Adult Skin Healthy SignsNCT03264677
An 8-week Full Face HUT Clinical Trial for HydroBoost (2.0/3.0)
A study testing Group 1, Group 2 and Group 3 in people with Adult Skin Healthy Signs, run by Johnson & Johnson Pte Ltd at 1 site in China.
Trial summary
To investigate the product regiments' performance on moisturization related skin healthy signs (skin moisturization, barrier function, elasticity, translucency, roughness and skin conditions) through instrumental evaluation, clinical grading and self-assessment before, during and after 8 weeks' home usage under city… Read more about this study
- Who is it for?
- Ages 18 to 40 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Adult Skin Healthy Signs
- What is being tested?
- Group 1, Group 2 and Group 3
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 122 participants
- Where
- 1 siteChina
- Study dates
- 18 May 2017to 25 Jul 2017
- 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 18 to 40 years
- Women only
- Healthy volunteers accepted
- Adult
Who may be able to join
- Chinese Females aged 18 - 40 years old in good physical and mental condition;
- Self-perceived dry facial skin without lesions. Corneometer score ≤35 arbitrary units on both sides of cheek areas;
- Having daily routine skin exposure (out-door activities) to city environmental challenge and having concern on its impact to healthy skin signs (e.g. Smoothness, Firmness, Translucency, Trouble (pimple, acne) free, Plumpness, etc.);
- Willing to stay in Shanghai City during the whole study period without travel plan;
- Having mild to moderate pre-aging sign, e.g. fine line, roughness when skin is dry. Having skin dullness concern on the face;
- Non-regular body moisturizer user. Expose the upper-chest site during study;
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- Willing to comply with the study instruction (see Appendix IX);
- Agree to use only water to wash face and upper chest, avoid using any cosmetic products (include but not limited to: wash/ soap/ moisturizer/ toner/ sparge/ sunscreen/ oil/ (water) mask/ scrub/ makeup/ fragrance/ light treatment/ massage, etc.) in the evening before each visit day. No washing on face and upper chest and no product application at home in the morning of the visit day. Subjects will wash the test areas when arrive the test site according to the site instruction;
- After enrollment, there will be a 3-day wash-in period, during which subjects agree to use water only to wash the face and upper chest twice per day in the morning and evening. Avoid using any cosmetic products as listed in above item 8 in both test areas;
- Then an 8-week home use period will follow, during which subjects agree to use the assigned product regimens (facial cleanser and facial cream) on face twice per day in the morning and evening. Use water only to wash the upper chest twice per day in the morning and evening. Avoid using any cosmetic products as listed in above item 8 in both test areas;
- After the 8-week home use of the assigned product regimens, subjects will stop using the products for 3 days (Regression period). Subjects agree to use water only to wash the face and upper chest twice per day in the morning and evening during the period. Avoid using any cosmetic products as listed in above item 8 in both test areas;
- Generally in good health based on medical history reported by the subject;
- Female subjects must meet one of the following criteria:
- Is not of child-bearing potential or is in a monogamous relationship with a partner who is not of child-bearing potential, meaning the subject and/or partner:
- Is post-menopausal (amenorrhea for at least 1 year),
- Had a surgical sterilization (e.g., vasectomy that has been confirmed effective by sperm count check, tubal occlusion, hysterectomy, bilateral oophorectomy or salpingectomy)
- Must agree to practice a medically acceptable form of birth control during the study and for 30 days after study completion. Female subjects must have used such birth control for at least 3 months prior to study start. Medically acceptable forms of birth control that may be used by the subject and/or partner include:
- Established use of hormonal methods of contraception (oral, injected, implanted, hormone patch or vaginal ring).
- Barrier methods of contraception: condom or occlusive cap (diaphragm or cervical/vault caps),
- Intrauterine device or intrauterine system,
- Abstinence from intercourse that could cause pregnancy. Periodic abstinence (e.g., calendar, ovulation, symptothermal, post-ovulation methods) and withdrawal are not acceptable methods of contraception.
- Is not a ward of the court or deprived from liberty by a judiciary or administrative decision;
- Able to read, write, speak and understand Chinese language or able to speak and understand Chinese language and accompanied by an impartial witness who can read, write, speak and understand Chinese language;
- Individual that has signed the Consent for Photograph Release (7-8 subjects/group) and ICD including portable tracker using and reporting as instruction;
Who cannot join
- Participated in any cosmetic clinical test involving facial and/or body product application within 3 months before enrollment.
- Has known allergies or adverse reactions to common topical skincare products;
- Presents with a skin condition that may influence the outcome of the study (e.g., psoriasis, eczema, melanomas), primary/secondary lesions on test sites (e.g. erythema, scars, ulcers, vesicles);
- Has a self-reported uncontrolled metabolic condition or disease, such as diabetes, hypertension, hyper/hypothyroidism, hypercholesterolemia, asthma, epilepsy, etc. Individuals with a controlled health condition may also be excluded from the study at the discretion of the PI, if medically qualified, or the designated study physician;
- Is taking medication for a chronic condition (e.g., insulin, antihistamines, steroidal and non-steroidal anti-inflammatory drugs, antibiotics, etc.) or is taking any other medication that could influence the study results and/or affect the individual's safety, within 30 days before inclusion or during the study;
- Is taking immunosuppressive drugs within 3 months before inclusion and during the study;
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- Has a history of or concurrent health condition/situation which, in the opinion of the PI, if medically qualified, or the designated study physician, may put the individual at significant risk, confound the study results, or interfere significantly with the individual's participation in the study;
- Is simultaneously participating in any other type of clinical study;
- Is an employee/contractor or immediate family member of the PI, Study Site staff or Sponsor.
Trial locations and contacts
1 site in 1 country.
China1 site
Shanghai Skin Disease Hospital
Shanghai, Shanghai Municipality, 200443
About this study
Official title: An 8-week Full Face HUT Design, Single Center, Double Blinded, Controlled and Randomized Study to Evaluate Different Product Regimens' Performance on Protecting Skin With Resilience Under Tracked City Environmental Aggressors
- To investigate the product regiments' performance on moisturization related skin healthy signs (skin moisturization, barrier function, elasticity, translucency, roughness and skin conditions) through instrumental evaluation, clinical grading and self-assessment before, during and after 8 weeks' home usage under city environmental aggressors (Sun, change of temperature and humidity, wind and air pollution) among 3 product regimens and Non-treatment control;
- To explore the linkage among products efficacy, ambient aggressors, and life habits;
- To investigate product regimens' tolerance and safety via Home Use Test;
- To collect skin microflora/microbiome samples for potential research on skin microbiome distribution change as impacted by product application and/or environmental aggressors change (data will be analyzed and reported separately).
Read the detailed description
This is a single center, double blinded, controlled and randomized 8-week home use clinical trial.
Subjects will be randomly and evenly divided into 3 groups (40subjects/group) with different facial care regimens during the 8-week home use study.
Group 1: NTG Hydro Boost Gelee Milk Cleanser + NTG Hydro Boost Kiwi Water Gel Group 2: NTG Hydro Boost Gelee Milk Cleanser + NTG Hydro Boost Water Gel Group 3: NTG Hydro Boost Gelee Milk Cleanser + NTG Hydro Boost Extra Dry Emulsion There will be a 3-day wash-in period after subject's enrollment. During the period, no product will be allowed to be applied on the face and upper chest but only water washes twice per day in the morning and evening for 3 days before baseline (BL) measurement.
After baseline (BL) measurement, the product regimens will be applied on face at site under site instruction according to the randomization. Measurements will be taken at 2-4 hours and 8 hours after product regimens' application. Upper chest area will be measured as no treatment control.
A set of product regimen includes a facial cleanser and a facial cream will be distributed to each subject according to grouping and applied on the face at home for 8 weeks. Both cleanser and cream products will be applied twice a day in the morning and evening on the whole face. For the upper chest area, use water wash only twice per day in the morning and evening, no any other product is allowed.
The usage of assigned product regimens will be discontinued after 8-week home use, no any other product is allowed but only water wash twice per day in the morning and evening on both face and upper chest for 3 days (regression period).
Subjects will not be allowed to use sunscreen, makeup and any other cosmetic products on face and upper chest during the study period.
Subjects will visit the site at Screening (-3D), Baseline (BL), 1-week (1W), 4-week (4W), 8-week (8W) and 8-week+3-days (+3D) for measurements.
- Conditions
- Adult Skin Healthy Signs
- Being tested
- Group 1, Group 2, Group 3
- Keywords
- 8-week HUT, Hydro Boost, Skin healthy signs, Environmental aggressors, Cosmetic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Group 1Combination product
Also called HB Cleanser+Kiwi Water Gel
NTG Hydro Boost Gelee Milk Cleanser + NTG Hydro Boost Kiwi Water Gel
Group 2Combination product
Also called HB Cleanser+HB Water Gel
NTG Hydro Boost Gelee Milk Cleanser + NTG Hydro Boost Water Gel
Group 3Combination product
Also called HB Cleanser+HB ED Emulsion
NTG Hydro Boost Gelee Milk Cleanser + NTG Hydro Boost Extra Dry Emulsion
| Study group | Role | What they receive |
|---|---|---|
| Group 1 | Experimental | NTG Hydro Boost Gelee Milk Cleanser + NTG Hydro Boost Kiwi Water Gel Receives: Combination Product: Group 1 |
| Group 2 | Experimental | NTG Hydro Boost Gelee Milk Cleanser + NTG Hydro Boost Water Gel Receives: Combination Product: Group 2 |
| Group 3 | Experimental | NTG Hydro Boost Gelee Milk Cleanser + NTG Hydro Boost Extra Dry Emulsion Receives: Combination Product: Group 3 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Skin surface moisture content
Skin surface moisture content is measured by skin capacitance measurement.
Measured: 9 weeks
Secondary outcomes (22)
Quality of Life
In this study, an evaluation tool will be used to measure and quantify skin dryness related Quality of Life (QoL) attributes, to get an understanding of the improvement (related to moisturization benefits) after treatment of skin care regimens
Measured: 9 weeks
Subject Self-assessment
Subject self-assessment Questionnaire (QN) on product performance
Measured: 9 weeks
Temperature
Individual temperature measured by portable environmental tracker
Measured: 9 weeks
Humidity
Individual humidity measured by portable environmental tracker
Measured: 9 weeks
PM 2.5
Individual PM 2.5 measured by portable environmental tracker
Measured: 9 weeks
Skin microbiome
To collect skin microflora/microbiome samples for potential research on skin microbiome distribution change as impacted by product application and/or environmental aggressors change.
Measured: 9 weeks
Life habits
Subject's life pattern captured by diary.
Measured: 9 weeks
Skin barrier function
TEWL
Measured: 9 weeks
Skin elasticity
The mechanical property of the epidermis is measured by a non-invasive, in vivo suction skin elasticity meter.
Measured: 9 weeks
Skin roughness
Skin roughness measurement via skin surface imaging
Measured: 9 weeks
Skin translucency
Many common materials transmit and scatter light but are neither transparent or opaque. Such materials are described as translucent and the degree of translucency depends on the absorption and scattering coefficients of the material. In this study, the degree of skin translucency is quantified by the rate of lateral scatter of light and the total amount of backscattered light, which captured by a non-invasive Translucency Meter probe.
Measured: 9 weeks
Skin deep layer moisture content
Skin deep layer moisture content by measuring skin dielectric constant.
Measured: 9 weeks
Skin firmness
Dermatologist grading of skin firmness
Measured: 9 weeks
Skin elasticity
Dermatologist grading of skin elasticity
Measured: 9 weeks
Skin radiance
Dermatologist grading of skin radiance
Measured: 9 weeks
Skin smoothness
Dermatologist grading of skin smoothness
Measured: 9 weeks
Skin fine lines
Dermatologist grading of skin fine lines
Measured: 9 weeks
Skin softness
Dermatologist grading of skin softness
Measured: 9 weeks
Skin hydration
Dermatologist grading of skin hydration
Measured: 9 weeks
Skin translucency
Dermatologist grading of skin translucency
Measured: 9 weeks
Pimple
Dermatologist grading of pimple
Measured: 9 weeks
Clogged pores
Dermatologist grading of clogged Pores
Measured: 9 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Aug 2017
- Study start18 May 2017
- Primary completion25 Jul 2017
- Study completion25 Jul 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Adult Skin Healthy 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 N/A
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Subjects will be randomly and evenly divided into 3 groups (approx. 40 subjects per group) with different facial care regimens during the 8-week home use study. Group 1: NTG Hydro Boost Gelee Milk Cleanser + NTG Hydro Boost Kiwi Water Gel Group 2: NTG Hydro Boost Gelee Milk Cleanser + NTG Hydro Boost Water Gel Group 3: NTG Hydro Boost Gelee Milk Cleanser + NTG Hydro Boost Extra Dry Emulsion
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 122 participants (actual)
Sponsor and investigators
- Lead sponsor
- Johnson & Johnson Pte Ltd
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Shanghai Skin Disease Hospital, Shanghai China-Norm Management Consulting co.,LTD
- Responsible party
- Sponsor
- Investigators
- Chao Yuan, Principal investigator, Shanghai Skin Disease Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03264677
- Sponsor's protocol ID
- CO-170223145432-SACT
- Status last verified
- Apr 2018
- First submitted
- 24 Jul 2017
- Last updated
- 11 Apr 2018
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 11 Apr 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An 8-week Full Face HUT Design, Single Center, Double Blinded, Controlled and Randomized Study to Evaluate Different Product Regimens' Performance on Protecting Skin With Resilience Under Tracked City Environmental Aggressors
- ClinicalTrials.gov ID
- NCT03264677
- Acronym / sponsor ID
- CO-170223145432-SACT
- Conditions
- Adult Skin Healthy Signs
- Keywords
- 8-week HUT, Hydro Boost, Skin healthy signs, Environmental aggressors, Cosmetic
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 122 participants (actual)
- Lead sponsor
- Johnson & Johnson Pte LtdIndustry (pharma, biotech, devices)
- Collaborators
- Shanghai Skin Disease Hospital, Shanghai China-Norm Management Consulting co.,LTD
- Study start
- 18 May 2017 (actual)
- Primary completion
- 25 Jul 2017 (actual)
- Study completion
- 25 Jul 2017 (actual)
- First posted
- 29 Aug 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
- To investigate the product regiments' performance on moisturization related skin healthy signs (skin moisturization, barrier function, elasticity, translucency, roughness and skin conditions) through instrumental evaluation, clinical grading and self-assessment before, during and after 8 weeks' home usage under city environmental aggressors (Sun, change of temperature and humidity, wind and air pollution) among 3 product regimens and Non-treatment control;
- To explore the linkage among products efficacy, ambient aggressors, and life habits;
- To investigate product regimens' tolerance and safety via Home Use Test;
- To collect skin microflora/microbiome samples for potential research on skin microbiome distribution change as impacted by product application and/or environmental aggressors change (data will be analyzed and reported separately).
Detailed description
This is a single center, double blinded, controlled and randomized 8-week home use clinical trial.
Subjects will be randomly and evenly divided into 3 groups (40subjects/group) with different facial care regimens during the 8-week home use study.
Group 1: NTG Hydro Boost Gelee Milk Cleanser + NTG Hydro Boost Kiwi Water Gel Group 2: NTG Hydro Boost Gelee Milk Cleanser + NTG Hydro Boost Water Gel Group 3: NTG Hydro Boost Gelee Milk Cleanser + NTG Hydro Boost Extra Dry Emulsion There will be a 3-day wash-in period after subject's enrollment. During the period, no product will be allowed to be applied on the face and upper chest but only water washes twice per day in the morning and evening for 3 days before baseline (BL) measurement.
After baseline (BL) measurement, the product regimens will be applied on face at site under site instruction according to the randomization. Measurements will be taken at 2-4 hours and 8 hours after product regimens' application. Upper chest area will be measured as no treatment control.
A set of product regimen includes a facial cleanser and a facial cream will be distributed to each subject according to grouping and applied on the face at home for 8 weeks. Both cleanser and cream products will be applied twice a day in the morning and evening on the whole face. For the upper chest area, use water wash only twice per day in the morning and evening, no any other product is allowed.
The usage of assigned product regimens will be discontinued after 8-week home use, no any other product is allowed but only water wash twice per day in the morning and evening on both face and upper chest for 3 days (regression period).
Subjects will not be allowed to use sunscreen, makeup and any other cosmetic products on face and upper chest during the study period.
Subjects will visit the site at Screening (-3D), Baseline (BL), 1-week (1W), 4-week (4W), 8-week (8W) and 8-week+3-days (+3D) for measurements.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 3
- Model description
- Subjects will be randomly and evenly divided into 3 groups (approx. 40 subjects per group) with different facial care regimens during the 8-week home use study. Group 1: NTG Hydro Boost Gelee Milk Cleanser + NTG Hydro Boost Kiwi Water Gel Group 2: NTG Hydro Boost Gelee Milk Cleanser + NTG Hydro Boost Water Gel Group 3: NTG Hydro Boost Gelee Milk Cleanser + NTG Hydro Boost Extra Dry Emulsion
| Arm | Type | Receives |
|---|---|---|
| Group 1 | Experimental | Combination Product: Group 1NTG Hydro Boost Gelee Milk Cleanser + NTG Hydro Boost Kiwi Water Gel |
| Group 2 | Experimental | Combination Product: Group 2NTG Hydro Boost Gelee Milk Cleanser + NTG Hydro Boost Water Gel |
| Group 3 | Experimental | Combination Product: Group 3NTG Hydro Boost Gelee Milk Cleanser + NTG Hydro Boost Extra Dry Emulsion |
Who may qualify
- Ages
- 18 to 40 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (24 listed)
- Chinese Females aged 18 - 40 years old in good physical and mental condition;
- Self-perceived dry facial skin without lesions. Corneometer score ≤35 arbitrary units on both sides of cheek areas;
- Having daily routine skin exposure (out-door activities) to city environmental challenge and having concern on its impact to healthy skin signs (e.g. Smoothness, Firmness, Translucency, Trouble (pimple, acne) free, Plumpness, etc.);
- Willing to stay in Shanghai City during the whole study period without travel plan;
- Having mild to moderate pre-aging sign, e.g. fine line, roughness when skin is dry. Having skin dullness concern on the face;
Key exclusion criteria (9 listed)
- Participated in any cosmetic clinical test involving facial and/or body product application within 3 months before enrollment.
- Has known allergies or adverse reactions to common topical skincare products;
- Presents with a skin condition that may influence the outcome of the study (e.g., psoriasis, eczema, melanomas), primary/secondary lesions on test sites (e.g. erythema, scars, ulcers, vesicles);
- Has a self-reported uncontrolled metabolic condition or disease, such as diabetes, hypertension, hyper/hypothyroidism, hypercholesterolemia, asthma, epilepsy, etc. Individuals with a controlled health condition may also be excluded from the study at the discretion of the PI, if medically qualified, or the designated study physician;
- Is taking medication for a chronic condition (e.g., insulin, antihistamines, steroidal and non-steroidal anti-inflammatory drugs, antibiotics, etc.) or is taking any other medication that could influence the study results and/or affect the individual's safety, within 30 days before inclusion or during the study;
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 |
|---|---|---|
| Group 1Also: HB Cleanser+Kiwi Water GelNTG Hydro Boost Gelee Milk Cleanser + NTG Hydro Boost Kiwi Water Gel | Combination product | Group 1 |
| Group 2Also: HB Cleanser+HB Water GelNTG Hydro Boost Gelee Milk Cleanser + NTG Hydro Boost Water Gel | Combination product | Group 2 |
| Group 3Also: HB Cleanser+HB ED EmulsionNTG Hydro Boost Gelee Milk Cleanser + NTG Hydro Boost Extra Dry Emulsion | Combination product | Group 3 |
Primary outcome
Skin surface moisture content
Time frame: 9 weeks
Skin surface moisture content is measured by skin capacitance measurement.
22 secondary outcomes
Quality of Life
Time frame: 9 weeks
Subject Self-assessment
Time frame: 9 weeks
Temperature
Time frame: 9 weeks
Humidity
Time frame: 9 weeks
PM 2.5
Time frame: 9 weeks
Skin microbiome
Time frame: 9 weeks
Life habits
Time frame: 9 weeks
Skin barrier function
Time frame: 9 weeks
Skin elasticity
Time frame: 9 weeks
Skin roughness
Time frame: 9 weeks
Skin translucency
Time frame: 9 weeks
Skin deep layer moisture content
Time frame: 9 weeks
Skin firmness
Time frame: 9 weeks
Skin elasticity
Time frame: 9 weeks
Skin radiance
Time frame: 9 weeks
Skin smoothness
Time frame: 9 weeks
Skin fine lines
Time frame: 9 weeks
Skin softness
Time frame: 9 weeks
Skin hydration
Time frame: 9 weeks
Skin translucency
Time frame: 9 weeks
Pimple
Time frame: 9 weeks
Clogged pores
Time frame: 9 weeks
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 11 Apr 2018.
- Related InfoLink provided by the sponsor.
- 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.
Chao Yuan principal investigator
Shanghai Skin Disease Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Group 1, Group 2 and Group 3 in people with Adult Skin Healthy Signs, run by Johnson & Johnson Pte Ltd at 1 site in China.
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 24 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 11 Apr 2018. 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 China. 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?
Skin surface moisture content (time frame: 9 weeks). 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 11 Apr 2018.