PhotoagingCNXR-001DNCT05279495
Double-Blind Study Determining the Efficacy of CannaXR in Decreasing UVA Premutagenic and Photoaging Markers
A study testing In a double-blinded fashion, 250 mg CANNAXR cream in people with Photoaging, run by MINO Labs, LLC at 1 site in United States.
Trial summary
Ultraviolet light A (UVA) causes oxidization of guanine to mutagenic 8-Oxoguanine (8-OxoG) and the most frequent and best characterized mutation in mitochondrial DNA (mtDNA), a deletion of 4,977 base pairs, called the "common deletion", a marker of photoaging. Read more about this study
- Who is it for?
- Ages 22 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Photoaging
- What is being tested?
- In a double-blinded fashion, 250 mg CANNAXR cream
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 1 siteUnited States
- Study dates
- 15 Jan 2023to 15 May 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 22 to 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Healthy subjects
- 22-65 years of age
- Fitzpatrick skin types II and III
Who cannot join
- Pregnancy
- Personal history of skin cancer
- History of abnormal photosensitivity
- Tobacco smoker
- History or being exposed to other forms of radiation (other than sunlight)
- Using any drug/medication that might alter the response of skin to UVA irradiation
Show all 9Show fewer
- Unable to undergo skin biopsies
- History of abnormal scarring
- History of exposure to the treated areas with external beam X-ray or non-solar UV light irradiation
Trial locations and contacts
1 site in 1 country.
United States1 site
Center for Clinical and Cosmetic Research
Aventura, Florida, 33180
About this study
Ultraviolet light A (UVA) causes oxidization of guanine to mutagenic 8-Oxoguanine (8-OxoG) and the most frequent and best characterized mutation in mitochondrial DNA (mtDNA), a deletion of 4,977 base pairs, called the "common deletion", a marker of photoaging.
Read the detailed description
Evaluations \& Schedule:
Clinical phase:
The study of each subject will last 4-5 weeks, with 7 visits (Screening visit 1, Baseline visit 2, Follow up visit 3, Follow up visit 4, Follow up visit 5 and Follow up/Final Visit 6).
Screening Visit:
Subjects will read and be explained the informed consent. Subjects who agree to participate will sign the informed consent and a copy will be given to them. Exclusion/inclusion criteria will be reviewed.
Subjects will be informed that the left arm will be photographed at visits 1 and 3 and both hip/buttock areas at each visit. A urine pregnancy test will be done on baseline (Visit 1, day 0) and final visit 6.
Visit 2, Baseline (day 0):
Baseline visit will be done no more than 21 days after the screening visit and may be done on the same day as the screening visit. Each subject will be instructed not to change any of his/her photoprotection practices during the duration of the study, including time spent outdoors each weekday and weekend day, with special attention between the hours of 10 AM and 4PM, and sunscreen use and parts of their body where they apply it.
The subject's left volar forearm will be exposed to 10, 15, 20, 25, 30, and 35 J/cm2 doses of ultraviolet A light, through a UVA opaque fenestrated adhesive patch placed, 2 cm distally from antecubital fossa. Appropriate UVA opaque shields will be used to protect surrounding untreated areas.
In double-blinded fashion, subjects will receive sufficient CANNAXR (extended release) cream (CANNAXR pods filled with CBD) and VEHICLE cream (cream with empty CANNAXR pods without CBD) in pump containers, marked right or left, with detailed application instructions and a template for each cream to be applied to specified 50 cm2 areas of either the left and right, hip/buttock skin daily in the morning and evening for 2 weeks, starting the next morning.
Visit 3 (Day 1):
MED-A (minimal erythema dose for UVA) will be determined by evaluating skin exposed the prior day to the different UVA doses. MED-A will be defined as the dose that produced "just perceptible erythema".
Visit 4 (Day 14) Subjects will be asked about adverse events (predicted or unpredicted, local or systemic) since the last visit. Within the treated areas of the right and left hip/buttock, skin will be treated through fenestrated adhesive UVA-opaque patches as follows: Window #1- no UVA dose, and Window #2 - 3x the subjects UVA-MED (determined on Day 1).
Visit 5 (Day 15):
Subjects will be asked about adverse events (predicted or unpredicted, local or systemic) since the last visit. Local anesthesia (lidocaine 2% with epinephrine) will be injected and a 4mm punch biopsy will be performed of the skin of each hip/buttock within the templated Windows #1 and #2, as well as at a site 10 cm from the treated area of the left hip/buttock. One or two 5-0 sutures will be placed to appose the skin edges at each of the biopsied sites. Skin biopsy specimens will be divided in half and placed in labelled containers containing appropriate media for 8-oxo-dG (8-oxo deoxyguanosine), common deletion, histochemical and immunochemical studies. Specimens will be shipped to Dr. Adam Friedman for analyses.
Supplies and wound care instructions will be given.
Visit 6, Final (Day 22-30):
Subjects will be asked about adverse events (predicted or unpredicted, local or systemic) since the last visit and all sutures placed at Visit 5 will be removed. A urine pregnancy test will be done.
Notes:
- If an erythematous response after UVA light exposure is symptomatic (burning and tenderness), subjects will be allowed to use twice a day hydrocortisone 1%, over the counter cream, to treat the area. We will provide the cream at the office.
- Visit 3 has to occur 20-28 hours after baseline visit 2.
- Visit 5 has to occur 20-28 hours after Visit 4.
- Conditions
- Photoaging
- Being tested
- In a double-blinded fashion, 250 mg CANNAXR cream, Topical VEHICLE cream
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
In a double-blinded fashion, 250 mg CANNAXR creamDevice
Also called TOPICAL CBD CANNAXR Cream
Determining the Efficacy of topically applied CANNAXR cream in Decreasing UVA Premutagenic and Photoaging markers 8-oxo-dG and the common deletion. 250 mg TOPICAL CBD CANNAXR Cream will be randomized for application to a delineated 50 cm2 area of either the left or right, hip/buttocks skin twice daily for 2 weeks
Topical VEHICLE creamDevice
Determining the Efficacy of topically applied VEHICLE cream in Decreasing UVA Premutagenic and Photoaging markers 8-oxo-dG and the common deletion. 250 mg VEHICLE cream will be randomized for application to a delineated 50 cm2 area of either the left or right, hip/buttocks skin twice daily for 2 weeks
| Study group | Role | What they receive |
|---|---|---|
| Loaded CANNAXR | Other | In a double-blinded fashion, 250 mg CANNAXR cream and 250 mg VEHICLE cream will be randomized for application to a delineated 50 cm2 area of either the left or right, hip/buttocks skin twice daily for 2 weeks.
In a double-blinded fashion, 250 mg CANNAXR cream and 250 mg VEHICLE cream will be randomized for application to a delineated 50 cm2 area of either the left or right, hip/buttocks skin twice daily for 2 weeks. Receives: Device: In a double-blinded fashion, 250 mg CANNAXR cream; Device: Topical VEHICLE cream |
What is being measured
The primary outcome is the main question the study is designed to answer.
Title: Double-Blind Study to measure and compare the Mean Percent Reduction UVA induced premutagenic and photoaging markers 8-oxo-dG and the common deletion in 20 subjects treated with CANNAXR and Vehicle and exposed to 3X their individual MED-UVA
Determining the Efficacy of topically applied CANNAXR cream vs vehicle cream in decreasing UVA induced Premutagenic and Photoaging markers 8-oxo-dG and the common deletion in 20 subjects exposed to 3X their individual MED-UVA: Comparison of mean percent reduction in UVA induced 8-Oxo-DG and common deletion in CANNAXR and Vehicle treated skin and exposed to 3X MED-UVA
Measured: 2 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Mar 2022
- Study start15 Jan 2023
- Primary completion1 Apr 2023
- Study completion15 May 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (8)Papers the sponsor has linked to this study.
- Other trials for PhotoagingStudies 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
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- Study Design: Prospective, double-blind, vehicle-controlled pilot study
- Masking
- None (open label)
- Enrolment
- 20 participants (actual)
Sponsor and investigators
- Lead sponsor
- MINO Labs, LLC
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05279495
- Sponsor's protocol ID
- CNXR-001D
- Acronym
- CNXR-001D
- Status last verified
- May 2025
- First submitted
- 5 Feb 2022
- Last updated
- 8 May 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Publications
Bruls WA, van Weelden H, van der Leun JC. Transmission of UV-radiation through human epidermal layers as a factor influencing the minimal erythema dose. Photochem Photobiol. 1984 Jan;39(1):63-7. doi: 10.1111/j.1751-1097.1984.tb03405.x. No abstract available.
PubMed 6701210Wondrak GT, Jacobson MK, Jacobson EL. Endogenous UVA-photosensitizers: mediators of skin photodamage and novel targets for skin photoprotection. Photochem Photobiol Sci. 2006 Feb;5(2):215-37. doi: 10.1039/b504573h. Epub 2005 Aug 19.
PubMed 16465308Zhang X, Rosenstein BS, Wang Y, Lebwohl M, Mitchell DM, Wei H. Induction of 8-oxo-7,8-dihydro-2'-deoxyguanosine by ultraviolet radiation in calf thymus DNA and HeLa cells. Photochem Photobiol. 1997 Jan;65(1):119-24. doi: 10.1111/j.1751-1097.1997.tb01886.x.
PubMed 90662914. Appendix A. HW Lim, H Honigsmann, and JLM Hawk In Photodermatology, 2007. Informa Healthcare USA, INC. 443-445.
Yarborough A, Zhang YJ, Hsu TM, Santella RM. Immunoperoxidase detection of 8-hydroxydeoxyguanosine in aflatoxin B1-treated rat liver and human oral mucosal cells. Cancer Res. 1996 Feb 15;56(4):683-8.
PubMed 8630995Agar NS, Halliday GM, Barnetson RS, Ananthaswamy HN, Wheeler M, Jones AM. The basal layer in human squamous tumors harbors more UVA than UVB fingerprint mutations: a role for UVA in human skin carcinogenesis. Proc Natl Acad Sci U S A. 2004 Apr 6;101(14):4954-9. doi: 10.1073/pnas.0401141101. Epub 2004 Mar 23.
PubMed 15041750Berneburg M, Gattermann N, Stege H, Grewe M, Vogelsang K, Ruzicka T, Krutmann J. Chronically ultraviolet-exposed human skin shows a higher mutation frequency of mitochondrial DNA as compared to unexposed skin and the hematopoietic system. Photochem Photobiol. 1997 Aug;66(2):271-5. doi: 10.1111/j.1751-1097.1997.tb08654.x.
PubMed 9277148McCormick E, Han H, Abdel Azim S, Whiting C, Bhamidipati N, Kiss A, Efimova T, Berman B, Friedman A. Topical nanoencapsulated cannabidiol cream as an innovative strategy combating UV-A-induced nuclear and mitochondrial DNA injury: A pilot randomized clinical study. J Am Acad Dermatol. 2024 Nov;91(5):855-862. doi: 10.1016/j.jaad.2024.06.088. Epub 2024 Jul 25.
PubMed 39025264
Study at a glance
From the registry record, last updated by the sponsor on 8 May 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Double-Blind Study Determining the Efficacy of CannaXR in Decreasing UVA Premutagenic and Photoaging Markers
- ClinicalTrials.gov ID
- NCT05279495
- Acronym / sponsor ID
- CNXR-001D / CNXR-001D
- Conditions
- Photoaging
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 20 participants (actual)
- Lead sponsor
- MINO Labs, LLCIndustry (pharma, biotech, devices)
- Study start
- 15 Jan 2023 (actual)
- Primary completion
- 1 Apr 2023 (actual)
- Study completion
- 15 May 2023 (actual)
- First posted
- 15 Mar 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.
Ultraviolet light A (UVA) causes oxidization of guanine to mutagenic 8-Oxoguanine (8-OxoG) and the most frequent and best characterized mutation in mitochondrial DNA (mtDNA), a deletion of 4,977 base pairs, called the "common deletion", a marker of photoaging.
Detailed description
Evaluations \& Schedule:
Clinical phase:
The study of each subject will last 4-5 weeks, with 7 visits (Screening visit 1, Baseline visit 2, Follow up visit 3, Follow up visit 4, Follow up visit 5 and Follow up/Final Visit 6).
Screening Visit:
Subjects will read and be explained the informed consent. Subjects who agree to participate will sign the informed consent and a copy will be given to them. Exclusion/inclusion criteria will be reviewed.
Subjects will be informed that the left arm will be photographed at visits 1 and 3 and both hip/buttock areas at each visit. A urine pregnancy test will be done on baseline (Visit 1, day 0) and final visit 6.
Visit 2, Baseline (day 0):
Baseline visit will be done no more than 21 days after the screening visit and may be done on the same day as the screening visit. Each subject will be instructed not to change any of his/her photoprotection practices during the duration of the study, including time spent outdoors each weekday and weekend day, with special attention between the hours of 10 AM and 4PM, and sunscreen use and parts of their body where they apply it.
The subject's left volar forearm will be exposed to 10, 15, 20, 25, 30, and 35 J/cm2 doses of ultraviolet A light, through a UVA opaque fenestrated adhesive patch placed, 2 cm distally from antecubital fossa. Appropriate UVA opaque shields will be used to protect surrounding untreated areas.
In double-blinded fashion, subjects will receive sufficient CANNAXR (extended release) cream (CANNAXR pods filled with CBD) and VEHICLE cream (cream with empty CANNAXR pods without CBD) in pump containers, marked right or left, with detailed application instructions and a template for each cream to be applied to specified 50 cm2 areas of either the left and right, hip/buttock skin daily in the morning and evening for 2 weeks, starting the next morning.
Visit 3 (Day 1):
MED-A (minimal erythema dose for UVA) will be determined by evaluating skin exposed the prior day to the different UVA doses. MED-A will be defined as the dose that produced "just perceptible erythema".
Visit 4 (Day 14) Subjects will be asked about adverse events (predicted or unpredicted, local or systemic) since the last visit. Within the treated areas of the right and left hip/buttock, skin will be treated through fenestrated adhesive UVA-opaque patches as follows: Window #1- no UVA dose, and Window #2 - 3x the subjects UVA-MED (determined on Day 1).
Visit 5 (Day 15):
Subjects will be asked about adverse events (predicted or unpredicted, local or systemic) since the last visit. Local anesthesia (lidocaine 2% with epinephrine) will be injected and a 4mm punch biopsy will be performed of the skin of each hip/buttock within the templated Windows #1 and #2, as well as at a site 10 cm from the treated area of the left hip/buttock. One or two 5-0 sutures will be placed to appose the skin edges at each of the biopsied sites. Skin biopsy specimens will be divided in half and placed in labelled containers containing appropriate media for 8-oxo-dG (8-oxo deoxyguanosine), common deletion, histochemical and immunochemical studies. Specimens will be shipped to Dr. Adam Friedman for analyses.
Supplies and wound care instructions will be given.
Visit 6, Final (Day 22-30):
Subjects will be asked about adverse events (predicted or unpredicted, local or systemic) since the last visit and all sutures placed at Visit 5 will be removed. A urine pregnancy test will be done.
Notes:
- If an erythematous response after UVA light exposure is symptomatic (burning and tenderness), subjects will be allowed to use twice a day hydrocortisone 1%, over the counter cream, to treat the area. We will provide the cream at the office.
- Visit 3 has to occur 20-28 hours after baseline visit 2.
- Visit 5 has to occur 20-28 hours after Visit 4.
Study design
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- Study Design: Prospective, double-blind, vehicle-controlled pilot study
| Arm | Type | Receives |
|---|---|---|
| Loaded CANNAXR | Other | Device: In a double-blinded fashion, 250 mg CANNAXR cream, Device: Topical VEHICLE creamIn a double-blinded fashion, 250 mg CANNAXR cream and 250 mg VEHICLE cream will be randomized for application to a delineated 50 cm2 area of either the left or right, hip/buttocks skin twice daily for 2 weeks. In a double-blinded fashion, 250 mg CANNAXR cream and 250 mg VEHICLE cream will be randomized for application to a delineated 50 cm2 area of either the left or right, hip/buttocks skin twice daily for 2 weeks. |
Who may qualify
- Ages
- 22 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Healthy subjects
- 22-65 years of age
- Fitzpatrick skin types II and III
Key exclusion criteria (9 listed)
- Pregnancy
- Personal history of skin cancer
- History of abnormal photosensitivity
- Tobacco smoker
- History or being exposed to other forms of radiation (other than sunlight)
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 |
|---|---|---|
| In a double-blinded fashion, 250 mg CANNAXR creamAlso: TOPICAL CBD CANNAXR CreamDetermining the Efficacy of topically applied CANNAXR cream in Decreasing UVA Premutagenic and Photoaging markers 8-oxo-dG and the common deletion. 250 mg TOPICAL CBD CANNAXR Cream will be randomized for application to a delineated 50 cm2 area of either the left or right, hip/buttocks skin twice daily for 2 weeks | Device | Loaded CANNAXR |
| Topical VEHICLE creamDetermining the Efficacy of topically applied VEHICLE cream in Decreasing UVA Premutagenic and Photoaging markers 8-oxo-dG and the common deletion. 250 mg VEHICLE cream will be randomized for application to a delineated 50 cm2 area of either the left or right, hip/buttocks skin twice daily for 2 weeks | Device | Loaded CANNAXR |
Primary outcome
Title: Double-Blind Study to measure and compare the Mean Percent Reduction UVA induced premutagenic and photoaging markers 8-oxo-dG and the common deletion in 20 subjects treated with CANNAXR and Vehicle and exposed to 3X their individual MED-UVA
Time frame: 2 weeks
Determining the Efficacy of topically applied CANNAXR cream vs vehicle cream in decreasing UVA induced Premutagenic and Photoaging markers 8-oxo-dG and the common deletion in 20 subjects exposed to 3X their individual MED-UVA: Comparison of mean percent reduction in UVA induced 8-Oxo-DG and common deletion in CANNAXR and Vehicle treated skin and exposed to 3X MED-UVA
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 8 May 2025.
- Background: PubMed 6701210Bruls WA, van Weelden H, van der Leun JC. Transmission of UV-radiation through human epidermal layers as a factor influencing the minimal erythema dose. Photochem Photobiol. 1984 Jan;39(1):63-7. doi: 10.1111/j.1751-1097.1984.tb03405.x. No abstract available.
- Background: PubMed 16465308Wondrak GT, Jacobson MK, Jacobson EL. Endogenous UVA-photosensitizers: mediators of skin photodamage and novel targets for skin photoprotection. Photochem Photobiol Sci. 2006 Feb;5(2):215-37. doi: 10.1039/b504573h. Epub 2005 Aug 19.
- Background: PubMed 9066291Zhang X, Rosenstein BS, Wang Y, Lebwohl M, Mitchell DM, Wei H. Induction of 8-oxo-7,8-dihydro-2'-deoxyguanosine by ultraviolet radiation in calf thymus DNA and HeLa cells. Photochem Photobiol. 1997 Jan;65(1):119-24. doi: 10.1111/j.1751-1097.1997.tb01886.x.
- Background4. Appendix A. HW Lim, H Honigsmann, and JLM Hawk In Photodermatology, 2007. Informa Healthcare USA, INC. 443-445.
- Background: PubMed 8630995Yarborough A, Zhang YJ, Hsu TM, Santella RM. Immunoperoxidase detection of 8-hydroxydeoxyguanosine in aflatoxin B1-treated rat liver and human oral mucosal cells. Cancer Res. 1996 Feb 15;56(4):683-8.
- Background: PubMed 15041750Agar NS, Halliday GM, Barnetson RS, Ananthaswamy HN, Wheeler M, Jones AM. The basal layer in human squamous tumors harbors more UVA than UVB fingerprint mutations: a role for UVA in human skin carcinogenesis. Proc Natl Acad Sci U S A. 2004 Apr 6;101(14):4954-9. doi: 10.1073/pnas.0401141101. Epub 2004 Mar 23.
- Background: PubMed 9277148Berneburg M, Gattermann N, Stege H, Grewe M, Vogelsang K, Ruzicka T, Krutmann J. Chronically ultraviolet-exposed human skin shows a higher mutation frequency of mitochondrial DNA as compared to unexposed skin and the hematopoietic system. Photochem Photobiol. 1997 Aug;66(2):271-5. doi: 10.1111/j.1751-1097.1997.tb08654.x.
- Derived from this study: PubMed 39025264McCormick E, Han H, Abdel Azim S, Whiting C, Bhamidipati N, Kiss A, Efimova T, Berman B, Friedman A. Topical nanoencapsulated cannabidiol cream as an innovative strategy combating UV-A-induced nuclear and mitochondrial DNA injury: A pilot randomized clinical study. J Am Acad Dermatol. 2024 Nov;91(5):855-862. doi: 10.1016/j.jaad.2024.06.088. Epub 2024 Jul 25.
- 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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing In a double-blinded fashion, 250 mg CANNAXR cream in people with Photoaging, run by MINO Labs, LLC at 1 site 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 3 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: finished, as of the sponsor's last update on 8 May 2025. 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 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. 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?
Title: Double-Blind Study to measure and compare the Mean Percent Reduction UVA induced premutagenic and photoaging markers 8-oxo-dG and the common deletion in 20 subjects treated with CANNAXR and Vehicle and exposed to 3X their individual MED-UVA (time frame: 2 weeks). 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 NCT05279495, which also lists 8 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 8 May 2025.