7. Epub 2015 Jan 15.
PubMed 25596811Kruger C, Schallreuter KU. Stigmatisation, Avoidance Behaviour and Difficulties in Coping are Common Among Adult Patients with Vitiligo. Acta Derm Venereol. 2015 May;95(5):553-8. doi: 10.2340/00015555-1981.
PubMed 25269389Olsson MJ, Juhlin L. Long-term follow-up of leucoderma patients treated with transplants of autologous cultured melanocytes, ultrathin epidermal sheets and basal cell layer suspension. Br J Dermatol. 2002 Nov;147(5):893-904. doi: 10.1046/j.1365-2133.2002.04837.x.
PubMed 12410698Holla AP, Parsad D. Vitiligo surgery: its evolution as a definite treatment in the stable vitiligo. G Ital Dermatol Venereol. 2010 Feb;145(1):79-88.
PubMed 20197747Westerhof W, Nieuweboer-Krobotova L. Treatment of vitiligo with UV-B radiation vs topical psoralen plus UV-A. Arch Dermatol. 1997 Dec;133(12):1525-8.
PubMed 9420536Kandaswamy S, Akhtar N, Ravindran S, Prabhu S, Shenoi SD. Phototherapy in Vitiligo: Assessing the Compliance, Response and Patient's Perception about Disease and Treatment. Indian J Dermatol. 2013 Jul;58(4):325. doi: 10.4103/0019-5154.113944.
PubMed 23919018Kaux JF, Le Goff C, Seidel L, Peters P, Gothot A, Albert A, Crielaard JM. [Comparative study of five techniques of preparation of platelet-rich plasma]. Pathol Biol (Paris). 2011 Jun;59(3):157-60. doi: 10.1016/j.patbio.2009.04.007. Epub 2009 May 28. French.
PubMed 19481375Aust MC, Reimers K, Kaplan HM, Stahl F, Repenning C, Scheper T, Jahn S, Schwaiger N, Ipaktchi R, Redeker J, Altintas MA, Vogt PM. Percutaneous collagen induction-regeneration in place of cicatrisation? J Plast Reconstr Aesthet Surg. 2011 Jan;64(1):97-107. doi: 10.1016/j.bjps.2010.03.038. Epub 2010 Apr 21.
PubMed 20413357Fabbrocini G, De Vita V, Izzo R, Monfrecola G. The use of skin needling for the delivery of a eutectic mixture of local anesthetics. G Ital Dermatol Venereol. 2014 Oct;149(5):581-5.
PubMed 25213385Gonshor A. Technique for producing platelet-rich plasma and platelet concentrate: background and process. Int J Periodontics Restorative Dent. 2002 Dec;22(6):547-57.
PubMed 12516826
Study at a glance
From the registry record, last updated by the sponsor on 7 Jul 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Treatment of Acral Vitiligo : Narrowband Ultraviolet-B and Microneedling With and Without Platelet Rich Plasma
- ClinicalTrials.gov ID
- NCT03155698
- Acronym / sponsor ID
- TOAV
- Conditions
- Vitiligo
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- Assiut UniversityUniversity, hospital or other
- Study start
- Aug 2021 (estimated)
- Primary completion
- Sep 2021 (estimated)
- Study completion
- Dec 2021 (estimated)
- First posted
- 16 May 2017 (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.
Vitiligo is a relatively common acquired chronic disorder of pigmentation characterized by the development of white macules on the skin due to loss of epidermal melanocytes .Affecting approximately 0.5%-2% of general population worldwide, without predilection for sex or race.
Detailed description
Lesions may occur in a localized or generalized distribution and may coalesce into large, depigmented areas. Given the contrast between the white areas and normal skin, the disease is most disfiguring in darker skin types and has a profound impact on the quality of life of both children and adults. Generalized vitiligo is the most common clinical presentation and often involves the face and acral regions. The acral and joint areas are common sites of occurrence of vitiliginous lesions, because they are areas subjected to repeated trauma or irritation . The acral lesions are more visible and cosmetically important than lesions at many other sites, causing greater psychosocial distress Acral lesions are usually more resistant to medical management . Several reasons have been put forward, including relatively low melanocyte density; minimal density of hair follicles, which are a melanocyte reservoir; and a greater chance of repeated friction or trauma, which can induce koebnerization. Both acral and joint lesions also tend to be resistant to surgical management . The narrow band-ultraviolet B phototherapy is considered to be a very important modality in vitiligo treatment since its first use in 1997. It was proved to be of higher efficacy, better tolerated, and superior to the other lines of treatment . The prolonged duration of narrow band-ultraviolet B therapy is the main reason for noncompliance, distance to be traveled and monetary, and time loss in attending the hospital at least twice a week for prolonged time were cited as the second common cause for attrition. This clearly increases the need for combined therapy with narrow band-ultraviolet B (NB-UVB) to shorten the duration.
Combined treatments have been found to be superior to monotherapies regarding efficacy, early response and safety, especially in difficult to treat areas and refractory cases .
Platelet-rich plasma (PRP) is an autologous preparation of platelets in concentrated plasma.
Various growth factors, including platelet-derived growth factor, transforming growth factor, vascular endothelial growth factor, and insulin-like growth factor, are secreted from α-granules of concentrated platelets activated by aggregation inducers .
The beneficial effect of platelet rich plasma in vitiligo could be suggested through these growth factors which stimulate keratinocytes and fibroblasts proliferation with subsequent improvement of their interaction with melanocytes leading to the stabilization of melanocytes, it was also found that platelet rich plasma treatment induced accelerated proliferation and migration of fibroblasts through up-regulation of cyclin E and Cyclin- dependent kinase 4, which is important in cell migration and proliferation . Skin micro needling is a technique predominantly used to improve the appearance of cutaneous scarring and photo damage, fine needles puncture the skin, resulting in increased dermal elastin and collagen, collagen remodeling, and thickening of the epidermis and dermis . Additionally, skin needling creates small channels, which increase the absorption of topically applied preparations which has been used in various dermatological treatments.
.Aim of the work:
- To determine efficacy and safety of automated microneedling + topical platelet rich plasma in combination with narrowband- ultraviolet B in treatment of resistant acral vitiligo.
- To compare the efficacy of automated microneedling + topical Platelet rich plasma in combination with narrowband ultraviolet B versus automated microneedling and narrowband ultraviolet B only in treatment of resistant acral vitiligo.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- Enrolled subjects will be randomized to treatment with microneedling by using dermapen every two weeks while the contralateral side of the body will be treated by microneedling plus topical PRP every two weeks .Then both sides of the body will receive narrowband UVB twice weekly for 6 month,
| Arm | Type | Receives |
|---|---|---|
| microneedling,NB-UVB with & without PRP | Experimental | Combination Product: microneedling and Platelet rich plasma, Radiation: NB-UVB phototherapyEach participant will be compared with one side of the body to the other side Intervention: * Combination Product: microneedling and Platelet rich plasma. * radiation : NB-UVB phototherapy |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (7 listed)
- Patients older than 18 years.
- Patients with bilateral and symmetrical vitiligo acral in distribution.
- Lesions stable for at least three months.
- Patients receiving topical treatment will be required to undergo two weeks washout period.
- Patients receiving systemic treatment will be required to undergo 1 month washout period.
Key exclusion criteria (9 listed)
- Haemoglobin< 10 g/dl.
- Platelet count < 105 /UL.
- Patients with active infection.
- Reported histories of koebnerization.
- History of keloid formation or hypertrophic scars.
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 |
|---|---|---|
| microneedling and Platelet rich plasmaAlso: dermapen+ topical PRPPatient's skin is first cleaned with ethyl alcohol. Topical anaesthetic cream is then applied to skin for 30 min. Once anaesthesias is fully developed, Dermapen will be applied on the lesional skin in four direction, vertical, horizontal and the two diagonal until pin point bleeding occur which will be gently massaged. * After ten minutes the prepared platelet rich plasma will be applied topically and after about 2 minutes. Occlusive dressing will be done and kept for 1 day then the patient will use topical antibiotic. The procedure will be repeated every 15 days. | Combination product | microneedling,NB-UVB with & without PRP |
| NB-UVB phototherapyAll patients will receive NB-UVB twice weekly for maximum 6 months, starting with a dose of 0.21 J/cm² independent of skin type and increased by 20% every session until we reach the minimal erythema dose | Radiation | microneedling,NB-UVB with & without PRP |
Primary outcome
VASI score-Vitiligo Area and Severity Index
Time frame: within 6 months
Vitiligo Area and Severity Index (VASI) One hand unit, which encompasses the palm plus the volar surface of all the digits, is approximately 1% of the total body surface area and is used to estimate the baseline percentage of vitiligo involvement in each body region. The body is divided into five separate and mutually exclusive regions: hands, upper extremities (excluding hands), trunk, lower extremities (excluding feet), and feet. The axillary region is included with the upper extremities while the buttocks and inguinal areas are included with the lower extremities. The extent of residual depigmentation is expressed by the following percentages: 0, 10%, 25%, 50%, 75%, 90%, or 100%. At 100% depigmentation, no pigment is present; at 90%, specks of pigment are present; at 75%, the depigmented area exceeds the pigmented area; at 50%, the depigmented and pigmented areas are equal; at 25%, the pigmented area exceeds the depigmented area; at 10%, only specks of depigmentation
2 secondary outcomes
scoring system of repigmentation
Time frame: assessed 6 months following application of intervention
Patients satisfaction
Time frame: within 6months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Jul 2021.
- Results publication: PubMed 25596811Ezzedine K, Eleftheriadou V, Whitton M, van Geel N. Vitiligo. Lancet. 2015 Jul 4;386(9988):74-84. doi: 10.1016/S0140-6736(14)60763-7. Epub 2015 Jan 15.
- Results publication: PubMed 25269389Kruger C, Schallreuter KU. Stigmatisation, Avoidance Behaviour and Difficulties in Coping are Common Among Adult Patients with Vitiligo. Acta Derm Venereol. 2015 May;95(5):553-8. doi: 10.2340/00015555-1981.
- Results publication: PubMed 12410698Olsson MJ, Juhlin L. Long-term follow-up of leucoderma patients treated with transplants of autologous cultured melanocytes, ultrathin epidermal sheets and basal cell layer suspension. Br J Dermatol. 2002 Nov;147(5):893-904. doi: 10.1046/j.1365-2133.2002.04837.x.
- Results publication: PubMed 20197747Holla AP, Parsad D. Vitiligo surgery: its evolution as a definite treatment in the stable vitiligo. G Ital Dermatol Venereol. 2010 Feb;145(1):79-88.
- Results publication: PubMed 9420536Westerhof W, Nieuweboer-Krobotova L. Treatment of vitiligo with UV-B radiation vs topical psoralen plus UV-A. Arch Dermatol. 1997 Dec;133(12):1525-8.
- Results publication: PubMed 23919018Kandaswamy S, Akhtar N, Ravindran S, Prabhu S, Shenoi SD. Phototherapy in Vitiligo: Assessing the Compliance, Response and Patient's Perception about Disease and Treatment. Indian J Dermatol. 2013 Jul;58(4):325. doi: 10.4103/0019-5154.113944.
- Results publication: PubMed 19481375Kaux JF, Le Goff C, Seidel L, Peters P, Gothot A, Albert A, Crielaard JM. [Comparative study of five techniques of preparation of platelet-rich plasma]. Pathol Biol (Paris). 2011 Jun;59(3):157-60. doi: 10.1016/j.patbio.2009.04.007. Epub 2009 May 28. French.
- Results publication: PubMed 20413357Aust MC, Reimers K, Kaplan HM, Stahl F, Repenning C, Scheper T, Jahn S, Schwaiger N, Ipaktchi R, Redeker J, Altintas MA, Vogt PM. Percutaneous collagen induction-regeneration in place of cicatrisation? J Plast Reconstr Aesthet Surg. 2011 Jan;64(1):97-107. doi: 10.1016/j.bjps.2010.03.038. Epub 2010 Apr 21.
- Results publication: PubMed 25213385Fabbrocini G, De Vita V, Izzo R, Monfrecola G. The use of skin needling for the delivery of a eutectic mixture of local anesthetics. G Ital Dermatol Venereol. 2014 Oct;149(5):581-5.
- Results publication: PubMed 12516826Gonshor A. Technique for producing platelet-rich plasma and platelet concentrate: background and process. Int J Periodontics Restorative Dent. 2002 Dec;22(6):547-57.
- 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.
Lamiaa Ahmad Abd El-khalek principal investigator
Assiut 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 microneedling and Platelet rich plasma and NB-UVB phototherapy in people with Vitiligo, run by Assiut University at 1 site in Egypt.
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 7 inclusion and 9 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 7 Jul 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 Egypt. 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 Nagwa Essa Abd EL-Azim, MD (01280994337, nagwaeasa@yahoo.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
VASI score-Vitiligo Area and Severity Index (time frame: within 6 months). 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 NCT03155698, which also lists 10 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 7 Jul 2021.