Improve Photoaging SignsPhase 2/3NCT06603857
Skin Care Regimen for Improving Photoaging Signs on the Face
A Phase 2/3 study testing CE Ferulic and 1927nm (Clear and Brilliant Perméa®) in people with Improve Photoaging Signs, run by Goldman, Butterwick, Fitzpatrick and Groff at 1 site in United States.
Trial summary
Compare the effectiveness of laser treatment using CE Ferulic versus vehicle pre/post laser. Read more about this study
- Who is it for?
- Ages 30 to 70 years
- Conditions the study is for
- Improve Photoaging Signs
- What is being tested?
- CE Ferulic and 1927nm (Clear and Brilliant Perméa®)
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 40 participants
- Where
- 1 siteUnited States
- Study dates
- 27 Sep 2024to 28 Feb 2025
- Phase
- Phase 2/3
- 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 30 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Adult males and females aged 30-70 years (Fitzpatrick I-IV 30-65 years, Fitzpatrick V-VI 30-70 years)
- Fitzpatrick skin types I-VI
- Subjects in good general health based on investigator's judgment and medical history
- Must be willing to give and sign an informed consent form and photographic release form
- Must be willing to have examinations of face and digital photographs performed of the face
- Physician evaluator classifying the subject as mild to moderate (Score 3-6) on the modified Griffiths 10-Point Scale for the face.
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- The subject must be planning to undergo fractional non-ablative laser resurfacing to the face and bilateral postauricular area and be willing to comply with study protocol and complete the entire course of the study.
- Subjects using any treatment skincare products (per investigator discretion) must discontinue use of these products four weeks before the start of participating in this clinical study and for the duration of the study.
- Male subjects with facial hair must be willing to shave prior to every visit.
- Must be willing to maintain usual sun exposure
- Subject agrees to avoid tanning or use of sunless tanner during the entire course of the study
- Negative urine pregnancy test result at the time of study entry (if applicable)
- For female subjects of childbearing potential, must be willing to use an acceptable form of birth control during the entire course of the study. All systemic birth control measures must be in consistent use for at least 30 days prior to study enrollment.
- A female is considered of childbearing potential unless she is postmenopausal, without a uterus and/or both ovaries, or has had a bilateral tubal ligation.
- Acceptable methods of birth control are: oral contraceptives, contraceptive patches/rings/implants, Implanon®, Depo-Provera®, double-barrier methods (e.g., condoms and spermicide), abstinence, and/or vasectomy of partner with a documented second acceptable method of birth control, should the subject become sexually active.
- Must be willing to comply with study treatments and complete the entire course of the study
Who cannot join
- Energy-based device (i.e., radiofrequency device treatments, microfocused ultrasound device or other ultrasound-based device treatments, laser and light-based device treatments, microneedling) treatment in the treatment area in the last 6 months
- Chemical peel or microdermabrasion of the face within 60 days prior to enrollment in the study
- Dermal fillers, biostimulators, or neurotoxins treatments of the face during the 6-month period before the study period or planning to undergo during the study period
- Surgery (i.e., face lift, eyebrow lift, neck lift or lower rhytidectomy, liposuction to the neck and/or submentum, etc.) during the 12-month period before study treatment
- Any investigational treatment for improvement of skin quality and/or photodamage of facial skin during the 6-month period before the study treatment
- Use of topical steroids, tretinoin, adapalene, tazarotene, hydroquinone, imiquimod, 5-fluorouracil, ingenol mebutate, concentrated hydrogen peroxide, diclofenac, or photodynamic therapy (PDT) to the face within the previous 4 weeks
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- Subjects must not currently be taking isotretinoin (Accutane).
- Creams/cosmeceuticals and/or home therapies to prevent or treat photodamage, uneven skin pigmentation, excessive erythema (redness), fine lines/wrinkles, skin laxity and/or pore size during the 4-week period before study treatment
- Subjects with scarring in the treatment areas
- Subjects with tattoos in the treatment areas
- Subjects with a significant history or current evidence of a medical, psychological, or other disorder that, in the investigator's opinion, would preclude enrollment into the study
- Subjects with a history of or presence of any skin condition/disease (including but not limited to any visible rash, atopic dermatitis, psoriasis, actinic keratoses, keratinocyte carcinoma, melanoma, etc.) in the treatment area that might interfere with the diagnosis or evaluation of study parameters
- Skin with open wounds, excessively sensitive skin, neurotic excoriations, dermatitis or inflammatory rosacea in the treatment area
- History of keloid or hypertrophic scarring
- Subjects with an active bacterial, viral, or fungal infection of the treatment areas or systemic infection
- Subjects who spray tanned or used sunless tanners in the treatment areas four (4) weeks prior to study treatment
- History of lidocaine and/or tetracaine sensitivity deemed by the investigator to preclude the subject from enrolling into the study
- Individuals with known allergies or sensitivities to any of the ingredients of any topical or injectable products being used in this study
- Subjects must not have a compromised ability for wound healing, such as:
- malnutrition, steroid use, history of collagen vascular disease (e.g., lupus, scleroderma), atopic dermatitis, or immunologic abnormalities such as vitiligo.
- Subjects planning any cosmetic procedure to the treatment areas during the study period, other than the treatment that will be performed by the investigator
- Presence of incompletely healed wound(s) in the treatment area
- Subjects who are on an immunosuppressant or have an autoimmune condition
- Female subjects who are pregnant, planning a pregnancy, or breast feeding during the study
- Current participation or participation within 30 days prior to the start of this study in a drug or other investigational research study
Trial locations and contacts
1 site in 1 country.
United States1 site
West Dermatology Research Center
San Diego, California, 92121
About this study
Official title: A Prospective, Placebo-controlled, Double-blinded, Randomized Clinical Trial Evaluating the Efficacy and Tolerability of Pre and Post Care Skincare Regimen Paired With 1927nm Diode Fractional Laser for Photodamage on the Face
Compare the effectiveness of laser treatment using CE Ferulic versus vehicle pre/post laser.
Read the detailed description
Evaluate the efficacy and tolerability of a Skinceuticals CE Ferulic® when used once daily over the course of 14 weeks with 2-week pre-treatment period and 12-week treatment period in pairing with two pre-elected laser treatments with 1927nm non-ablative fractional diode laser treatment for improving skin photoaging signs on the face.
- Conditions
- Improve Photoaging Signs
- Being tested
- CE Ferulic, Sham Comparator, 1927nm (Clear and Brilliant Perméa®)
- Keywords
- wrinkles, aging, photodamage
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CE FerulicDrug
CE Ferulic serum regimen combined with laser treatment
Sham ComparatorDrug
Vehicle serum regimen combined with laser treatment
1927nm (Clear and Brilliant Perméa®)Device
non-ablative fractional diode laser
| Study group | Role | What they receive |
|---|---|---|
| Group A | Active comparator | Subjects who will receive two treatments with 1927nm (Clear and Brilliant Perméa®) non-ablative fractional diode laser for rejuvenation of photodamaged skin of the face in pairing with Skinceuticals CE Ferulic Receives: Drug: CE Ferulic; Device: 1927nm (Clear and Brilliant Perméa®) |
| Group B | Sham comparator | Subjects who will receive two treatments with 1927nm (Clear and Brilliant Perméa®) non-ablative fractional diode laser for rejuvenation of photodamaged skin of the face in pairing with vehicle serum Receives: Drug: Sham Comparator; Device: 1927nm (Clear and Brilliant Perméa®) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Global Fine Lines
Score 0 thru 9
Score 0= No fine lines present; skin looks completely smooth Score 9= Numerous, many fine lines densely packed together in the treatment area
Measured: Screening, Baseline, Day 28, Day 56, Day 84
Overall Hyperpigmentation/ Discoloration
Score 0 thru 9
Score 0= No hyperpigmentation Score 9= Significant hyperpigmentation, numerous spots, uneven skin tone
Measured: Screening, Baseline, Day 28, Day 56, Day 84
Skin Tone Evenness
Score 0 thru 9
Score 0= Very even tone Score 9= Uneven, discolored appearance (brown and/or red colors)
Measured: Screening, Baseline, Day 28, Day 56, Day 84
Skin Elasticity
Score 0 thru 9
Score 0= Skin feels toned, dense Score 9= Skin feels pliable, thin and non-resilient
Measured: Screening, Baseline, Day 28, Day 56, Day 84
Skin Firmness
Score 0 thru 9
Score 0= Firm, tight feeling skin Score 9= Loose, lax feeling skin
Measured: Screening, Baseline, Day 28, Day 56, Day 84
Skin Radiance/ Brightness
Score 0 thru 9
Score 0= Very radiant, luminous or glowing appearance Score 9= Very dull/ matte and/or sallow skin appearance
Measured: Screening, Baseline, Day 28, Day 56, Day 84
Skin Texture Smoothness
Score 0 thru 9
Score 0= Very smooth, even-looking skin texture, no roughness Score 9= Very rough, pronounced, extensive visible skin roughness
Measured: Screening, Baseline, Day 28, Day 56, Day 84
Global Wrinkles
Score 0 thru 9
Score 0= No wrinkles present, no visible deep, wide and long wrinkles, skin looks smooth Score 9= Numerous wrinkles, deep, wide and long, densely packed together in the treatment area
Measured: Screening, Baseline, Day 28, Day 56, Day 84
Secondary outcomes (6)
Tolerability Assessment
Stinging/Burning:
None No stinging/burning of the treatment area Mild Slight, but definite burning of the treatment area Moderate Definite stinging/burning of the treatment area Severe Marked stinging/burning of the treatment area
Itching:
None No itching of the treatment area Mild Slight, but definite itching of the treatment area Moderate Definite itching of the treatment area Severe Marked itching of the treatment area
Rash:
None No new rash over the treatment area Mild New rash covering some of the treatment area Moderate New rash covering much of the treatment area Severe New rash covering the entirety of the treatment area
Tightness:
None No tightness of the treatment area Mild Slight, but definite tightness of the treatment area Moderate Definite tightness of the treatment area Severe Marked tightness of the treatment area
Measured: Baseline, Day 28
Dermatology Quality of Life Index (Page 1)
- Over the last week, how itchy, sore, painful or stinging has your skin been: Very Much A lot A little Not at all
- Over the last week, how embarrassed or self-conscious have you been because of your skin: Very Much A lot A little Not at all
- Over the last week, how much has your skin interfered with you going shopping or looking after your home or garden: Very Much A lot A little Not at all
- Over the last week, how much has your skin influenced the clothes you wear: Very Much A lot A little Not at all
- Over the last week, how itchy, sore, painful or stinging has your skin been: Very Much A lot A little Not at all
- Over the last week, how much has your skin made it difficult for you to do any sport:
Very Much A lot A little Not at all
Measured: Screening, Baseline, Day 28, Day 56, Day 84
Dermatology Quality of Life Index (Page 2)
7.Over the last week, has your skin prevented you from working or studying: Yes or No 7a. If \"no\", over the last week how much has your skin been a problem at work or studying: Very Much A lot A little Not at all
8.Over the last week, how much has your skin created problems with your partner or any of your close friends or relatives: Very Much A lot A little Not at all
9.Over the last week, how much has your skin caused any sexual difficulties: Very Much A lot A little Not at all
10.Over the last week, how much of a problem has the treatment for your skin been, for example by making your home messy, or by taking up time: Very Much A lot A little Not at all
Measured: Screening, Baseline, Day 28, Day 56, Day 84
Subject Self-Assessment Questionnaire (Page 1)
- Skin feels more comfortable: Agree Strongly Agree Neither agree nor disagree Disagree Disagree Strongly
- Skin appears younger looking: Agree Strongly Agree Neither agree nor disagree Disagree Disagree Strongly
- Skin appears healthier: Agree Strongly Agree Neither agree nor disagree Disagree Disagree Strongly
- Skin looks renewed/ revitalized: Agree Strongly Agree Neither agree nor disagree Disagree Disagree Strongly
- Skin looks firmer: Agree Strongly Agree Neither agree nor disagree Disagree Disagree Strongly
- Skin feels elastic: Agree Strongly Agree Neither agree nor disagree Disagree Disagree Strongly
- Redness looks reduced:
Agree Strongly Agree Neither agree nor disagree Disagree Disagree Strongly
Measured: Screening, Baseline, Day 28, Day 56, Day 84
Subject Self-Assessment Questionnaire (Page 2)
- With the product I\'m more satisfied with the procedure results: Agree Strongly Agree Neither agree nor disagree Disagree Disagree Strongly
- The product reduced the downtime of the procedure or makes the downtime more acceptable: Agree Strongly Agree Neither agree nor disagree Disagree Disagree Strongly
- The product improves the outcome of the procedure: Agree Strongly Agree Neither agree nor disagree Disagree Disagree Strongly
- With this product, I would feel more confident to do another procedure: Agree Strongly Agree Neither agree nor disagree Disagree Disagree Strongly
- I would recommend this product post-procedure: Agree Strongly Agree Neither agree nor disagree Disagree Disagree Strongly
Measured: Screening, Baseline, Day 28, Day 56, Day 84
Subject Self-Assessment Questionnaire (Page 3)
- It\'s the best post-procedure care I\'ve ever used (if relevant) : Agree Strongly Agree Neither agree nor disagree Disagree Disagree Strongly
- It is something I would use after future laser treatments: Agree Strongly Agree Neither agree nor disagree Disagree Disagree Strongly
- The product has a pleasant texture: Agree Strongly Agree Neither agree nor disagree Disagree Disagree Strongly
- The product absorbs quickly in to the skin: Agree Strongly Agree Neither agree nor disagree Disagree Disagree Strongly
- It is a product I would recommend to others: Agree Strongly Agree Neither agree nor disagree Disagree Disagree Strongly
Measured: Screening, Baseline, Day 28, Day 56, Day 84
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Sep 2024
- Study start27 Sep 2024 (estimated)
- Primary completion31 Dec 2024 (estimated)
- Study completion28 Feb 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Improve Photoaging SignsStudies 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 2/3
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Prospective, placebo-controlled, double-blinded, randomized study
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Goldman, Butterwick, Fitzpatrick and Groff
- Sponsor type
- University, hospital or other
- Collaborators
- L'Oreal
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06603857
- Sponsor's protocol ID
- Skinceuticals CE Ferulic 2024
- Status last verified
- Sep 2024
- First submitted
- 12 Sep 2024
- Last updated
- 19 Sep 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
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 Prospective, Placebo-controlled, Double-blinded, Randomized Clinical Trial Evaluating the Efficacy and Tolerability of Pre and Post Care Skincare Regimen Paired With 1927nm Diode Fractional Laser for Photodamage on the Face
- ClinicalTrials.gov ID
- NCT06603857
- Acronym / sponsor ID
- Skinceuticals CE Ferulic 2024
- Conditions
- Improve Photoaging Signs
- Keywords
- wrinkles, aging, photodamage
- Phase
- Phase 2/3
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- Goldman, Butterwick, Fitzpatrick and GroffUniversity, hospital or other
- Collaborators
- L'Oreal
- Study start
- 27 Sep 2024 (estimated)
- Primary completion
- 31 Dec 2024 (estimated)
- Study completion
- 28 Feb 2025 (estimated)
- First posted
- 19 Sep 2024 (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.
Compare the effectiveness of laser treatment using CE Ferulic versus vehicle pre/post laser.
Detailed description
Evaluate the efficacy and tolerability of a Skinceuticals CE Ferulic® when used once daily over the course of 14 weeks with 2-week pre-treatment period and 12-week treatment period in pairing with two pre-elected laser treatments with 1927nm non-ablative fractional diode laser treatment for improving skin photoaging signs on the face.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
- Model description
- Prospective, placebo-controlled, double-blinded, randomized study
| Arm | Type | Receives |
|---|---|---|
| Group A | Active comparator | Drug: CE Ferulic, Device: 1927nm (Clear and Brilliant Perméa®)Subjects who will receive two treatments with 1927nm (Clear and Brilliant Perméa®) non-ablative fractional diode laser for rejuvenation of photodamaged skin of the face in pairing with Skinceuticals CE Ferulic |
| Group B | Sham comparator | Drug: Sham Comparator, Device: 1927nm (Clear and Brilliant Perméa®)Subjects who will receive two treatments with 1927nm (Clear and Brilliant Perméa®) non-ablative fractional diode laser for rejuvenation of photodamaged skin of the face in pairing with vehicle serum |
Who may qualify
- Ages
- 30 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (16 listed)
- Adult males and females aged 30-70 years (Fitzpatrick I-IV 30-65 years, Fitzpatrick V-VI 30-70 years)
- Fitzpatrick skin types I-VI
- Subjects in good general health based on investigator's judgment and medical history
- Must be willing to give and sign an informed consent form and photographic release form
- Must be willing to have examinations of face and digital photographs performed of the face
Key exclusion criteria (25 listed)
- Energy-based device (i.e., radiofrequency device treatments, microfocused ultrasound device or other ultrasound-based device treatments, laser and light-based device treatments, microneedling) treatment in the treatment area in the last 6 months
- Chemical peel or microdermabrasion of the face within 60 days prior to enrollment in the study
- Dermal fillers, biostimulators, or neurotoxins treatments of the face during the 6-month period before the study period or planning to undergo during the study period
- Surgery (i.e., face lift, eyebrow lift, neck lift or lower rhytidectomy, liposuction to the neck and/or submentum, etc.) during the 12-month period before study treatment
- Any investigational treatment for improvement of skin quality and/or photodamage of facial skin during the 6-month period before the study treatment
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 |
|---|---|---|
| CE FerulicCE Ferulic serum regimen combined with laser treatment | Drug | Group A |
| Sham ComparatorVehicle serum regimen combined with laser treatment | Drug | Group B |
| 1927nm (Clear and Brilliant Perméa®)non-ablative fractional diode laser | Device | Group A, Group B |
Primary outcome
Global Fine Lines
Time frame: Screening, Baseline, Day 28, Day 56, Day 84
Score 0 thru 9 Score 0= No fine lines present; skin looks completely smooth Score 9= Numerous, many fine lines densely packed together in the treatment area
Overall Hyperpigmentation/ Discoloration
Time frame: Screening, Baseline, Day 28, Day 56, Day 84
Score 0 thru 9 Score 0= No hyperpigmentation Score 9= Significant hyperpigmentation, numerous spots, uneven skin tone
Skin Tone Evenness
Time frame: Screening, Baseline, Day 28, Day 56, Day 84
Score 0 thru 9 Score 0= Very even tone Score 9= Uneven, discolored appearance (brown and/or red colors)
Skin Elasticity
Time frame: Screening, Baseline, Day 28, Day 56, Day 84
Score 0 thru 9 Score 0= Skin feels toned, dense Score 9= Skin feels pliable, thin and non-resilient
Skin Firmness
Time frame: Screening, Baseline, Day 28, Day 56, Day 84
Score 0 thru 9 Score 0= Firm, tight feeling skin Score 9= Loose, lax feeling skin
Skin Radiance/ Brightness
Time frame: Screening, Baseline, Day 28, Day 56, Day 84
Score 0 thru 9 Score 0= Very radiant, luminous or glowing appearance Score 9= Very dull/ matte and/or sallow skin appearance
Skin Texture Smoothness
Time frame: Screening, Baseline, Day 28, Day 56, Day 84
Score 0 thru 9 Score 0= Very smooth, even-looking skin texture, no roughness Score 9= Very rough, pronounced, extensive visible skin roughness
Global Wrinkles
Time frame: Screening, Baseline, Day 28, Day 56, Day 84
Score 0 thru 9 Score 0= No wrinkles present, no visible deep, wide and long wrinkles, skin looks smooth Score 9= Numerous wrinkles, deep, wide and long, densely packed together in the treatment area
6 secondary outcomes
Tolerability Assessment
Time frame: Baseline, Day 28
Dermatology Quality of Life Index (Page 1)
Time frame: Screening, Baseline, Day 28, Day 56, Day 84
Dermatology Quality of Life Index (Page 2)
Time frame: Screening, Baseline, Day 28, Day 56, Day 84
Subject Self-Assessment Questionnaire (Page 1)
Time frame: Screening, Baseline, Day 28, Day 56, Day 84
Subject Self-Assessment Questionnaire (Page 2)
Time frame: Screening, Baseline, Day 28, Day 56, Day 84
Subject Self-Assessment Questionnaire (Page 3)
Time frame: Screening, Baseline, Day 28, Day 56, Day 84
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Sep 2024.
- Individual participant dataSharing planned: No
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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2/3 study testing CE Ferulic and 1927nm (Clear and Brilliant Perméa®) in people with Improve Photoaging Signs, run by Goldman, Butterwick, Fitzpatrick and Groff 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 16 inclusion and 25 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 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 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. 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 combined phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
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?
Contact West Dermatology Research Center (858-657-1004, research@clderm.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Global Fine Lines (time frame: Screening, Baseline, Day 28, Day 56, Day 84). The study lists 8 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 19 Sep 2024.