PsoriasisLITENCT03726489
Light Treatment Effectiveness (LITE) Study
A study testing Daavlin 7 series 3 panel narrow band phototherapy home units and narrow band phototherapy clinic units in people with Psoriasis and Psoriatic Plaque, run by University of Pennsylvania at 38 sites in United States.
Trial summary
To compare the effectiveness, safety (tolerability), and duration of treatment response at 12 weeks of home versus office-based narrowband ultraviolet B phototherapy for the treatment of psoriasis Read more about this study
- Who is it for?
- Ages 12 years and older
- Conditions the study is for
- Psoriasis, Psoriatic Plaque
- What is being tested?
- Daavlin 7 series 3 panel narrow band phototherapy home units and narrow band phototherapy clinic units
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 783 participants
- Where
- 38 sitesUnited States
- Study dates
- 1 Mar 2019to 30 Dec 2023
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 12 years and older
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Willing and able to provide informed consent (age 18+) or parental permission and assent (ages 12-17)
- Age 12 or older
- Plaque or guttate psoriasis predominantly located on trunk and/or extremities, with a physician global assessment average of >1.0, and considered a candidate for phototherapy
- Patient is deemed willing and able to comply with either in-office or in-home phototherapy:
- In office: Able to travel about 3 times per week for 12 weeks from home, work and/or school during business hours of local site
- In home: Has space to accommodate home phototherapy unit and patient (or if 12-17, parent), willing and able to follow home phototherapy instructions
- New or established patient in the practice
Who cannot join
- Patients who are judged unable or unwilling to comply with either in office or in home phototherapy due to time, work, school, or other financial constraints
- Patients judged unable to follow home phototherapy protocol due to failure to demonstrate understanding of the following:
- How to operate the phototherapy device
- How to follow the dosing protocol
- Requirement to wear protective eyewear and genital protection equipment
- Patients with known history of lack of efficacy to phototherapy or treated with phototherapy 14 days prior to baseline visit
Show all 13Show fewer
- Psoriasis predominantly located on scalp, body folds, genitals, palms and/or soles or with a physician global assessment average of ≤ 1.0
- Patients deemed unsafe to be treated with phototherapy:
- History of photosensitivity or autoimmune disease such as lupus or dermatomyositis which can be aggravated by ultraviolet radiation
- History of arsenic intake
- Unable to tolerate standing for required duration of treatment due to age or physical function
- History of melanoma or multiple non-melanoma skin cancers that in the opinion of the principal investigator contraindicates treatment with phototherapy
- Clinical site deems the participant is ineligible for reason other than eligibility or screening criteria.
Trial locations and contacts
38 sites in 1 country.
38 sites in 1 country
United States38 sites
University of New Mexico
Albuquerque, New Mexico, 87102
Johns Hopkins University
Baltimore, Maryland, 21287
Total Skin & Beauty Dermatology Center
Birmingham, Alabama, 35205
Brigham and Women's Hospital
Boston, Massachusetts, 02115
Dermatology Specialist of Brighton
Brighton, Michigan, 48114
HHC Kings County Hospital
Brooklyn, New York, 10013
SUNY Downstate Health Sciences University
Brooklyn, New York, 11203
Buffalo Medical Group
Buffalo, New York, 14221
University of Vermont & State Agriculture College
Burlington, Vermont, 05405
University of Virginia
Charlottesville, Virginia, 22908
Northwestern University
Chicago, Illinois, 60611
Ohio State University
Columbus, Ohio, 43215
Dermatology Treatment and Research Center
Dallas, Texas, 75230
Menter Dermatology Research Institute
Dallas, Texas, 75246
Henry Ford Health System
Detroit, Michigan, 48202
Psoriasis Treatment Center of Central New Jersey
East Windsor, New Jersey, 08520
Pennsyvlania Centre For Dermatology
Exton, Pennsylvania, 19341
Johnson Dermatology
Fort Smith, Arkansas, 72916
West Houston Dermatology
Houston, Texas, 77082
Dawes Fretzin Clinical Research
Indianapolis, Indiana, 46256
University of Southern California
Los Angeles, California, 90033
University of Wisconsin
Madison, Wisconsin, 53715
Heymann, Manders, Green, and Sommer, LLC
Marlton, New Jersey, 08053
Frontier Derm Partners CRO, LLC
Mill Creek, Washington, 98012
MD Claiborne and Associates, LLC
New Orleans, Louisiana, 70115
University of Pennsylvania
Philadelphia, Pennsylvania, 19104
Temple University
Philadelphia, Pennsylvania, 19122
MaineHealth/Maine Medical Center
Portland, Maine, 04102
Infinity Dermatology NYC
Queens, New York, 11375
University of Utah
Salt Lake City, Utah, 84112
University of California, San Francisco
San Francisco, California, 94143
Mayo Clinic Arizona
Scottsdale, Arizona, 85259
DermAssociates LLC
Silver Spring, Maryland, 20902
Washington University in St. Louis
St Louis, Missouri, 63130
Montefiore Medical Center
The Bronx, New York, 10467
George Washington University
Washington D.C., District of Columbia, 20037
Howard University
Washington D.C., District of Columbia, 20059
Wake Forest University Health Sciences
Winston-Salem, North Carolina, 27157
About this study
Official title: A Pragmatic Trial of Home Versus Office Based Narrow Band Ultraviolet B Phototherapy for the Treatment of Psoriasis
To compare the effectiveness, safety (tolerability), and duration of treatment response at 12 weeks of home versus office-based narrowband ultraviolet B phototherapy for the treatment of psoriasis
Read the detailed description
The primary objective of this study is to compare the effectiveness, safety (tolerability), and duration of treatment response at 12 weeks of home versus office-based narrowband ultraviolet B phototherapy for the treatment of psoriasis. Physician Global Assessment (PGA) and Dermatology Life Quality Index (DLQI) will be used to assess effectiveness, safety (tolerability), and duration of treatment response. This is a three year pragmatic, randomized, active comparator effectiveness study.
- Conditions
- Psoriasis, Psoriatic Plaque
- Being tested
- Daavlin 7 series 3 panel narrow band phototherapy home units, narrow band phototherapy clinic units
- Medical subject headings
- Psoriasis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Daavlin 7 series 3 panel narrow band phototherapy home unitsDevice
Daavlin 7 series 3 panel narrow band phototherapy home units (with 8-12 bulbs and a smaller, flat surface with door, measuring 21" wide, 74.5" tall, and 23.5"). This unit is a class II device with a FDA 510K indication for psoriasis, vitiligo and atopic dermatitis/eczema. The unit will have a dosimetry controller, a UV sensor built in that measures the intensity of the light. This sensor will adjust the treatment time to compensate for any variation in output due to aging of the lamps or other factors
narrow band phototherapy clinic unitsDevice
Office based narrow band phototherapy unit (units typically have at least 24 bulbs in a surround structure
| Study group | Role | What they receive |
|---|---|---|
| Office Based Phototherapy | Other | Patients randomized to this arm will receive narrow band phototherapy in a clinical setting via narrow band phototherapy clinic units. Receives: Device: narrow band phototherapy clinic units |
| Home Based Phototherapy | Active comparator | Patients randomized to this arm will receive narrow band phototherapy in a home setting via Daavlin 7 series 3 panel narrow band phototherapy home units. Receives: Device: Daavlin 7 series 3 panel narrow band phototherapy home units |
What is being measured
The primary outcome is the main question the study is designed to answer.
Physician Global Assessment (PGA) Score of Clear/Almost Clear
Measure of clinical treatment response, with PGA score of 0/1 (clear/almost clear). PGA score range from 0 (clear) to 5 (worst disease state).
Measured: 12 weeks after randomization or earlier at discontinuation of phototherapy
Impact of Dermatological Disease on Quality of Life (DLQI ≤5)
Dermatology Life Quality Index (DLQI) score of ≤5 which corresponds to no to small impact of dermatologic disease on quality of life. DLQI is a 10 item survey that asks patients questions about their health related quality of life on a 0-3 scale. The DLQI is calculated by summing the score of each question resulting in a maximum of 30 and a minimum of 0. The higher the score, the more quality of life is impaired
Measured: 12 weeks after randomization or earlier at discontinuation of phototherapy
Secondary outcomes (14)
Total Number of Phototherapy Treatments Received
patient or site reported phototherapy dosing
Measured: 12 weeks after randomization or earlier at discontinuation of phototherapy
Cumulative Dose of Phototherapy Received
Cumulative dose of photherapy is the sum of all individual doses from randomization to week 12 visit.
Measured: 12 weeks after randomization or earlier at discontinuation of phototherapy
Concomitant Topical Psoriasis Treatment
Patient reported topical psoriasis treatment - number of days per week the patient takes topical medication
Measured: week 12 and week 24 after randomization
Changes in Initiation or Discontinuation of Oral or Biologic Psoriasis Treatments
Measured: week 12 and week 24 after randomization
Patient-reported Time Spent on Phototherapy Per Treatment
patient reported survey
Measured: 12 weeks after randomization or earlier at discontinuation of phototherapy
Patient Reported Costs Associated With Travel for Phototherapy Treatments
patient reported survey for Office patients only
Measured: 12 weeks after randomization or earlier at discontinuation of phototherapy
Patient Reported Time Associated With Travel for Phototherapy Treatments
patient reported survey for Office patients only
Measured: 12 weeks after randomization or earlier at discontinuation of phototherapy
DLQI (0-1)
Dermatology Life Quality Index (DLQI) score of ≤1 which corresponds to no impact of dermatologic disease on quality of life. DLQI is a 10 item survey that asks patients questions about their health related quality of life on a 0-3 scale. The DLQI is calculated by summing the score of each question resulting in a maximum of 30 and a minimum of 0. The higher the score, the more quality of life is impaired
Measured: 12 weeks after randomization or earlier at discontinuation of phototherapy
Achievement of a Minimal Clinically Important Difference (MCID) on the DLQI
A difference of 4 was determined to be the MCID
Measured: 12 weeks after randomization or earlier at discontinuation of phototherapy
Physician Global Assessment Times Body Surface Area (PGAxBSA)
The difference in PGAxBSA from baseline to week 12. Values range from -500 to 500, with negative values indicating improvement in disease.
BSA is a measure of the body surface area affected by psoriasis using the handprint method in which the palm of the entire hand approximates 1% of the body surface area. PGA is previously described. The product of the two measurements (PGA×BSA) has been investigated to assess psoriasis severity, with higher values indicating greater disease burden.
Reference: Chiesa Fuxench et al. Validity of the simple-measure for assessing psoriasis activity (S-MAPA) for objectively evaluating disease severity in patients with plaque psoriasis. J Am Acad Dermatol 2015;73:868-7.
Measured: 12 weeks after randomization or earlier at discontinuation of phototherapy
PGA x BSA 75%
Binary outcome of achieving 75% reduction in PGA x BSA from baseline to week 12
Measured: 12 weeks after randomization or earlier at discontinuation of phototherapy
PGA x BSA 90%
Binary outcome of achieving 90% reduction in PGA x BSA from baseline to week 12
Measured: 12 weeks after randomization or earlier at discontinuation of phototherapy
Duration of Treatment Response During Observation Period
Defined as the length of time from week 12 to the earliest of DLQI > 5 or time of initiation of a new systemic treatment or dose escalation of an existing systemic treatment, with patients who maintain DLQI <=5 5 throughout the 12 week observation period with no new systemic treatments or dose escalation censored at week 24.
Measured: 24 weeks after randomization
Patients Receiving at Least 80% of Treatments
80% of assigned treatments is defined as 24 total treatments. Patients must have at least one treatment to be included.
Measured: 12 weeks after randomization or earlier at discontinuation of phototherapy
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Oct 2018
- Study start1 Mar 2019
- Primary completion31 Oct 2023
- Study completion30 Dec 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for PsoriasisStudies of the same condition, open and under way.
- More trials run by University of PennsylvaniaThe 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
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Pragmatic, randomized, active comparator effectiveness study
- Masking
- None (open label)
- Enrolment
- 783 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Pennsylvania
- Sponsor type
- University, hospital or other
- Collaborators
- University of Utah, National Psoriasis Foundation, Patient-Centered Outcomes Research Institute
- Responsible party
- Sponsor
- Investigators
- Joel M. Gelfand, MD,MSCE, Principal investigator, University of Pennsylvania
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03726489
- Sponsor's protocol ID
- 831323
- Other IDs
- PCS-1608-35830
- Acronym
- LITE
- Status last verified
- Sep 2024
- First submitted
- 29 Oct 2018
- Last updated
- 19 Sep 2024
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
Publications
Gelfand JM, Armstrong AW, Lim HW, Feldman SR, Johnson SM, Claiborne WCC, Kalb RE, Jakus J, Mangold AR, Flowers RH, Bhutani T, Durkin JR, Bagel J, Fretzin S, Sheehan MP, Krell J, Reeder M, Kaffenberger J, Kartono F, Takeshita J, Bridges AM, Fielding E, Nehal US, Schaecher KL, Howard LM, Eakin GS, Baez S, Bishop BE, Fitzsimmons RC Jr, Papadopoulos M, Song WB, Linn KA, Hubbard RA, Shin DB, Callis Duffin K. Home- vs Office-Based Narrowband UV-B Phototherapy for Patients With Psoriasis: The LITE Randomized Clinical Trial. JAMA Dermatol. 2024 Dec 1;160(12):1320-1328. doi: 10.1001/jamadermatol.2024.3897.
PubMed 39319513
Study at a glance
From the registry record, last updated by the sponsor on 19 Sep 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Pragmatic Trial of Home Versus Office Based Narrow Band Ultraviolet B Phototherapy for the Treatment of Psoriasis
- ClinicalTrials.gov ID
- NCT03726489
- Acronym / sponsor ID
- LITE / 831323
- Conditions
- Psoriasis, Psoriatic Plaque
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 783 participants (actual)
- Lead sponsor
- University of PennsylvaniaUniversity, hospital or other
- Collaborators
- University of Utah, National Psoriasis Foundation, Patient-Centered Outcomes Research Institute
- Study start
- 1 Mar 2019 (actual)
- Primary completion
- 31 Oct 2023 (actual)
- Study completion
- 30 Dec 2023 (actual)
- First posted
- 31 Oct 2018 (actual)
- Results
- Posted 19 Sep 2024
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
To compare the effectiveness, safety (tolerability), and duration of treatment response at 12 weeks of home versus office-based narrowband ultraviolet B phototherapy for the treatment of psoriasis
Detailed description
The primary objective of this study is to compare the effectiveness, safety (tolerability), and duration of treatment response at 12 weeks of home versus office-based narrowband ultraviolet B phototherapy for the treatment of psoriasis. Physician Global Assessment (PGA) and Dermatology Life Quality Index (DLQI) will be used to assess effectiveness, safety (tolerability), and duration of treatment response. This is a three year pragmatic, randomized, active comparator effectiveness study.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Pragmatic, randomized, active comparator effectiveness study
| Arm | Type | Receives |
|---|---|---|
| Office Based Phototherapy | Other | Device: narrow band phototherapy clinic unitsPatients randomized to this arm will receive narrow band phototherapy in a clinical setting via narrow band phototherapy clinic units. |
| Home Based Phototherapy | Active comparator | Device: Daavlin 7 series 3 panel narrow band phototherapy home unitsPatients randomized to this arm will receive narrow band phototherapy in a home setting via Daavlin 7 series 3 panel narrow band phototherapy home units. |
Who may qualify
- Ages
- 12 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (7 listed)
- Willing and able to provide informed consent (age 18+) or parental permission and assent (ages 12-17)
- Age 12 or older
- Plaque or guttate psoriasis predominantly located on trunk and/or extremities, with a physician global assessment average of >1.0, and considered a candidate for phototherapy
- Patient is deemed willing and able to comply with either in-office or in-home phototherapy:
- New or established patient in the practice
Key exclusion criteria (13 listed)
- Patients who are judged unable or unwilling to comply with either in office or in home phototherapy due to time, work, school, or other financial constraints
- Patients judged unable to follow home phototherapy protocol due to failure to demonstrate understanding of the following:
- Patients with known history of lack of efficacy to phototherapy or treated with phototherapy 14 days prior to baseline visit
- Psoriasis predominantly located on scalp, body folds, genitals, palms and/or soles or with a physician global assessment average of ≤ 1.0
- Patients deemed unsafe to be treated with phototherapy:
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 |
|---|---|---|
| Daavlin 7 series 3 panel narrow band phototherapy home unitsDaavlin 7 series 3 panel narrow band phototherapy home units (with 8-12 bulbs and a smaller, flat surface with door, measuring 21" wide, 74.5" tall, and 23.5"). This unit is a class II device with a FDA 510K indication for psoriasis, vitiligo and atopic dermatitis/eczema. The unit will have a dosimetry controller, a UV sensor built in that measures the intensity of the light. This sensor will adjust the treatment time to compensate for any variation in output due to aging of the lamps or other factors | Device | Home Based Phototherapy |
| narrow band phototherapy clinic unitsOffice based narrow band phototherapy unit (units typically have at least 24 bulbs in a surround structure | Device | Office Based Phototherapy |
Primary outcome
Physician Global Assessment (PGA) Score of Clear/Almost Clear
Time frame: 12 weeks after randomization or earlier at discontinuation of phototherapy
Measure of clinical treatment response, with PGA score of 0/1 (clear/almost clear). PGA score range from 0 (clear) to 5 (worst disease state).
Impact of Dermatological Disease on Quality of Life (DLQI ≤5)
Time frame: 12 weeks after randomization or earlier at discontinuation of phototherapy
Dermatology Life Quality Index (DLQI) score of ≤5 which corresponds to no to small impact of dermatologic disease on quality of life. DLQI is a 10 item survey that asks patients questions about their health related quality of life on a 0-3 scale. The DLQI is calculated by summing the score of each question resulting in a maximum of 30 and a minimum of 0. The higher the score, the more quality of life is impaired
14 secondary outcomes
Total Number of Phototherapy Treatments Received
Time frame: 12 weeks after randomization or earlier at discontinuation of phototherapy
Cumulative Dose of Phototherapy Received
Time frame: 12 weeks after randomization or earlier at discontinuation of phototherapy
Concomitant Topical Psoriasis Treatment
Time frame: week 12 and week 24 after randomization
Changes in Initiation or Discontinuation of Oral or Biologic Psoriasis Treatments
Time frame: week 12 and week 24 after randomization
Patient-reported Time Spent on Phototherapy Per Treatment
Time frame: 12 weeks after randomization or earlier at discontinuation of phototherapy
Patient Reported Costs Associated With Travel for Phototherapy Treatments
Time frame: 12 weeks after randomization or earlier at discontinuation of phototherapy
Patient Reported Time Associated With Travel for Phototherapy Treatments
Time frame: 12 weeks after randomization or earlier at discontinuation of phototherapy
DLQI (0-1)
Time frame: 12 weeks after randomization or earlier at discontinuation of phototherapy
Achievement of a Minimal Clinically Important Difference (MCID) on the DLQI
Time frame: 12 weeks after randomization or earlier at discontinuation of phototherapy
Physician Global Assessment Times Body Surface Area (PGAxBSA)
Time frame: 12 weeks after randomization or earlier at discontinuation of phototherapy
PGA x BSA 75%
Time frame: 12 weeks after randomization or earlier at discontinuation of phototherapy
PGA x BSA 90%
Time frame: 12 weeks after randomization or earlier at discontinuation of phototherapy
Duration of Treatment Response During Observation Period
Time frame: 24 weeks after randomization
Patients Receiving at Least 80% of Treatments
Time frame: 12 weeks after randomization or earlier at discontinuation of phototherapy
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Sep 2024.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 39319513Gelfand JM, Armstrong AW, Lim HW, Feldman SR, Johnson SM, Claiborne WCC, Kalb RE, Jakus J, Mangold AR, Flowers RH, Bhutani T, Durkin JR, Bagel J, Fretzin S, Sheehan MP, Krell J, Reeder M, Kaffenberger J, Kartono F, Takeshita J, Bridges AM, Fielding E, Nehal US, Schaecher KL, Howard LM, Eakin GS, Baez S, Bishop BE, Fitzsimmons RC Jr, Papadopoulos M, Song WB, Linn KA, Hubbard RA, Shin DB, Callis Duffin K. Home- vs Office-Based Narrowband UV-B Phototherapy for Patients With Psoriasis: The LITE Randomized Clinical Trial. JAMA Dermatol. 2024 Dec 1;160(12):1320-1328. doi: 10.1001/jamadermatol.2024.3897.
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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.
Joel M. Gelfand, MD,MSCE principal investigator
University of Pennsylvania
38 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Daavlin 7 series 3 panel narrow band phototherapy home units and narrow band phototherapy clinic units in people with Psoriasis and Psoriatic Plaque, run by University of Pennsylvania at 38 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 7 inclusion and 13 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 19 Sep 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 38 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. 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?
Yes. Results are posted in the registry (first posted 19 Sep 2024). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Physician Global Assessment (PGA) Score of Clear/Almost Clear (time frame: 12 weeks after randomization or earlier at discontinuation of phototherapy). The study lists 2 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 NCT03726489, which also lists 1 linked publication.
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 19 Sep 2024.