Acne VulgarisPhase 4NCT07524946
Study to Assess Safety, Pharmacokinetics, and Treatment Effect of Cabtreo
A Phase 4 study testing CABTREO is a fixed-combination product of clindamycin phosphate 1.2%/BPO 3.1%/adapalene 0.15%. in people with Acne Vulgaris, run by Bausch Health Americas, Inc. at 15 sites in United States.
Trial summary
This study is to evaluate the safety, pharmacokinetics, and treatment effect for topically applied CABTREO lotion in pediatric participants ages 9 to 11 years, 11 months with Acne Vulgaris. Read more about this study
- Who is it for?
- Ages 9 to 11 years
- Conditions the study is for
- Acne Vulgaris
- What is being tested?
- CABTREO is a fixed-combination product of clindamycin phosphate 1.2%/BPO 3.1%/adapalene 0.15%.
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- 15 sitesUnited States
- Study dates
- 1 Apr 2026to Dec 2027
- Phase
- Phase 4
- Are there results?
- Not yet: the study is under way
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 9 to 11 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- A participant will be eligible for inclusion if he/she meets all the following criteria:
- Male or female participants, ≥ 9 years of age and ≤ 11 years, 11 months of age at baseline
- Participants must provide verbal and signed, written informed consent; participants less than the age of consent must sign an assent for the study and a parent/legal guardian must sign the informed consent
- Participants must have a score of 3 (moderate) or 4 (severe) on the EGSS assessment at baseline
- Participants must have a facial acne inflammatory lesion (papules, pustules, and nodules) count ≥ 30 at baseline
- Participants must have a facial acne noninflammatory lesion (open and closed comedones) count ≥ 35 at baseline
Show all 13Show fewer
- Participants must have acne lesions in at least 1 truncal region (ie, on the chest, back, and/or shoulder) at baseline
- Participants must have ≤ 2 facial nodules at baseline
- Women of childbearing potential and female participants who are premenses (≥ 9 years of age) must be willing to practice effective contraception for the duration of the study.
- Effective contraception is defined as being stabilized on an oral contraceptive for at least 3 months; using an intrauterine device/system, condom with spermicide, diaphragm with spermicide, implant, NuvaRing®, injection, transdermal patch; bilateral tubal ligation; vasectomized partner; or practicing abstinence. Females on birth control pills must have taken the same type of pill for at least 3 months prior to entering the study and must not change types during the study. Those who have used birth control pills in the past must have discontinued use at least 3 months prior to the start of the study. Those who use birth control for acne control only should be excluded.
- Premenses females and women of childbearing potential must have a negative urine pregnancy test at screening and baseline, and must have a negative serum pregnancy test at screening.
- Participants must be willing to comply with study instructions and return to the study center for required visits; participants under the age of consent must be accompanied by the parent/legal guardian at the time of providing assent/consent
- If a cleanser, moisturizer or sunscreen is needed during the study, participants must be willing to use only allowed cleansers, moisturizers, sunscreens, or moisturizer/sunscreen combination products; the participant must agree to use noncomedogenic products (including makeup and shaving products) Use of an investigational drug or device within 30 days of enrollment or participation in a research study concurrent with this study
Who cannot join
- A participant will not be eligible for inclusion if any of the following criteria apply:
- Use of an investigational drug or device within 30 days of enrollment or participation in a research study concurrent with this study
- Any dermatological conditions on the face that could interfere with clinical evaluations such as acne conglobata, acne fulminans, secondary acne, perioral dermatitis, clinically significant rosacea, gram-negative folliculitis, dermatitis, and/or eczema
- Any underlying disease(s) or other dermatological condition of the face that requires the use of interfering topical or systemic therapy, or makes evaluations and lesion counts inconclusive
- Participants with > 2 facial nodules at baseline
- Evidence or history of cosmetic-related acne
Show all 32Show fewer
- Participants with a history of experiencing significant burning or stinging when applying any facial treatment (eg, makeup, soap, masks, washes, sunscreens) to the face
- Female participants who are pregnant, nursing mothers, planning a pregnancy during the course of the study, or become pregnant during the study
- Use of estrogens (eg, Depogen, Depo-Testadiol, Gynogen, Valergen) for less than 12 weeks immediately preceding study entry; a participant who is treated with estrogens for ≥ 12 consecutive weeks immediately prior to study entry need not be excluded unless the participant expects to change the dose, the drug, or discontinue estrogen use during the study
- If female, participant has a history of hirsutism, polycystic ovarian disease, or clinically significant menstrual irregularities
- History of regional enteritis, ulcerative colitis, inflammatory bowel disease, pseudomembranous colitis, chronic or recurrent diarrhea, or antibiotic-associated colitis
- Treatment of any type of cancer within the 6 months prior to screening, with the exception of complete surgical excision of skin cancer outside the treatment area
- Participant uses medications and/or vitamins during the study that are reported to exacerbate acne (azathioprine, haloperidol, Vitamin D, Vitamin B12, halogens such as iodides or bromides, lithium, systemic or topical mid- to super-high potency corticosteroids on the treatment area, phenytoin, and phenobarbital); multivitamins, including Vitamin A, at recommended daily doses, and Vitamin D at stable doses, are acceptable
- History of hypersensitivity or allergic reactions to any of the study preparations as described in the Investigator's Brochure, including known sensitivities to any dosage form of clindamycin phosphate, BPO, or adapalene
- Concomitant use of potentially irritating over the counter products that contain ingredients such as BPO, alpha-hydroxy acid, salicylic acid, retinol, or glycolic acids
- Participants who have not undergone the specified washout period(s) for the following topical preparations or physical treatments used on the face or participants who require the concurrent use of any of the following topical agents in the treatment area:
- Topical astringents and abrasives (including comedo removal strips) on the face -1 week
- Nonallowed moisturizers or sunscreens on the face -1 week
- Antibiotics on the face -2 weeks
- Other topical anti-acne drugs on the face -2 weeks
- Soaps containing antimicrobials on the face -2 weeks
- Anti-inflammatory agents and corticosteroids on the face -4 weeks
- Retinoids, including retinol, on the face -4 weeks
- Facial procedures, including chemical peel, microdermabrasion, light (eg, PDT, LED) and laser therapy, and acne surgery -4 weeks
- Participants who have not undergone the specified washout period(s) for the following systemic medications or participants who require the concurrent use of any of the following systemic medications:
- Corticosteroids (including intramuscular injections) (inhaled corticosteroids allowed) -4 weeks
- Antibiotics -4 weeks
- Other systemic acne treatments -4 weeks
- Systemic retinoids -6 months
- Participants who intend to use a tanning booth or sunbathe during the study
- Participants who are unable to communicate or cooperate with the investigator due to language problems, poor mental development, or impaired cerebral function
- Participants who have any underlying disease the investigator deems uncontrolled, and that poses a concern for the participant's safety while participating in the study
Trial locations and contacts
15 sites in 1 country. Contact the study team or a site near you to ask about taking part.
15 sites in 1 country
United States15 sites, 15 recruiting
- Not yet recruiting
Flourish Research Acquisition, LLC
Apex, North Carolina, 70471
Martha Stewart, MD, 985-900-2400, mstewartmd@clinicaltrialsmgt.com
Sandi Bailey, 985-900-2400, sbailey@flourishresearch.com
- Recruiting
Dermatology Trial Associates
Bryant, Arkansas, 72002
Dow Stough, MD, 501-655-6138, dow@burketherapeutics.com
Makenzie Mixon, 501-655-6138, mmixon@burkepharmaceutical.com
- Recruiting
Michigan Center for Skin Care Research
Clinton Township, Michigan, 48038
Mary Veremis-Ley, MD, 586-286-7325, mveremisley@docsdermgroup.com
Kathleen Gesinski, 586-286-7325, kgesinski@skincareresearch.com
- Recruiting
Center for Dermatology Clinical Research
Freemont, California, 94538
Sunil Dhawan, MD, 510-797-0140, sdhawan@centerforderm.com
Mele Tupou, 510-797-0140, melet@ctr4derm.com
- Recruiting
Cyn3rgy Research Corporation
Gresham, Oregon, 97030
Frank Calcagno, MD, 503-907-2179, fcalcagno@cyn3rgy.com
Danille Frazen, 503-907-2179, dfranzen@cyn3rgy.com
- Recruiting
JDR Dermatology Research
Las Vegas, Nevada, 89145
James Del Rosso, MD, 702-331-4123, jqdelrosso@yahoo.com
Lupe Barrera, 702-331-4123, Gb.drdr@gmail.com
- Recruiting
DS Research of Kentucky, LLC
Louisville, Kentucky, 40241
Cindy Owen, MD, 502-585-9059, cowen@dsrtrials.com
Kaley Kidd, 502-585-9059, kkidd@dsresearch.com
- Recruiting
Ablon Skin Institute and Research Center
Manhattan Beach, California, 90266
Glynis Ablon, MD, 310-727-3376, drablon@abloninstitute.com
Shelley Joyce, 310-727-3376, shelley@abloninstitute.com
- Recruiting
Ziaderm Research, LLC
North Miami Beach, Florida, 33162
Tory Sullivan, MD, 305-652-8600, drtory@sullivandermatology.com
Daine Velazco, MD, 305-652-8600, daine@sullivandermatology.com
- Recruiting
Lynn Health Science Institute
Oklahoma City, Oklahoma, 73112
Carl Griffin, MD, 405-602-3927, Cgriffin@lhsi.net
Dalia Tover, 405-602-3927, Dtovar@lhsi.net
- Recruiting
Northwest Arkansas Clinical Trials Center
Rogers, Arkansas, 72758
Cheryl Hull, MD, 479-876-8205, drhull@hullderm.com
Olympia Marshall, 479-876-8205, omarshall@hullderm.com
- Recruiting
Breakaway Research Group
Spokane, Washington, 99202
William Werschler, MD, 509-343-3710, Werschler@breakaway-research.com
Payton Heid, 509-343-3710, Pheid@breakaway-research.com
- Recruiting
DermResearchCenter of New York
Stony Brook, New York, 11790
Elyse Rafal, MD, 631-689-1900, erafal@dcny.com
Carolyn Thanasoulis, 631-689-1900, cthanasoulis@drcny.com
- Recruiting
Clinical Research Trials of Florida, Inc
Tampa, Florida, 33607
Sady Alpizar, MD, 813-873-8102, s.alpizar.md@crtfi.com
Viviana Fonseca, 813-873-8102, viviana@crtfi.com
- Recruiting
Vitality Clinical Trials, LLC
Woodbury, New York, 11797
Jeffrey Sklar, MD, 917-647-3830, jeffrey.sklar@vitalityclinicaltrials.com
Melody Dalessandro, 917-647-3830, melody.dalessandro@vitalityclinicaltrials.com
About this study
Official title: A 12-Week, Phase 4, Open-Label Study To Assess Safety, Pharmacokinetics, and Treatment Effect of CABTREO (Clindamycin Phosphate 1.2%, Adapalene 0.15%, and Benzoyl Peroxide 3.1%) Topical Gel In Pediatric Participants Ages 9 to 11 Years, 11 Month With Acne Vulgaris
This study is to evaluate the safety, pharmacokinetics, and treatment effect for topically applied CABTREO lotion in pediatric participants ages 9 to 11 years, 11 months with Acne Vulgaris.
Read the detailed description
This is an open-label study designed to assess the safety, plasma PK, and treatment effect of topically applied CABTREO. This study includes both a main study and a PK sub-study. All participants will undergo a screening period of up to 5 weeks (up to 35 days) and a treatment period of up to 12 weeks (approximately 84 days). A subset of participants in the main study will be included in the PK sub-study. To be eligible for this study, participants must be between 9 years and 11 years, 11 months of age, inclusive, and have a clinical diagnosis of moderate to severe acne, defined as a score of 3 (moderate) or 4 (severe) on the Evaluator's Global Severity Score (EGSS). Participants must also have at least 30 facial acne inflammatory lesions, at least 35 facial acne noninflammatory lesions, and no more than 2 facial nodules; participants should also have acne lesions on at least 1 region of the trunk (chest, back, and/or shoulder).
- Conditions
- Acne Vulgaris
- Being tested
- CABTREO is a fixed-combination product of clindamycin phosphate 1.2%/BPO 3.1%/adapalene 0.15%.
- Keywords
- Pediatric, Open-Label, Cabtreo, Acne Vulgaris, Topical
- Medical subject headings
- Acne Vulgaris
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CABTREO is a fixed-combination product of clindamycin phosphate 1.2%/BPO 3.1%/adapalene 0.15%.Drug
Also called IDP-126
The study drug will be applied topically to the treatment areas at home, each the morning, for a period of 12 weeks, with the exception of study visit days (baseline [Day 1], and Days 14, 15 [PK substudy only], 28, 29 [PK substudy only], 56, and 84) where study drug will be applied by the participants after the study visit is completed at the study center. The study drug will be applied as a thin coating that is gently rubbed into the skin.
| Study group | Role | What they receive |
|---|---|---|
| All enrolled participants will receive CABTREO in this open-label study. | Other | CABTREO is a fixed-combination product of clindamycin phosphate 1.2%/BPO 3.1%/adapalene 0.15%. Receives: Drug: CABTREO is a fixed-combination product of clindamycin phosphate 1.2%/BPO 3.1%/adapalene 0.15%. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence of Treatment-Emergent Adverse Events
Starting after signing the informed consent/assent document, and continuing through the end of the study, participants will be assessed for the occurrence of new AEs and changes in ongoing AEs. The descriptions of all AEs will include the dates of onset and resolution (if resolved), maximum severity, seriousness, action taken regarding the study drug, corrective treatment, outcome, and the investigator's assessment of causality. Worsening of disease will not be considered an AE unless it results in discontinuation of the participant from the study or requires medical intervention prohibited by the protocol. All AEs will be followed to resolution or until stable, as determined by the investigator.
Measured: All AEs will be followed from onset of the adverse event through the end of Study Week 12 visit
Change in Inflammatory Lesions
Changes from Baseline to each study visit in inflammatory lesion counts
Measured: Baseline through Week 12
Change in Non-inflammatory Lesions
Changes from Baseline to each study visit in non-inflammatory lesion counts
Measured: Baseline through Week 12
EGSS Results
Collection of EGSS results from Baseline visit through end of study Week 12
Measured: Baseline through Week 12
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Apr 2026
- Study start1 Apr 2026
- Primary completionDec 2027 (estimated)
- Study completionDec 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Acne VulgarisStudies of the same condition, open and under way.
- More trials run by Bausch Health Americas, Inc.The 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 4
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Bausch Health Americas, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- MedTrials Incorporated
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07524946
- Sponsor's protocol ID
- V01-126A-401
- Status last verified
- Jul 2026
- First submitted
- 5 Feb 2026
- Last updated
- 29 Jul 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 29 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A 12-Week, Phase 4, Open-Label Study To Assess Safety, Pharmacokinetics, and Treatment Effect of CABTREO (Clindamycin Phosphate 1.2%, Adapalene 0.15%, and Benzoyl Peroxide 3.1%) Topical Gel In Pediatric Participants Ages 9 to 11 Years, 11 Month With Acne Vulgaris
- ClinicalTrials.gov ID
- NCT07524946
- Acronym / sponsor ID
- V01-126A-401
- Conditions
- Acne Vulgaris
- Keywords
- Pediatric, Open-Label, Cabtreo, Acne Vulgaris, Topical
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Bausch Health Americas, Inc.Industry (pharma, biotech, devices)
- Collaborators
- MedTrials Incorporated
- Study start
- 1 Apr 2026 (actual)
- Primary completion
- Dec 2027 (estimated)
- Study completion
- Dec 2027 (estimated)
- First posted
- 13 Apr 2026 (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 study is to evaluate the safety, pharmacokinetics, and treatment effect for topically applied CABTREO lotion in pediatric participants ages 9 to 11 years, 11 months with Acne Vulgaris.
Detailed description
This is an open-label study designed to assess the safety, plasma PK, and treatment effect of topically applied CABTREO. This study includes both a main study and a PK sub-study. All participants will undergo a screening period of up to 5 weeks (up to 35 days) and a treatment period of up to 12 weeks (approximately 84 days). A subset of participants in the main study will be included in the PK sub-study. To be eligible for this study, participants must be between 9 years and 11 years, 11 months of age, inclusive, and have a clinical diagnosis of moderate to severe acne, defined as a score of 3 (moderate) or 4 (severe) on the Evaluator's Global Severity Score (EGSS). Participants must also have at least 30 facial acne inflammatory lesions, at least 35 facial acne noninflammatory lesions, and no more than 2 facial nodules; participants should also have acne lesions on at least 1 region of the trunk (chest, back, and/or shoulder).
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| All enrolled participants will receive CABTREO in this open-label study. | Other | Drug: CABTREO is a fixed-combination product of clindamycin phosphate 1.2%/BPO 3.1%/adapalene 0.15%.CABTREO is a fixed-combination product of clindamycin phosphate 1.2%/BPO 3.1%/adapalene 0.15%. |
Who may qualify
- Ages
- 9 to 11 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (13 listed)
- Male or female participants, ≥ 9 years of age and ≤ 11 years, 11 months of age at baseline
- Participants must provide verbal and signed, written informed consent; participants less than the age of consent must sign an assent for the study and a parent/legal guardian must sign the informed consent
- Participants must have a score of 3 (moderate) or 4 (severe) on the EGSS assessment at baseline
- Participants must have a facial acne inflammatory lesion (papules, pustules, and nodules) count ≥ 30 at baseline
- Participants must have a facial acne noninflammatory lesion (open and closed comedones) count ≥ 35 at baseline
Key exclusion criteria (32 listed)
- Use of an investigational drug or device within 30 days of enrollment or participation in a research study concurrent with this study
- Any dermatological conditions on the face that could interfere with clinical evaluations such as acne conglobata, acne fulminans, secondary acne, perioral dermatitis, clinically significant rosacea, gram-negative folliculitis, dermatitis, and/or eczema
- Any underlying disease(s) or other dermatological condition of the face that requires the use of interfering topical or systemic therapy, or makes evaluations and lesion counts inconclusive
- Participants with > 2 facial nodules at baseline
- Evidence or history of cosmetic-related acne
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 |
|---|---|---|
| CABTREO is a fixed-combination product of clindamycin phosphate 1.2%/BPO 3.1%/adapalene 0.15%.Also: IDP-126The study drug will be applied topically to the treatment areas at home, each the morning, for a period of 12 weeks, with the exception of study visit days (baseline [Day 1], and Days 14, 15 [PK substudy only], 28, 29 [PK substudy only], 56, and 84) where study drug will be applied by the participants after the study visit is completed at the study center. The study drug will be applied as a thin coating that is gently rubbed into the skin. | Drug | All enrolled participants will receive CABTREO in this open-label study. |
Primary outcome
Incidence of Treatment-Emergent Adverse Events
Time frame: All AEs will be followed from onset of the adverse event through the end of Study Week 12 visit
Starting after signing the informed consent/assent document, and continuing through the end of the study, participants will be assessed for the occurrence of new AEs and changes in ongoing AEs. The descriptions of all AEs will include the dates of onset and resolution (if resolved), maximum severity, seriousness, action taken regarding the study drug, corrective treatment, outcome, and the investigator's assessment of causality. Worsening of disease will not be considered an AE unless it results in discontinuation of the participant from the study or requires medical intervention prohibited by the protocol. All AEs will be followed to resolution or until stable, as determined by the investigator.
Change in Inflammatory Lesions
Time frame: Baseline through Week 12
Changes from Baseline to each study visit in inflammatory lesion counts
Change in Non-inflammatory Lesions
Time frame: Baseline through Week 12
Changes from Baseline to each study visit in non-inflammatory lesion counts
EGSS Results
Time frame: Baseline through Week 12
Collection of EGSS results from Baseline visit through end of study Week 12
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Jul 2026.
- Individual participant dataSharing planned: Undecided
Related trials for Acne Vulgaris
Not yet recruitingPhase 3
Evaluation of the Efficacy and Safety of Fractional CO₂ Laser With and Without Intradermal Botulinum Toxin A in the Treatment of Inflammatory Facial Acne Vulgaris.
Acne, Acne Papulopustulosa
RecruitingPhase 4
Safety, Tolerability, and Clinical Effectiveness of Adapalene/Clindamycin Phosphate Gel (Klenzit®-C) in Vietnamese Patients With Mild to Moderate Acne Vulgaris
Acne
RecruitingPhase 3
Phase 3 Study of Denifanstat in Participants With Moderate to Severe Acne (AURORA)
Acne Vulgaris
RecruitingPhase 4
Comparing Nadifloxacin Plus Tretinoin Versus Clindamycin Plus Tretinoin Creams for Mild-to-Moderate Acne
Acne Vulgaris
Active, not recruiting
Clinical Study to Evaluate the Safety and Efficacy of Candela Technology
Hair Reduction, Tattoo Removal
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.
15 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing CABTREO is a fixed-combination product of clindamycin phosphate 1.2%/BPO 3.1%/adapalene 0.15%. in people with Acne Vulgaris, run by Bausch Health Americas, Inc. at 15 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 13 inclusion and 32 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: looking for participants now, as of the sponsor's last update on 29 Jul 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 15 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.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Emily N Hughes, MACPR (731-415-3174, Emily.Hughes@BauschHealth.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Incidence of Treatment-Emergent Adverse Events (time frame: All AEs will be followed from onset of the adverse event through the end of Study Week 12 visit). 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?
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 29 Jul 2026.