Brow PtosisPhase 3NCT03219580
The Role of 5-Fluorouracil in Post-Operative Scar Formation Following Direct Brow Ptosis Repair
A Phase 3 study testing 5-Fluorouracil and Normal Saline Flush, 0.9% Injectable Solution in people with Brow Ptosis and Facial Scarring, run by Eyelid and Facial Consultants at 2 sites in United States.
Trial summary
This is a double (physician and patient) blinded randomized controlled clinical trial in which patients who have undergone bilateral direct brow ptosis repair undergo a trial in which one of brow is injected with placebo 0.9% Normal Saline and the contra-lateral brow is injected with 0.3-0.6 mL over the entire brow of… Read more about this study
- Who is it for?
- Ages 40 to 90 yearsHealthy volunteers can take part
- Conditions the study is for
- Brow Ptosis, Facial Scarring
- What is being tested?
- 5-Fluorouracil and Normal Saline Flush, 0.9% Injectable Solution
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 50 participants
- Where
- 2 sitesUnited States
- Study dates
- 20 May 2017to 1 Aug 2020
- Phase
- Phase 3
- 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 40 to 90 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Patients who have undergone bilateral direct brow ptosis repair (either cosmetic of functional)
Who cannot join
- Known prior knowledge of the study's existence
- History of hypertrophic scarring
- Prior brow surgery, prior incisions or trauma to the forehead, brow or peri-ocular area in the past
- Patients who are decisionally or mentally impaired as they will be required to fill out the supplied survey and have the capacity for consent for the treatment
- Patients with any disease which may affect the brow (e.g. Myasthenia Gravis)
- Actively being treated for malignancy
- Uncontrolled autoimmune diseases with skin involvement
Trial locations and contacts
2 sites in 1 country.
United States2 sites
Leonard J. Chabert Medical Center
Houma, Louisiana, 70363
Eyelid and Facial Consultants
New Orleans, Louisiana, 70115
About this study
This is a double (physician and patient) blinded randomized controlled clinical trial in which patients who have undergone bilateral direct brow ptosis repair undergo a trial in which one of brow is injected with placebo 0.9% Normal Saline and the contra-lateral brow is injected with 0.3-0.6 mL over the entire brow of 50mg/mL 5-Fluorouracil sub-dermal injections. The researchers aim to investigate whether injecting 5-Fluorouracil preemptively will not only accelerate wound healing and decrease hypertrophic scar formation compared to placebo, but also improve overall scar appearance in a safe manner.
Read the detailed description
In this double-blinded (physician and patient) randomized controlled clinical trial, the patient's left and right brows are randomized to either the placebo or treatment arm of the study and maintain this designation for the entirety of the study. This randomization is performed and recorded by the study nurse in the physician's office. This study nurse also will be responsible for preparing the placebo 0.9% Normal Saline (0.9%NS) and the 50mg/mL 5-Fluorouracil (5-FU). Both placebo and 5-FU are placed into identical syringes with 30 gauge needles, both materials are identical in color and clarity, making it impossible for physician or patient to correctly identify which injection is which without a label. Only the study nurse will be aware of which injection is which, and the nurse will ensure that the correct injection is placed into the correct brow at each visit via the study log that the nurse maintains.
A patient who has undergone bilateral direct brow ptosis repair who has agreed to participate in the study will first return for the post-operative day 10 visit where sutures are removed from the brow incisions. The patient returns on post-operative week three for their first injections, the details of which are below:
Starting on post-operative week three, the patient will receive 0.05mL aliquots of each injection (0.9%NS and 5-FU) sub-dermally into the brow incision spread out evenly over the brow, totaling 0.3-0.6 mL of each injection over each respective brow. Photos of the patient's brows will be taken, and then both the physician and patient will fill out a survey recording their impressions, the contents of which are listed in subsequent sections of this protocol. This same procedure will be repeated every three weeks for a total of up to four rounds of injections, thus the final round of injections will be given on post-operative week twelve. At each of these post-operative visits, incidence of any side effects is recorded, and if an unacceptably high rate of side effects occurs, the study will be precociously terminated.
At post-operative week fifteen, the blind is broken, and again photos are taken and physician and patient impressions are recorded via survey. After the blind is broken, if desired, the patient can opt to undergo a similar series of injections on the placebo arm of 5-FU.
- Conditions
- Brow Ptosis, Facial Scarring
- Being tested
- 5-Fluorouracil, Normal Saline Flush, 0.9% Injectable Solution
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
5-FluorouracilDrug
50mg/ml concentration of 5-Fluorouracil to be injected intra-dermally in direct brow skin incisions
Normal Saline Flush, 0.9% Injectable SolutionDrug
0.9% concentration of Normal Saline Injectable Solution to be injected intra-dermally in direct brow skin incisions
| Study group | Role | What they receive |
|---|---|---|
| 5-Fluorouracil Active Treatment Arm | Active comparator | A patient who has undergone bilateral direct brow ptosis repair and has elected to participate in the study will first have each of their brows randomized to either be the active treatment arm or the placebo arm. The active treatment arm brow will be injected with 0.05ml of 5-Fluorouracil 50mg/ml in several injections evenly spaced over the brow incision for a total of 0.3-0.6ml, repeated every three weeks for a total of 4 series of injections. Receives: Drug: 5-Fluorouracil |
| Placebo Arm | Placebo comparator | A patient who has undergone bilateral direct brow ptosis repair and has elected to participate in the study will first have each of their brows randomized to either be the active treatment arm or the placebo arm. The placebo arm brow will be injected with 0.05ml of 0.9% Normal Saline in several injections evenly spaced over the brow incision for a total of 0.3-0.6ml, repeated every three weeks for a total of 4 series of injections. Receives: Drug: Normal Saline Flush, 0.9% Injectable Solution |
What is being measured
The primary outcome is the main question the study is designed to answer.
Overall appearance
Patient and physician impression of overall appearance of the direct brow incision scar
Measured: 1 year
Skin tone match
Patient and physician impression of how close the direct brow incision scar matches the patient's natural skin tone/color
Measured: 1 year
Scar roughness/tough to touch
Patient and physician impression as to the degree of rough to the touch (ie fibrosis) is present in the direct brow incision scar
Measured: 1 year
Scar is flush with eyebrow
Patient and physician impressions as to degree that direct brow incision scar is flush with skin of the brow
Measured: 1 year
Secondary outcomes (1)
Incidence of side effects
Any incidence of any side effects
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Jul 2017
- Study start20 May 2017
- Primary completion30 Apr 2020 (estimated)
- Study completion1 Aug 2020 (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 Brow PtosisStudies 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 3
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Patients who undergo bilateral direct brow ptosis repair will be randomized to have one brow as the placebo arm and one arm as the active treatment arm. This original randomization will be maintained throughout the study.
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 50 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Eyelid and Facial Consultants
- Sponsor type
- University, hospital or other
- Collaborators
- Ochsner Health System
- Responsible party
- Sponsor
- Investigators
- Adham B. al Hariri, M.D., Principal investigator, Eyelid and Facial Consultants New Orleans
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03219580
- Sponsor's protocol ID
- LSUIRB#9586
- Status last verified
- Jul 2018
- First submitted
- 13 Jul 2017
- Last updated
- 26 Jul 2018
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Wendling J, Marchand A, Mauviel A, Verrecchia F. 5-fluorouracil blocks transforming growth factor-beta-induced alpha 2 type I collagen gene (COL1A2) expression in human fibroblasts via c-Jun NH2-terminal kinase/activator protein-1 activation. Mol Pharmacol. 2003 Sep;64(3):707-13. doi: 10.1124/mol.64.3.707.
PubMed 12920208Yoo DB, Azizzadeh B, Massry GG. Injectable 5-FU with or without added steroid in periorbital skin grafting: initial observations. Ophthalmic Plast Reconstr Surg. 2015 Mar-Apr;31(2):122-6. doi: 10.1097/IOP.0000000000000214.
PubMed 25025385Poetschke J, Gauglitz GG. Current options for the treatment of pathological scarring. J Dtsch Dermatol Ges. 2016 May;14(5):467-77. doi: 10.1111/ddg.13027.
PubMed 27119465Gupta S, Kalra A. Efficacy and safety of intralesional 5-fluorouracil in the treatment of keloids. Dermatology. 2002;204(2):130-2. doi: 10.1159/000051830.
PubMed 11937738Kontochristopoulos G, Stefanaki C, Panagiotopoulos A, Stefanaki K, Argyrakos T, Petridis A, Katsambas A. Intralesional 5-fluorouracil in the treatment of keloids: an open clinical and histopathologic study. J Am Acad Dermatol. 2005 Mar;52(3 Pt 1):474-9. doi: 10.1016/j.jaad.2004.09.018.
PubMed 15761426Fang QQ, Chen CY, Zhang MX, Huang CL, Wang XW, Xu JH, Wu LH, Zhang LY, Tan WQ. The Effectiveness of Topical Anti-scarring Agents and a Novel Combined Process on Cutaneous Scar Management. Curr Pharm Des. 2017;23(15):2268-2275. doi: 10.2174/1381612822666161025144434.
PubMed 27784253Khan MA, Bashir MM, Khan FA. Intralesional triamcinolone alone and in combination with 5-fluorouracil for the treatment of keloid and hypertrophic scars. J Pak Med Assoc. 2014 Sep;64(9):1003-7.
PubMed 25823177Darougheh A, Asilian A, Shariati F. Intralesional triamcinolone alone or in combination with 5-fluorouracil for the treatment of keloid and hypertrophic scars. Clin Exp Dermatol. 2009 Mar;34(2):219-23. doi: 10.1111/j.1365-2230.2007.02631.x. Epub 2008 Nov 6.
PubMed 19018794Huang L, Cai YJ, Lung I, Leung BC, Burd A. A study of the combination of triamcinolone and 5-fluorouracil in modulating keloid fibroblasts in vitro. J Plast Reconstr Aesthet Surg. 2013 Sep;66(9):e251-9. doi: 10.1016/j.bjps.2013.06.004. Epub 2013 Jun 28.
PubMed 23810214Pomerantz H, Hogan D, Eilers D, Swetter SM, Chen SC, Jacob SE, Warshaw EM, Stricklin G, Dellavalle RP, Sidhu-Malik N, Konnikov N, Werth VP, Keri J, Lew R, Weinstock MA; Veterans Affairs Keratinocyte Carcinoma Chemoprevention (VAKCC) Trial Group. Long-term Efficacy of Topical Fluorouracil Cream, 5%, for Treating Actinic Keratosis: A Randomized Clinical Trial. JAMA Dermatol. 2015 Sep;151(9):952-60. doi: 10.1001/jamadermatol.2015.0502.
PubMed 25950503Jones CD, Guiot L, Samy M, Gorman M, Tehrani H. The Use of Chemotherapeutics for the Treatment of Keloid Scars. Dermatol Reports. 2015 May 21;7(2):5880. doi: 10.4081/dr.2015.5880. eCollection 2015 May 21.
PubMed 26236447
Study at a glance
From the registry record, last updated by the sponsor on 26 Jul 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Role of 5-Fluorouracil in Post-Operative Scar Formation Following Direct Brow Ptosis Repair
- ClinicalTrials.gov ID
- NCT03219580
- Acronym / sponsor ID
- LSUIRB#9586
- Conditions
- Brow Ptosis, Facial Scarring
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- Eyelid and Facial ConsultantsUniversity, hospital or other
- Collaborators
- Ochsner Health System
- Study start
- 20 May 2017 (actual)
- Primary completion
- 30 Apr 2020 (estimated)
- Study completion
- 1 Aug 2020 (estimated)
- First posted
- 17 Jul 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.
This is a double (physician and patient) blinded randomized controlled clinical trial in which patients who have undergone bilateral direct brow ptosis repair undergo a trial in which one of brow is injected with placebo 0.9% Normal Saline and the contra-lateral brow is injected with 0.3-0.6 mL over the entire brow of 50mg/mL 5-Fluorouracil sub-dermal injections. The researchers aim to investigate whether injecting 5-Fluorouracil preemptively will not only accelerate wound healing and decrease hypertrophic scar formation compared to placebo, but also improve overall scar appearance in a safe manner.
Detailed description
In this double-blinded (physician and patient) randomized controlled clinical trial, the patient's left and right brows are randomized to either the placebo or treatment arm of the study and maintain this designation for the entirety of the study. This randomization is performed and recorded by the study nurse in the physician's office. This study nurse also will be responsible for preparing the placebo 0.9% Normal Saline (0.9%NS) and the 50mg/mL 5-Fluorouracil (5-FU). Both placebo and 5-FU are placed into identical syringes with 30 gauge needles, both materials are identical in color and clarity, making it impossible for physician or patient to correctly identify which injection is which without a label. Only the study nurse will be aware of which injection is which, and the nurse will ensure that the correct injection is placed into the correct brow at each visit via the study log that the nurse maintains.
A patient who has undergone bilateral direct brow ptosis repair who has agreed to participate in the study will first return for the post-operative day 10 visit where sutures are removed from the brow incisions. The patient returns on post-operative week three for their first injections, the details of which are below:
Starting on post-operative week three, the patient will receive 0.05mL aliquots of each injection (0.9%NS and 5-FU) sub-dermally into the brow incision spread out evenly over the brow, totaling 0.3-0.6 mL of each injection over each respective brow. Photos of the patient's brows will be taken, and then both the physician and patient will fill out a survey recording their impressions, the contents of which are listed in subsequent sections of this protocol. This same procedure will be repeated every three weeks for a total of up to four rounds of injections, thus the final round of injections will be given on post-operative week twelve. At each of these post-operative visits, incidence of any side effects is recorded, and if an unacceptably high rate of side effects occurs, the study will be precociously terminated.
At post-operative week fifteen, the blind is broken, and again photos are taken and physician and patient impressions are recorded via survey. After the blind is broken, if desired, the patient can opt to undergo a similar series of injections on the placebo arm of 5-FU.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
- Model description
- Patients who undergo bilateral direct brow ptosis repair will be randomized to have one brow as the placebo arm and one arm as the active treatment arm. This original randomization will be maintained throughout the study.
| Arm | Type | Receives |
|---|---|---|
| 5-Fluorouracil Active Treatment Arm | Active comparator | Drug: 5-FluorouracilA patient who has undergone bilateral direct brow ptosis repair and has elected to participate in the study will first have each of their brows randomized to either be the active treatment arm or the placebo arm. The active treatment arm brow will be injected with 0.05ml of 5-Fluorouracil 50mg/ml in several injections evenly spaced over the brow incision for a total of 0.3-0.6ml, repeated every three weeks for a total of 4 series of injections. |
| Placebo Arm | Placebo comparator | Drug: Normal Saline Flush, 0.9% Injectable SolutionA patient who has undergone bilateral direct brow ptosis repair and has elected to participate in the study will first have each of their brows randomized to either be the active treatment arm or the placebo arm. The placebo arm brow will be injected with 0.05ml of 0.9% Normal Saline in several injections evenly spaced over the brow incision for a total of 0.3-0.6ml, repeated every three weeks for a total of 4 series of injections. |
Who may qualify
- Ages
- 40 to 90 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Patients who have undergone bilateral direct brow ptosis repair (either cosmetic of functional)
Key exclusion criteria (7 listed)
- Known prior knowledge of the study's existence
- History of hypertrophic scarring
- Prior brow surgery, prior incisions or trauma to the forehead, brow or peri-ocular area in the past
- Patients who are decisionally or mentally impaired as they will be required to fill out the supplied survey and have the capacity for consent for the treatment
- Patients with any disease which may affect the brow (e.g. Myasthenia Gravis)
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 |
|---|---|---|
| 5-Fluorouracil50mg/ml concentration of 5-Fluorouracil to be injected intra-dermally in direct brow skin incisions | Drug | 5-Fluorouracil Active Treatment Arm |
| Normal Saline Flush, 0.9% Injectable Solution0.9% concentration of Normal Saline Injectable Solution to be injected intra-dermally in direct brow skin incisions | Drug | Placebo Arm |
Primary outcome
Overall appearance
Time frame: 1 year
Patient and physician impression of overall appearance of the direct brow incision scar
Skin tone match
Time frame: 1 year
Patient and physician impression of how close the direct brow incision scar matches the patient's natural skin tone/color
Scar roughness/tough to touch
Time frame: 1 year
Patient and physician impression as to the degree of rough to the touch (ie fibrosis) is present in the direct brow incision scar
Scar is flush with eyebrow
Time frame: 1 year
Patient and physician impressions as to degree that direct brow incision scar is flush with skin of the brow
1 secondary outcome
Incidence of side effects
Time frame: 1 year
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Jul 2018.
- Background: PubMed 12920208Wendling J, Marchand A, Mauviel A, Verrecchia F. 5-fluorouracil blocks transforming growth factor-beta-induced alpha 2 type I collagen gene (COL1A2) expression in human fibroblasts via c-Jun NH2-terminal kinase/activator protein-1 activation. Mol Pharmacol. 2003 Sep;64(3):707-13. doi: 10.1124/mol.64.3.707.
- Background: PubMed 25025385Yoo DB, Azizzadeh B, Massry GG. Injectable 5-FU with or without added steroid in periorbital skin grafting: initial observations. Ophthalmic Plast Reconstr Surg. 2015 Mar-Apr;31(2):122-6. doi: 10.1097/IOP.0000000000000214.
- Background: PubMed 27119465Poetschke J, Gauglitz GG. Current options for the treatment of pathological scarring. J Dtsch Dermatol Ges. 2016 May;14(5):467-77. doi: 10.1111/ddg.13027.
- Background: PubMed 11937738Gupta S, Kalra A. Efficacy and safety of intralesional 5-fluorouracil in the treatment of keloids. Dermatology. 2002;204(2):130-2. doi: 10.1159/000051830.
- Background: PubMed 15761426Kontochristopoulos G, Stefanaki C, Panagiotopoulos A, Stefanaki K, Argyrakos T, Petridis A, Katsambas A. Intralesional 5-fluorouracil in the treatment of keloids: an open clinical and histopathologic study. J Am Acad Dermatol. 2005 Mar;52(3 Pt 1):474-9. doi: 10.1016/j.jaad.2004.09.018.
- Background: PubMed 27784253Fang QQ, Chen CY, Zhang MX, Huang CL, Wang XW, Xu JH, Wu LH, Zhang LY, Tan WQ. The Effectiveness of Topical Anti-scarring Agents and a Novel Combined Process on Cutaneous Scar Management. Curr Pharm Des. 2017;23(15):2268-2275. doi: 10.2174/1381612822666161025144434.
- Background: PubMed 25823177Khan MA, Bashir MM, Khan FA. Intralesional triamcinolone alone and in combination with 5-fluorouracil for the treatment of keloid and hypertrophic scars. J Pak Med Assoc. 2014 Sep;64(9):1003-7.
- Background: PubMed 19018794Darougheh A, Asilian A, Shariati F. Intralesional triamcinolone alone or in combination with 5-fluorouracil for the treatment of keloid and hypertrophic scars. Clin Exp Dermatol. 2009 Mar;34(2):219-23. doi: 10.1111/j.1365-2230.2007.02631.x. Epub 2008 Nov 6.
- Background: PubMed 23810214Huang L, Cai YJ, Lung I, Leung BC, Burd A. A study of the combination of triamcinolone and 5-fluorouracil in modulating keloid fibroblasts in vitro. J Plast Reconstr Aesthet Surg. 2013 Sep;66(9):e251-9. doi: 10.1016/j.bjps.2013.06.004. Epub 2013 Jun 28.
- Background: PubMed 25950503Pomerantz H, Hogan D, Eilers D, Swetter SM, Chen SC, Jacob SE, Warshaw EM, Stricklin G, Dellavalle RP, Sidhu-Malik N, Konnikov N, Werth VP, Keri J, Lew R, Weinstock MA; Veterans Affairs Keratinocyte Carcinoma Chemoprevention (VAKCC) Trial Group. Long-term Efficacy of Topical Fluorouracil Cream, 5%, for Treating Actinic Keratosis: A Randomized Clinical Trial. JAMA Dermatol. 2015 Sep;151(9):952-60. doi: 10.1001/jamadermatol.2015.0502.
- Background: PubMed 26236447Jones CD, Guiot L, Samy M, Gorman M, Tehrani H. The Use of Chemotherapeutics for the Treatment of Keloid Scars. Dermatol Reports. 2015 May 21;7(2):5880. doi: 10.4081/dr.2015.5880. eCollection 2015 May 21.
- Individual participant dataSharing planned: No
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Brow Ptosis, Dermatochalasis
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.
Adham B. al Hariri, M.D. principal investigator
Eyelid and Facial Consultants New Orleans
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing 5-Fluorouracil and Normal Saline Flush, 0.9% Injectable Solution in people with Brow Ptosis and Facial Scarring, run by Eyelid and Facial Consultants at 2 sites in United States.
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 1 inclusion and 7 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 26 Jul 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in United States. 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.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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?
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?
Overall appearance (time frame: 1 year). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03219580, 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 26 Jul 2018.