Self EsteemNCT05945472
Beauty as a State of Wellness Beauty as a State of Wellbeing in Women 40 to 64 Years of Age
A study testing Positive reinforcement method and Standard method in people with Self Esteem and Psychological Well-being, run by Instituto de Investigación Sanitaria Aragón at 1 site in Spain.
Trial summary
The sociocultural pressure towards women's body image is one of the problems that today afflicts much of the female population. It is a reality that society exerts a strong pressure on body image, particularly on women. Read more about this study
- Who is it for?
- Ages 40 to 64 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Self Esteem, Psychological Well-being, Stress, Physiological
- What is being tested?
- Positive reinforcement method and Standard method
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 150 participants
- Where
- 1 siteSpain
- Study dates
- 26 Dec 2022to 1 Feb 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 40 to 64 years
- Women only
- Healthy volunteers accepted
- Adult
Who may be able to join
- Women between the ages of 40 and 65 years old
- Who use a facial cosmetic at least once a week.
Who cannot join
- Receiving oncological treatment at the time of participation in the study.
- Suffering acute infectious disease processes in the 3 months prior to the study or during the study period.
- Being diagnosed with some type of mental illness.
- Failure to sign the informed consent form.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Mental Beauty, the Unexplored Impact of Cosmetics on Mood, Personal Self-esteem, Perceived Stress, Mindfulness and Psychological Well-being.
The sociocultural pressure towards women's body image is one of the problems that today afflicts much of the female population. It is a reality that society exerts a strong pressure on body image, particularly on women.
The main objective of this study is to analyze the self-perception and self-esteem of people who apply a facial cosmetic. A convenience sample of 150 participants is estimated, who can be randomly included in one of the three groups with different interventions.
Read the detailed description
The aging process is something inherent in all people, causing biological and structural changes in our organism, being the skin the one that shows the first signs of this aging. Being healthy is no longer a desire and a natural aspiration of every person, but a kind of tyranny that has turned health into a duty that, according to the wellness industry, can only be satisfied through the consumption of certain commercial products and services. The cosmetic industry feeds us with false beliefs where perfection is something achievable, but many women do not want false promises from the cosmetic industry when they are aware that they have wrinkles. Such practices jeopardize physical health and impact mental health.
IIn line with this evolution, the researchers propose this study that suggests a relationship between the use of cosmetics, psychological well-being, stress and self-esteem of the people who consume them.
- Conditions
- Self Esteem, Psychological Well-being, Stress, Physiological, Mood
- Being tested
- Positive reinforcement method, Standard method
- Keywords
- beauty, Wellness, cosmetics, self-esteem, stress, Mental Beauty
- Medical subject headings
- Psychological Well-Being
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Positive reinforcement methodOther
A 30-minute talk based on mindfulness, positive thinking and teaching for the application of the cosmetic through positive messages (Ayuna method). Adapts the teachings of mindfulness to the field of beauty and stimulates the skin-brain connection through self-care. By applying cosmetics through intentional massages, with this technique is stimulated the brain in a positive positively in the general wellbeing.
The cosmetic is applied with a massage aimed at loving oneself, a ceremony for the skin and an invitation to enjoy the moment; positive messages are included during the application. In addition to favoring the penetration of the products, these maneuvers help to disconnect and achieve, in the long term, a healthier appearance. The technique consists of slow, intentional movements to create an ideal space to become aware of the present moment and draw a love story with oneself.
Standard methodOther
A 30-minute talk based on how to administer it according to the guidelines of general cosmetology, related to the use and application of the cream, following conventional techniques of the cosmetic industry, which focus on the application of the product in the areas of wrinkles or with more treatment needs: "anti-aging" "anti-stain" "anti-sagging" "anti-sagging" product, "anti-sagging" "anti-sagging" "anti-sagging" "anti-sagging" "anti-sagging" "anti-sagging" product. rejuvenating results to try to reduce the "skin years", reduce wrinkles, loss of firmness, flaccidity and spots.
| Study group | Role | What they receive |
|---|---|---|
| Positive reinforcement method | Experimental | The people who form the intervention groups will receive a facial cosmetic of natural components to be administered for 28 days, for which they will be given the cream.
The cream will be provided to the participants on the 1st day of the talk. The container containing the facial cosmetic will be applied twice a day, morning and evening.
Afterwards, in the "experimental" group, the participants will be given a talk on how to administer it according to the "positive reinforcement" method. Receives: Other: Positive reinforcement method |
| Standard method | Active comparator | The people who form the intervention groups will receive a facial cosmetic of natural components to be administered for 28 days, for which they will be given the cream.
The cream will be provided to the participants on the 1st day of the talk. The container containing the facial cosmetic will be applied twice a day, morning and evening. Receives: Other: Standard method |
| Control | No intervention | This group will continue to use their usual cosmetics and complete the questionnaire on the first day of the study and on the last day of the study (28 days later). |
What is being measured
The primary outcome is the main question the study is designed to answer.
Rosenberg Self-Esteem Scale (RSES)
The Rosenberg self-esteem scale is a test with good psychometric properties, and is one of the most widely used tests for the evaluation of self-esteem in clinical practice and scientific research. The Rosenberg Self-Esteem Scale (RSES) is made up of 10 items that refer to self-respect and self-acceptance rated on a 4-point Likert-type scale, ranging from 1 (totally disagree) to 4 (totally agree). Items 1, 3, 4, 7, and 10 are positively worded, and items 2, 5, 6, 8, and 9 negatively. Each dimension is made up of 6 items that are rated on a 99-point scale ranging from 1 (totally disagree with the item) to 99 (totally agree with the item). The higher the score, the higher the self-esteem.
Measured: 3 minutes
Perceived Stress Scale
The "Perceived Stress Scale" (PSS), constructed in its original version, has been the instrument most frequently used to study the relationship between stress and psychological health, The questions refer to feelings and thoughts during the last month. In each case, respondents are asked how often they felt a certain way on a five-point scale ranging from 0 'never' to 4 'very often'.
To calculate a total PSS score, the responses to the four positively stated items (items 4, 5, 7, and 8) must first be reversed (i.e., 0 => 4; 1 => 3; 2 => 2; 3 => 1 ; 4 => 0).
Then the PSS score is obtained by adding all the elements. Higher scores indicate higher levels of perceived stress.
Measured: 5 minutes
The Short Mood Introspection Scale
The Short Mood Introspection Scale. The scale consists of 16 adjectives that measure the mood of the current moment. Participants rate themselves on a four-point response scale (1 does not describe my mood at all, 2 describes my mood a little, 3 describes my mood well, 4 describes my mood very well). The higher the score, the greater the perception of mood.
Measured: 5 minutes
Psychological Well-Being Scale
Ryff (Psychological Well-Being Scale). It is made up of six dimensions: Self-acceptance, positive relationships, autonomy, mastery of the environment, purpose in life, personal growth. Scale made up of 39 items to which the participants responded using a Likert-type response format with sensitive sensors between 1 (totally disagree) and 6 (totally agree), for a maximum total of 234 points. Scores above 176 are indicative of elevated psychological well-being (BP); between 141 and 175 BP high; between 117 and 140 moderate BP points; and less than 116 BP points low.
Measured: 10 minutes
Descriptive questionnaire
Age, marital status, highest level of education, work, are you a health worker, do you work in the beauty and esthetics industry, level of income within the family unit.
Do you currently make use of regular facial treatment, at what age did you start using cosmetics for facial use, how many years have you been using facial cosmetics, when you buy your facial treatment cosmetics what do you take into account at the time of purchase, how do you feel if you think about your body, how do you feel if you think about your face, how do you feel if you think about your body, how do you feel if you think about your face, how do you feel if you think about your body, how do you feel if you think about your body, how do you feel if you think about your face?
Measured: 5 minutes
Secondary outcomes (1)
The abbreviated 5-factor mindfulness instrument FFMQ
The abbreviated 5-factor mindfulness instrument. The FFMQ is a self-report test made up of 39 items, which measures the general tendency to proceed with Mindfulness based on five skills: Observation, Description, Acting Consciously, Absence of Judgment and Absence of Reactivity.
There are two patterns of scoring involved in the Five Facet Mindfulness Test:
Direct Scoring - where the items are scored according to the Likert value (for example 1 would add a score of 1 and 4 adds a value of 4).
Reverse Scoring - where we score the items backward (for example, 1 adds a score of 5, 5 adds a score of 1, 4 would mean a score of 2, and likewise).
Summation of all the direct and reverse items adds up to the total value of the scale.
The responses on the scale are made on a 5-point Likert scale, and the sum of the forward and reverse scoring items gives the total score.
The five subscales of the test provide a meaningful estimate of how aware the respondent is at the moment.
Measured: 10 minutes
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Jul 2023
- Study start26 Dec 2022
- Primary completion31 Jan 2023
- Study completion1 Feb 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (8)Papers the sponsor has linked to this study.
- Other trials for Self EsteemStudies 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
- There are three arms, two of intervention and one control. Arm 1: intervention with fasting method Arm 2: Non-fasting method Arm 3: Control group
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 150 participants (actual)
Sponsor and investigators
- Lead sponsor
- Instituto de Investigación Sanitaria Aragón
- Sponsor type
- University, hospital or other
- Collaborators
- BIT BEAUTY SL.
- Responsible party
- Principal investigator, Yolanda Marcen Roman, Instituto de Investigación Sanitaria Aragón
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05945472
- Sponsor's protocol ID
- Beauty and wellness
- Status last verified
- Jul 2023
- First submitted
- 11 Jan 2023
- Last updated
- 20 Jul 2023
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Danthinne ES, Giorgianni FE, Austin SB, Rodgers RF. Beauty and the big business: A qualitative investigation of the development and implementation of the CVS Beauty Mark. Body Image. 2022 Jun;41:74-83. doi: 10.1016/j.bodyim.2022.01.012. Epub 2022 Feb 28.
PubMed 35240392Díaz Rojo, J. A., Y Morant Marco, R. (2007). El discurso crítico contra la <tiranía> del culto al cuerpo. Revista electrónica de estudios filológicos, (XIV), 1.
McLaren, L. Hardy, R. Y Gauvin, L. (2004). Positive and negative body-related comments and their relationship with body dissatisfaction in middle-aged women. Psychology & health ,2, 261-272.
Voegeli R, Schoop R, Prestat-Marquis E, Rawlings AV, Shackelford TK, Fink B. Cross-cultural perception of female facial appearance: A multi-ethnic and multi-centre study. PLoS One. 2021 Jan 22;16(1):e0245998. doi: 10.1371/journal.pone.0245998. eCollection 2021.
PubMed 33481957Little AC, Jones BC, DeBruine LM. Facial attractiveness: evolutionary based research. Philos Trans R Soc Lond B Biol Sci. 2011 Jun 12;366(1571):1638-59. doi: 10.1098/rstb.2010.0404.
PubMed 21536551Samson N, Fink B, Matts PJ. Visible skin condition and perception of human facial appearance. Int J Cosmet Sci. 2010 Jun;32(3):167-84. doi: 10.1111/j.1468-2494.2009.00535.x. Epub 2009 Nov 3.
PubMed 19889046Fares K, Hallit S, Haddad C, Akel M, Khachan T, Obeid S. Relationship Between Cosmetics Use, Self-Esteem, and Self-Perceived Attractiveness Among Lebanese Women. J Cosmet Sci. 2019 Jan/Feb;70(1):47-56.
PubMed 30856095Cohen S, Kamarck T, Mermelstein R. A global measure of perceived stress. J Health Soc Behav. 1983 Dec;24(4):385-96. No abstract available.
PubMed 6668417
Study at a glance
From the registry record, last updated by the sponsor on 20 Jul 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Mental Beauty, the Unexplored Impact of Cosmetics on Mood, Personal Self-esteem, Perceived Stress, Mindfulness and Psychological Well-being.
- ClinicalTrials.gov ID
- NCT05945472
- Acronym / sponsor ID
- Beauty and wellness
- Conditions
- Self Esteem, Psychological Well-being, Stress, Physiological, Mood
- Keywords
- beauty, Wellness, cosmetics, self-esteem, stress, Mental Beauty
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 150 participants (actual)
- Lead sponsor
- Instituto de Investigación Sanitaria AragónUniversity, hospital or other
- Collaborators
- BIT BEAUTY SL.
- Study start
- 26 Dec 2022 (actual)
- Primary completion
- 31 Jan 2023 (actual)
- Study completion
- 1 Feb 2023 (actual)
- First posted
- 14 Jul 2023 (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.
The sociocultural pressure towards women's body image is one of the problems that today afflicts much of the female population. It is a reality that society exerts a strong pressure on body image, particularly on women.
The main objective of this study is to analyze the self-perception and self-esteem of people who apply a facial cosmetic. A convenience sample of 150 participants is estimated, who can be randomly included in one of the three groups with different interventions.
Detailed description
The aging process is something inherent in all people, causing biological and structural changes in our organism, being the skin the one that shows the first signs of this aging. Being healthy is no longer a desire and a natural aspiration of every person, but a kind of tyranny that has turned health into a duty that, according to the wellness industry, can only be satisfied through the consumption of certain commercial products and services. The cosmetic industry feeds us with false beliefs where perfection is something achievable, but many women do not want false promises from the cosmetic industry when they are aware that they have wrinkles. Such practices jeopardize physical health and impact mental health.
IIn line with this evolution, the researchers propose this study that suggests a relationship between the use of cosmetics, psychological well-being, stress and self-esteem of the people who consume them.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 3
- Model description
- There are three arms, two of intervention and one control. Arm 1: intervention with fasting method Arm 2: Non-fasting method Arm 3: Control group
| Arm | Type | Receives |
|---|---|---|
| Positive reinforcement method | Experimental | Other: Positive reinforcement methodThe people who form the intervention groups will receive a facial cosmetic of natural components to be administered for 28 days, for which they will be given the cream. The cream will be provided to the participants on the 1st day of the talk. The container containing the facial cosmetic will be applied twice a day, morning and evening. Afterwards, in the "experimental" group, the participants will be given a talk on how to administer it according to the "positive reinforcement" method. |
| Standard method | Active comparator | Other: Standard methodThe people who form the intervention groups will receive a facial cosmetic of natural components to be administered for 28 days, for which they will be given the cream. The cream will be provided to the participants on the 1st day of the talk. The container containing the facial cosmetic will be applied twice a day, morning and evening. |
| Control | No intervention | –This group will continue to use their usual cosmetics and complete the questionnaire on the first day of the study and on the last day of the study (28 days later). |
Who may qualify
- Ages
- 40 to 64 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (2 listed)
- Women between the ages of 40 and 65 years old
- Who use a facial cosmetic at least once a week.
Key exclusion criteria (4 listed)
- Receiving oncological treatment at the time of participation in the study.
- Suffering acute infectious disease processes in the 3 months prior to the study or during the study period.
- Being diagnosed with some type of mental illness.
- Failure to sign the informed consent form.
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 |
|---|---|---|
| Positive reinforcement methodA 30-minute talk based on mindfulness, positive thinking and teaching for the application of the cosmetic through positive messages (Ayuna method). Adapts the teachings of mindfulness to the field of beauty and stimulates the skin-brain connection through self-care. By applying cosmetics through intentional massages, with this technique is stimulated the brain in a positive positively in the general wellbeing. The cosmetic is applied with a massage aimed at loving oneself, a ceremony for the skin and an invitation to enjoy the moment; positive messages are included during the application. In addition to favoring the penetration of the products, these maneuvers help to disconnect and achieve, in the long term, a healthier appearance. The technique consists of slow, intentional movements to create an ideal space to become aware of the present moment and draw a love story with oneself. | Other | Positive reinforcement method |
| Standard methodA 30-minute talk based on how to administer it according to the guidelines of general cosmetology, related to the use and application of the cream, following conventional techniques of the cosmetic industry, which focus on the application of the product in the areas of wrinkles or with more treatment needs: "anti-aging" "anti-stain" "anti-sagging" "anti-sagging" product, "anti-sagging" "anti-sagging" "anti-sagging" "anti-sagging" "anti-sagging" "anti-sagging" product. rejuvenating results to try to reduce the "skin years", reduce wrinkles, loss of firmness, flaccidity and spots. | Other | Standard method |
Primary outcome
Rosenberg Self-Esteem Scale (RSES)
Time frame: 3 minutes
The Rosenberg self-esteem scale is a test with good psychometric properties, and is one of the most widely used tests for the evaluation of self-esteem in clinical practice and scientific research. The Rosenberg Self-Esteem Scale (RSES) is made up of 10 items that refer to self-respect and self-acceptance rated on a 4-point Likert-type scale, ranging from 1 (totally disagree) to 4 (totally agree). Items 1, 3, 4, 7, and 10 are positively worded, and items 2, 5, 6, 8, and 9 negatively. Each dimension is made up of 6 items that are rated on a 99-point scale ranging from 1 (totally disagree with the item) to 99 (totally agree with the item). The higher the score, the higher the self-esteem.
Perceived Stress Scale
Time frame: 5 minutes
The "Perceived Stress Scale" (PSS), constructed in its original version, has been the instrument most frequently used to study the relationship between stress and psychological health, The questions refer to feelings and thoughts during the last month. In each case, respondents are asked how often they felt a certain way on a five-point scale ranging from 0 'never' to 4 'very often'. To calculate a total PSS score, the responses to the four positively stated items (items 4, 5, 7, and 8) must first be reversed (i.e., 0 => 4; 1 => 3; 2 => 2; 3 => 1 ; 4 => 0). Then the PSS score is obtained by adding all the elements. Higher scores indicate higher levels of perceived stress.
The Short Mood Introspection Scale
Time frame: 5 minutes
The Short Mood Introspection Scale. The scale consists of 16 adjectives that measure the mood of the current moment. Participants rate themselves on a four-point response scale (1 does not describe my mood at all, 2 describes my mood a little, 3 describes my mood well, 4 describes my mood very well). The higher the score, the greater the perception of mood.
Psychological Well-Being Scale
Time frame: 10 minutes
Ryff (Psychological Well-Being Scale). It is made up of six dimensions: Self-acceptance, positive relationships, autonomy, mastery of the environment, purpose in life, personal growth. Scale made up of 39 items to which the participants responded using a Likert-type response format with sensitive sensors between 1 (totally disagree) and 6 (totally agree), for a maximum total of 234 points. Scores above 176 are indicative of elevated psychological well-being (BP); between 141 and 175 BP high; between 117 and 140 moderate BP points; and less than 116 BP points low.
Descriptive questionnaire
Time frame: 5 minutes
Age, marital status, highest level of education, work, are you a health worker, do you work in the beauty and esthetics industry, level of income within the family unit. Do you currently make use of regular facial treatment, at what age did you start using cosmetics for facial use, how many years have you been using facial cosmetics, when you buy your facial treatment cosmetics what do you take into account at the time of purchase, how do you feel if you think about your body, how do you feel if you think about your face, how do you feel if you think about your body, how do you feel if you think about your face, how do you feel if you think about your body, how do you feel if you think about your body, how do you feel if you think about your face?
1 secondary outcome
The abbreviated 5-factor mindfulness instrument FFMQ
Time frame: 10 minutes
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 20 Jul 2023.
- Background: PubMed 35240392Danthinne ES, Giorgianni FE, Austin SB, Rodgers RF. Beauty and the big business: A qualitative investigation of the development and implementation of the CVS Beauty Mark. Body Image. 2022 Jun;41:74-83. doi: 10.1016/j.bodyim.2022.01.012. Epub 2022 Feb 28.
- BackgroundDíaz Rojo, J. A., Y Morant Marco, R. (2007). El discurso crítico contra la <tiranía> del culto al cuerpo. Revista electrónica de estudios filológicos, (XIV), 1.
- BackgroundMcLaren, L. Hardy, R. Y Gauvin, L. (2004). Positive and negative body-related comments and their relationship with body dissatisfaction in middle-aged women. Psychology & health ,2, 261-272.
- Background: PubMed 33481957Voegeli R, Schoop R, Prestat-Marquis E, Rawlings AV, Shackelford TK, Fink B. Cross-cultural perception of female facial appearance: A multi-ethnic and multi-centre study. PLoS One. 2021 Jan 22;16(1):e0245998. doi: 10.1371/journal.pone.0245998. eCollection 2021.
- Background: PubMed 21536551Little AC, Jones BC, DeBruine LM. Facial attractiveness: evolutionary based research. Philos Trans R Soc Lond B Biol Sci. 2011 Jun 12;366(1571):1638-59. doi: 10.1098/rstb.2010.0404.
- Background: PubMed 19889046Samson N, Fink B, Matts PJ. Visible skin condition and perception of human facial appearance. Int J Cosmet Sci. 2010 Jun;32(3):167-84. doi: 10.1111/j.1468-2494.2009.00535.x. Epub 2009 Nov 3.
- Background: PubMed 30856095Fares K, Hallit S, Haddad C, Akel M, Khachan T, Obeid S. Relationship Between Cosmetics Use, Self-Esteem, and Self-Perceived Attractiveness Among Lebanese Women. J Cosmet Sci. 2019 Jan/Feb;70(1):47-56.
- Background: PubMed 6668417Cohen S, Kamarck T, Mermelstein R. A global measure of perceived stress. J Health Soc Behav. 1983 Dec;24(4):385-96. No abstract available.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Positive reinforcement method and Standard method in people with Self Esteem and Psychological Well-being, run by Instituto de Investigación Sanitaria Aragón at 1 site in Spain.
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 2 inclusion and 4 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 20 Jul 2023. 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 Spain. 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?
Rosenberg Self-Esteem Scale (RSES) (time frame: 3 minutes). The study lists 5 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 NCT05945472, which also lists 8 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 Jul 2023; AzTrials last refreshed its copy on 7 Nov 2026.