Cosmetic Treatment WishNCT07687030
Quality of Life After Cosmetic Treatments
An observational study of Cosmetic Treatment Wish, run by Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA).
Trial summary
Prospective cohort study, investigating the pre-post treatment effect of cosmetic injectable and surgical treatments on quality of life (primary outcome measure: FACE-Q Psychological, secondary outcome measure: FACE-Q Social), compared with a non-treated control group. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Cosmetic Treatment Wish
- How many people
- 1,080 participants
- Where
- No sites listed yet
- Study dates
- 1 Dec 2026to 1 Jan 2028
- How long will I take part?
- 1 Year
- Phase
- Observational
- 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 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: Clients seeking cosmetic treatments, who have already booked an appointment for consultation and/or treatment at a Dutch clinic.
Who may be able to join
- Clients who have booked a cosmetic treatment (injectables or surgery) in one of the contributing clinics in the Netherlands
Who cannot join
- Regular contra-indications as per clinic protocol / physician judgment
About this study
Official title: Quality of Life After Cosmetic Treatments: a Prospective, Controlled Cohort Study
Prospective cohort study, investigating the pre-post treatment effect of cosmetic injectable and surgical treatments on quality of life (primary outcome measure: FACE-Q Psychological, secondary outcome measure: FACE-Q Social), compared with a non-treated control group. Propensity score analysis is used to reduce confounding by indication.
Read the detailed description
Methods
Study design and setting
This is a prospective controlled nationwide multicenter cohort study with repeated measurements in adults receiving cosmetic treatment at a chain of cosmetic clinics in the Netherlands and untreated controls. The study is designed to evaluate changes in quality of life following cosmetic treatment over a follow-up period (botulinum toxin: 2 months; hyaluronic acid filler: 3 months; surgery: 1 year). Untreated controls are sisters of treated female participants and were recruited to provide a comparison group with partial genetic and socio-economic similarity. To reduce seasonal and broader temporal influences on quality of life, controls complete the baseline questionnaire within the same calendar start month and year as the corresponding treated participant.
The study includes a broad overall treated cohort and prespecified treatment strata. The primary comparison is treated participants versus untreated controls. Secondary comparisons are performed within treatment classes, and tertiary comparisons within individual treatment groups.
Participants
Eligible treated participants are adult clients who booked a cosmetic treatment appointment and are invited to participate before treatment. Eligible controls are untreated sisters of female treated participants. Participants are included if they complete both the baseline and the follow-up questionnaire. Treated participants are classified according to the treatment received during the observation window.
Treatment groups
Treatment exposure is classified using a prespecified dropdown list. These categories are grouped into clinically relevant strata for analysis.
The individual treatment options are:
botulinum toxin, glabella/frown; botulinum toxin, crow's feet; botulinum toxin, forehead; botulinum toxin, masseters; hyaluronic acid filler, lips; hyaluronic acid filler, zygoma; hyaluronic acid filler, jawline and/or chin; hyaluronic acid filler, marionet lines and/or nasolabial; surgery, upper blepharoplasty; surgery, labiaplasty; surgery, breast augmentation; and surgery, liposuction.
For hierarchical analyses, these are aggregated into the treatment classes botulinum toxin, hyaluronic acid filler, and surgery.
Procedures
Treated participants receive an invitation by their treating doctor to complete an online baseline questionnaire before treatment and an online follow-up questionnaire months later. Untreated controls completed the same questionnaires with follow-up questionnaires after 2, 3 and 12 months, without undergoing cosmetic treatment during the study period. Baseline data include demographic, socioeconomic, prior cosmetic treatment, psychological, and treatment-selection variables.
Age (continuous)
Sex at birth (male / female / other)
Highest completed educational level (elementary / high school / MBO / HBO / WO)
SES-WOA (PC4 postal code, CBS data)
Previous cosmetic injectables (no / yes, past 2 years / yes, over 2 years ago)
Previous cosmetic surgery
(no / yes, past 5 years / yes, over 5 years ago) Use of psychotropic medication (antidepressants; antipsychotics; sedatives/anxiolytics: yes / no)
Preoccupation with appearance (Dutch question: "Do you spend a lot of time thinking about an imperfection or shortcoming in your appearance?" (very much / quite a lot / not at all / a little)
Relationship status (yes / no)
At follow-up, treated participants also report which treatment they had undergone in the previous months.
Outcomes
The primary outcome measures are change in FACE-Q Psychological Wellbeing and the secondary outcome is FACE-Q Social Function from baseline to 2-month follow-up. Both questionnaires are administered in Dutch at baseline and follow-up.
FACE-Q Social Function consists of 8 items and FACE-Q Psychological Wellbeing of 10 items. Item responses are coded according to the Dutch response categories and summed or otherwise transformed according to the questionnaire scoring rules. For the main analyses, the baseline and follow-up scores of each FACE-Q scale are used.
Baseline covariates
Prespecified baseline covariates are selected to capture major determinants of treatment selection and potential confounding by indication. These are:
age, modeled continuously; sex at birth; relationship status; highest completed educational level; area-level socioeconomic status based on SES-WOA linked to four-digit postcode; history of prior cosmetic injectables; history of prior cosmetic surgery; psychopharmacological medication use, defined as use of medication for anxiety, depression, psychosis, or sleep problems; and appearance-related preoccupation.
In addition, baseline FACE-Q Psychological Wellbeing and baseline FACE-Q Social Function scores are included in the outcome models.
Statistical analysis
Baseline characteristics are summarized descriptively for treated participants and untreated controls.
To reduce confounding by indication, propensity score matching is used to estimate the average treatment effect on the treated. For each comparison, the propensity score is defined as the probability of undergoing the treatment of interest conditional on the prespecified baseline covariates. Propensity scores are estimated using logistic regression, with treatment status as the dependent variable and baseline covariates as independent variables.
Each treatment comparison are treated as a separate target trial emulation. Analyses are conducted hierarchically across three prespecified strata: any cosmetic treatment versus untreated controls; treatment class versus untreated controls, including surgery, botulinum toxin, and hyaluronic acid fillers; and individual treatment groups versus untreated controls.
Propensity score matching is performed separately for each comparison using nearest-neighbour matching without replacement. Both 1:1 and 1:2 matching are considered. A caliper width of less than 0.2 standard deviations of the logit of the propensity score is applied. A maximum of 5% unmatched treated participants is allowed. The final matching specification is selected based on post-matching balance.
Matching is considered successful if all absolute standardized mean differences were less than 0.20 and variance ratios were between 0.90 and 1.10. Among successful specifications, the configuration with the best overall covariate balance will be selected. For 1:2 matching, matching weights generated by the MatchIt package are used where applicable when not all treated participants received two matched controls.
After matching, treatment effects are estimated using weighted linear regression models with robust standard errors. For each FACE-Q outcome, the follow-up score is modeled as the dependent variable, with treatment group as the main independent variable and the corresponding baseline FACE-Q score included as a covariate. This analysis of covariance approach is chosen to improve precision and account for residual baseline differences after matching. Effect estimates is reported as adjusted mean differences with 95% confidence intervals.
Formal multiplicity correction will not be applied across the separate, non-nested target trial emulations, because each addressed a distinct causal question. To aid interpretation, a hierarchical Benjamini-Hochberg procedure across the three prespecified strata will be presented descriptively only. Confidence intervals and inference thresholds were not adjusted. Statistical significance is defined as a two-sided p value of 0.05 or lower.
Sensitivity analyses are performed to assess robustness. First, results are compared across the 1:1 and 1:2 matching strategies. Second, post-matching balance diagnostics will be evaluated for each analysis. Third, E-values were calculated for the estimated treatment effects as an indication of sensitivity to unmeasured confounding.
All analyses will be performed in R using the MatchIt, mice, and survey packages.
Ethics
The study was reviewed by the relevant institutional review board and was judged exempt from the Medical Research Involving Human Subjects Act (niet-WMO-plichtig). All participants provide informed consent before participation.
Reporting
The study is reported in accordance with the STROBE statement and the RECORD guidelines.
- Conditions
- Cosmetic Treatment Wish
- Keywords
- quality of life, botulinum neurotoxin type A, hyaluronic acid filler, dermal fillers, cosmetic surgery, aesthetics, cosmetic medicine
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| botulinum toxin, glabella/frown | N=90 | |
| botulinum toxin, crow's feet | N=90 | |
| botulinum toxin, forehead | N=90 | |
| botulinum toxin, masseters | N=90 | |
| hyaluronic acid filler, lips | N=90 | |
| hyaluronic acid filler, zygoma | N=90 | |
| hyaluronic acid filler, jawline and/or chin | N=90 | |
| hyaluronic acid filler, marionet lines and/or nasolabial | N=90 | |
| surgery, upper blepharoplasty | N=90 | |
| surgery, labiaplasty | N=90 | |
| surgery, breast augmentation | N=90 | |
| surgery, liposuction | N=90 | |
| Untreated controls | Sisters of treated participants (N=90) |
What is being measured
The primary outcome is the main question the study is designed to answer.
FACE-Q Psychological Wellbeing
Change in score from baseline to follow-up
Measured: Botulinum neurtoxin type A: From baseline to 2-months follow-up Hyaluronic acid dermal fillers: From baseline to 3-months follow-up Surgery: From baseline to 12-months follow-up
Secondary outcomes (1)
FACE-Q Social function
Change in score from baseline to follow-up
Measured: Botulinum neurtoxin type A: From baseline to 2-months follow-up Hyaluronic acid dermal fillers: From baseline to 3-months follow-up Surgery: From baseline to 12-months follow-up
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Jul 2026
- Study start1 Dec 2026 (estimated)
- Primary completion1 Dec 2027 (estimated)
- Study completion1 Jan 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cosmetic Treatment WishStudies of the same condition, open and under way.
- More trials run by Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 1,080 participants (estimated)
- Target duration
- 1 Year
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Prof. dr. J. de Lange, MD DMD, Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07687030
- Sponsor's protocol ID
- 2023.0499
- Status last verified
- Jun 2026
- First submitted
- 22 Jun 2026
- Last updated
- 7 Jul 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 7 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Quality of Life After Cosmetic Treatments: a Prospective, Controlled Cohort Study
- ClinicalTrials.gov ID
- NCT07687030
- Acronym / sponsor ID
- 2023.0499
- Conditions
- Cosmetic Treatment Wish
- Keywords
- quality of life, botulinum neurotoxin type A, hyaluronic acid filler, dermal fillers, cosmetic surgery, aesthetics, cosmetic medicine
- Study type
- Observational
- Recruitment status
- Not yet recruiting
- Enrolment
- 1,080 participants (estimated)
- Lead sponsor
- Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)University, hospital or other
- Study start
- 1 Dec 2026 (estimated)
- Primary completion
- 1 Dec 2027 (estimated)
- Study completion
- 1 Jan 2028 (estimated)
- First posted
- 7 Jul 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.
Prospective cohort study, investigating the pre-post treatment effect of cosmetic injectable and surgical treatments on quality of life (primary outcome measure: FACE-Q Psychological, secondary outcome measure: FACE-Q Social), compared with a non-treated control group. Propensity score analysis is used to reduce confounding by indication.
Detailed description
Methods
Study design and setting
This is a prospective controlled nationwide multicenter cohort study with repeated measurements in adults receiving cosmetic treatment at a chain of cosmetic clinics in the Netherlands and untreated controls. The study is designed to evaluate changes in quality of life following cosmetic treatment over a follow-up period (botulinum toxin: 2 months; hyaluronic acid filler: 3 months; surgery: 1 year). Untreated controls are sisters of treated female participants and were recruited to provide a comparison group with partial genetic and socio-economic similarity. To reduce seasonal and broader temporal influences on quality of life, controls complete the baseline questionnaire within the same calendar start month and year as the corresponding treated participant.
The study includes a broad overall treated cohort and prespecified treatment strata. The primary comparison is treated participants versus untreated controls. Secondary comparisons are performed within treatment classes, and tertiary comparisons within individual treatment groups.
Participants
Eligible treated participants are adult clients who booked a cosmetic treatment appointment and are invited to participate before treatment. Eligible controls are untreated sisters of female treated participants. Participants are included if they complete both the baseline and the follow-up questionnaire. Treated participants are classified according to the treatment received during the observation window.
Treatment groups
Treatment exposure is classified using a prespecified dropdown list. These categories are grouped into clinically relevant strata for analysis.
The individual treatment options are:
botulinum toxin, glabella/frown; botulinum toxin, crow's feet; botulinum toxin, forehead; botulinum toxin, masseters; hyaluronic acid filler, lips; hyaluronic acid filler, zygoma; hyaluronic acid filler, jawline and/or chin; hyaluronic acid filler, marionet lines and/or nasolabial; surgery, upper blepharoplasty; surgery, labiaplasty; surgery, breast augmentation; and surgery, liposuction.
For hierarchical analyses, these are aggregated into the treatment classes botulinum toxin, hyaluronic acid filler, and surgery.
Procedures
Treated participants receive an invitation by their treating doctor to complete an online baseline questionnaire before treatment and an online follow-up questionnaire months later. Untreated controls completed the same questionnaires with follow-up questionnaires after 2, 3 and 12 months, without undergoing cosmetic treatment during the study period. Baseline data include demographic, socioeconomic, prior cosmetic treatment, psychological, and treatment-selection variables.
Age (continuous)
Sex at birth (male / female / other)
Highest completed educational level (elementary / high school / MBO / HBO / WO)
SES-WOA (PC4 postal code, CBS data)
Previous cosmetic injectables (no / yes, past 2 years / yes, over 2 years ago)
Previous cosmetic surgery
(no / yes, past 5 years / yes, over 5 years ago) Use of psychotropic medication (antidepressants; antipsychotics; sedatives/anxiolytics: yes / no)
Preoccupation with appearance (Dutch question: "Do you spend a lot of time thinking about an imperfection or shortcoming in your appearance?" (very much / quite a lot / not at all / a little)
Relationship status (yes / no)
At follow-up, treated participants also report which treatment they had undergone in the previous months.
Outcomes
The primary outcome measures are change in FACE-Q Psychological Wellbeing and the secondary outcome is FACE-Q Social Function from baseline to 2-month follow-up. Both questionnaires are administered in Dutch at baseline and follow-up.
FACE-Q Social Function consists of 8 items and FACE-Q Psychological Wellbeing of 10 items. Item responses are coded according to the Dutch response categories and summed or otherwise transformed according to the questionnaire scoring rules. For the main analyses, the baseline and follow-up scores of each FACE-Q scale are used.
Baseline covariates
Prespecified baseline covariates are selected to capture major determinants of treatment selection and potential confounding by indication. These are:
age, modeled continuously; sex at birth; relationship status; highest completed educational level; area-level socioeconomic status based on SES-WOA linked to four-digit postcode; history of prior cosmetic injectables; history of prior cosmetic surgery; psychopharmacological medication use, defined as use of medication for anxiety, depression, psychosis, or sleep problems; and appearance-related preoccupation.
In addition, baseline FACE-Q Psychological Wellbeing and baseline FACE-Q Social Function scores are included in the outcome models.
Statistical analysis
Baseline characteristics are summarized descriptively for treated participants and untreated controls.
To reduce confounding by indication, propensity score matching is used to estimate the average treatment effect on the treated. For each comparison, the propensity score is defined as the probability of undergoing the treatment of interest conditional on the prespecified baseline covariates. Propensity scores are estimated using logistic regression, with treatment status as the dependent variable and baseline covariates as independent variables.
Each treatment comparison are treated as a separate target trial emulation. Analyses are conducted hierarchically across three prespecified strata: any cosmetic treatment versus untreated controls; treatment class versus untreated controls, including surgery, botulinum toxin, and hyaluronic acid fillers; and individual treatment groups versus untreated controls.
Propensity score matching is performed separately for each comparison using nearest-neighbour matching without replacement. Both 1:1 and 1:2 matching are considered. A caliper width of less than 0.2 standard deviations of the logit of the propensity score is applied. A maximum of 5% unmatched treated participants is allowed. The final matching specification is selected based on post-matching balance.
Matching is considered successful if all absolute standardized mean differences were less than 0.20 and variance ratios were between 0.90 and 1.10. Among successful specifications, the configuration with the best overall covariate balance will be selected. For 1:2 matching, matching weights generated by the MatchIt package are used where applicable when not all treated participants received two matched controls.
After matching, treatment effects are estimated using weighted linear regression models with robust standard errors. For each FACE-Q outcome, the follow-up score is modeled as the dependent variable, with treatment group as the main independent variable and the corresponding baseline FACE-Q score included as a covariate. This analysis of covariance approach is chosen to improve precision and account for residual baseline differences after matching. Effect estimates is reported as adjusted mean differences with 95% confidence intervals.
Formal multiplicity correction will not be applied across the separate, non-nested target trial emulations, because each addressed a distinct causal question. To aid interpretation, a hierarchical Benjamini-Hochberg procedure across the three prespecified strata will be presented descriptively only. Confidence intervals and inference thresholds were not adjusted. Statistical significance is defined as a two-sided p value of 0.05 or lower.
Sensitivity analyses are performed to assess robustness. First, results are compared across the 1:1 and 1:2 matching strategies. Second, post-matching balance diagnostics will be evaluated for each analysis. Third, E-values were calculated for the estimated treatment effects as an indication of sensitivity to unmeasured confounding.
All analyses will be performed in R using the MatchIt, mice, and survey packages.
Ethics
The study was reviewed by the relevant institutional review board and was judged exempt from the Medical Research Involving Human Subjects Act (niet-WMO-plichtig). All participants provide informed consent before participation.
Reporting
The study is reported in accordance with the STROBE statement and the RECORD guidelines.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 1 Year
- Number of arms
- 13
| Arm | Type | Receives |
|---|---|---|
| botulinum toxin, glabella/frown | – | –N=90 |
| botulinum toxin, crow's feet | – | –N=90 |
| botulinum toxin, forehead | – | –N=90 |
| botulinum toxin, masseters | – | –N=90 |
| hyaluronic acid filler, lips | – | –N=90 |
| hyaluronic acid filler, zygoma | – | –N=90 |
| hyaluronic acid filler, jawline and/or chin | – | –N=90 |
| hyaluronic acid filler, marionet lines and/or nasolabial | – | –N=90 |
| surgery, upper blepharoplasty | – | –N=90 |
| surgery, labiaplasty | – | –N=90 |
| surgery, breast augmentation | – | –N=90 |
| surgery, liposuction | – | –N=90 |
| Untreated controls | – | –Sisters of treated participants (N=90) |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Clients seeking cosmetic treatments, who have already booked an appointment for consultation and/or treatment at a Dutch clinic.
Key inclusion criteria (1 listed)
- Clients who have booked a cosmetic treatment (injectables or surgery) in one of the contributing clinics in the Netherlands
Key exclusion criteria (1 listed)
- Regular contra-indications as per clinic protocol / physician judgment
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
FACE-Q Psychological Wellbeing
Time frame: Botulinum neurtoxin type A: From baseline to 2-months follow-up Hyaluronic acid dermal fillers: From baseline to 3-months follow-up Surgery: From baseline to 12-months follow-up
Change in score from baseline to follow-up
1 secondary outcome
FACE-Q Social function
Time frame: Botulinum neurtoxin type A: From baseline to 2-months follow-up Hyaluronic acid dermal fillers: From baseline to 3-months follow-up Surgery: From baseline to 12-months follow-up
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 7 Jul 2026.
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.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
An observational study of Cosmetic Treatment Wish, run by Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA).
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 1 inclusion and 1 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: opening soon, as of the sponsor's last update on 7 Jul 2026. Status can change between updates, so confirm with the study contact before making plans.
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?
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?
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?
FACE-Q Psychological Wellbeing (time frame: Botulinum neurtoxin type A: From baseline to 2-months follow-up Hyaluronic acid dermal fillers: From baseline to 3-months follow-up Surgery: From baseline to 12-months follow-up). 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 7 Jul 2026.