Healthy VolunteersNCT01821534

Reliability of a Masseter Muscle Prominence Scale and Lower Facial Shape Classification

An observational study of Healthy Volunteers, run by Allergan at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Trial summary

This study will evaluate the inter-rater and intra-rater reliability of a Masseter Muscle Prominence Scale for evaluating a patient's muscle prominence and a Lower Shape Classification for evaluating a patient's lower facial shape. Read more about this study

Who is it for?: Ages 18 years and olderHealthy volunteers can take part
Conditions the study is for: Healthy Volunteers
How many people: 201 participants
Where: 1 siteUnited States
Study dates: Mar 2013to May 2013
Phase: Observational
Are there results?: Yes, posted in the registrySummary in the doctors' view

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: Healthy Volunteers

Who may be able to join

-sufficient visual acuity without the use of glasses or with contact lenses to self-assess lower facial shape in a mirror

Who cannot join

infection of the mouth or gums, or facial skin infection requiring antibiotics
planned dental or facial procedure
unwillingness to be photographed and have the photos used for research, training, or educational purposes

Trial locations and contacts

1 site in 1 country.

United States1 site

Study site
Newport Beach, California

Other trials in United States

About this study

Conditions: Healthy Volunteers
Being tested: No Intervention

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

No InterventionOther
No treatment (intervention) was administered.

Study groups in NCT01821534
Study group	Role	What they receive
All Participants		Healthy volunteers. No treatment (intervention) was administered. Receives: Other: No Intervention

What is being measured

The primary outcome is the main question the study is designed to answer.

Inter-rater Reliability Using a Masseter Muscle Prominence Scale (MMPS)
The MMPS is an ordinal tool to assess the masseter muscle prominence (jaw muscle) for each side of the face from 1=minimal to 5=very marked. Inter-rater (among raters) reliability was calculated separately for the left and right side of the face using Kendall's coefficient of concordance (Kendall's W). Kendall W statistics overall for the left and right sides of the face were derived using the average of assessment 1 and assessment 2 rounded to the nearest whole integer for each subject and each clinician. A total of 8 physicians rated each subject. The degree of agreement of the point estimates of Kendall's W was interpreted according to the reference range scale that was pre-defined as: ≤0: poor, >0 to ≤0.2: slight, >0.2 to ≤0.4: fair, >0.4 to ≤0.6: moderate, >0.6 to ≤0.8: substantial, and >0.8 to ≤1.0: almost perfect. The 95% confidence interval for Kendall's W is provided.
Measured: Day 1
Intra-rater Reliability Using a MMPS
The MMPS is an ordinal tool to assess the masseter muscle prominence (jaw muscle) for each side of the face from 1 = minimal to 5 = very marked. Intra-rater (within raters) reliability was calculated separately for the left and right side of the face using weighted Kappa statistics. Weighted Kappa statistics were calculated for each of the 8 physician raters. The overall intra-rater agreement for Kappa statistics for all raters combined was estimated by pooling Kappa statistics for each rater using a chi-square statistic. The degree of agreement of the point estimates of Kappa statistics was interpreted according to the reference range scale that was pre-defined as: ≤0: poor, >0 to ≤0.2: slight, >0.2 to ≤0.4: fair, >0.4 to ≤0.6: moderate, >0.6 to ≤0.8: substantial, and >0.8 to ≤1.0: almost perfect. The 95% confidence interval for Kappa statistics is provided.
Measured: Day 1
Inter-rater Reliability Using a Lower Facial Shape Classification (LFSC)
The LFSC is a qualitative tool to assess facial shape into one of 5 categories (A, B, C, D, and E). Inter-rater (among raters) reliability was calculated using Kappa statistics. Kappa statistics were calculated for each of the 5 facial categories. A total of 8 physicians rated each subject. The overall inter-rater agreement for Kappa statistics for all categories combined was estimated by pooling Kappa statistics for each category using a chi-square statistic. The degree of agreement of the point estimates of Kappa statistics was interpreted according to the reference range scale that was pre-defined as: ≤0: poor, >0 to ≤0.2: slight, >0.2 to ≤0.4: fair, >0.4 to ≤0.6: moderate, >0.6 to ≤0.8: substantial, and >0.8 to ≤1.0: almost perfect. The 95% confidence interval for Kappa statistics is provided.
Measured: Day 1
Intra-rater Reliability Using a LFSC
The LFSC is a qualitative tool to assess facial shape into one of 5 categories (A, B, C, D, and E). Intra-rater (within raters) reliability was calculated using Kappa statistics. Kappa statistics were calculated for each of the 8 physician raters. The overall intra-rater agreement for Kappa statistics for all raters combined was estimated by pooling Kappa statistics for each rater using a chi-square statistic. The degree of agreement of the point estimates of Kappa statistics was interpreted according to the reference range scale that was pre-defined as: ≤0: poor, >0 to ≤0.2: slight, >0.2 to ≤0.4: fair, >0.4 to ≤0.6: moderate, >0.6 to ≤0.8: substantial, and >0.8 to ≤1.0: almost perfect. The 95% confidence interval for Kappa statistics is provided.
Measured: Day 1

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

Mar 2013May 2013

First posted1 Apr 2013 (estimated)
Study startMar 2013
Primary completionMay 2013
Study completionMay 2013

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Other trials for Healthy VolunteersStudies 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: Observational
Observational model: Cohort
Time perspective: Prospective
Enrolment: 201 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT01821534
Sponsor's protocol ID: 191622-128
Status last verified: Mar 2014
First submitted: 25 Mar 2013
Last updated: 30 Apr 2014
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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All Healthy Volunteers trials

Study at a glance

From the registry record, last updated by the sponsor on 30 Apr 2014. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Reliability of a Masseter Muscle Prominence Scale and Lower Facial Shape Classification
ClinicalTrials.gov ID: NCT01821534
Acronym / sponsor ID: 191622-128
Conditions: Healthy Volunteers
Study type: Observational
Recruitment status: Completed
Enrolment: 201 participants (actual)
Lead sponsor: AllerganIndustry (pharma, biotech, devices)
Study start: Mar 2013
Primary completion: May 2013 (actual)
Study completion: May 2013 (actual)
First posted: 1 Apr 2013 (estimated)
Results: Posted 30 Apr 2014

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Study design

Observational model: Cohort
Time perspective: Prospective
Number of arms: 1

Arm	Type	Receives
All Participants	–	Other: No InterventionHealthy volunteers. No treatment (intervention) was administered.

Who may qualify

Ages: 18 years and older
Sex: All
Healthy volunteers: Accepted
Age groups: Adult, Older adult
Study population: Healthy Volunteers

Key inclusion criteria (1 listed)

-sufficient visual acuity without the use of glasses or with contact lenses to self-assess lower facial shape in a mirror

Key exclusion criteria (3 listed)

infection of the mouth or gums, or facial skin infection requiring antibiotics
planned dental or facial procedure
unwillingness to be photographed and have the photos used for research, training, or educational purposes

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
No InterventionNo treatment (intervention) was administered.	Other	All Participants

Primary outcome

Inter-rater Reliability Using a Masseter Muscle Prominence Scale (MMPS)
Time frame: Day 1
The MMPS is an ordinal tool to assess the masseter muscle prominence (jaw muscle) for each side of the face from 1=minimal to 5=very marked. Inter-rater (among raters) reliability was calculated separately for the left and right side of the face using Kendall's coefficient of concordance (Kendall's W). Kendall W statistics overall for the left and right sides of the face were derived using the average of assessment 1 and assessment 2 rounded to the nearest whole integer for each subject and each clinician. A total of 8 physicians rated each subject. The degree of agreement of the point estimates of Kendall's W was interpreted according to the reference range scale that was pre-defined as: ≤0: poor, >0 to ≤0.2: slight, >0.2 to ≤0.4: fair, >0.4 to ≤0.6: moderate, >0.6 to ≤0.8: substantial, and >0.8 to ≤1.0: almost perfect. The 95% confidence interval for Kendall's W is provided.
Intra-rater Reliability Using a MMPS
Time frame: Day 1
The MMPS is an ordinal tool to assess the masseter muscle prominence (jaw muscle) for each side of the face from 1 = minimal to 5 = very marked. Intra-rater (within raters) reliability was calculated separately for the left and right side of the face using weighted Kappa statistics. Weighted Kappa statistics were calculated for each of the 8 physician raters. The overall intra-rater agreement for Kappa statistics for all raters combined was estimated by pooling Kappa statistics for each rater using a chi-square statistic. The degree of agreement of the point estimates of Kappa statistics was interpreted according to the reference range scale that was pre-defined as: ≤0: poor, >0 to ≤0.2: slight, >0.2 to ≤0.4: fair, >0.4 to ≤0.6: moderate, >0.6 to ≤0.8: substantial, and >0.8 to ≤1.0: almost perfect. The 95% confidence interval for Kappa statistics is provided.
Inter-rater Reliability Using a Lower Facial Shape Classification (LFSC)
Time frame: Day 1
The LFSC is a qualitative tool to assess facial shape into one of 5 categories (A, B, C, D, and E). Inter-rater (among raters) reliability was calculated using Kappa statistics. Kappa statistics were calculated for each of the 5 facial categories. A total of 8 physicians rated each subject. The overall inter-rater agreement for Kappa statistics for all categories combined was estimated by pooling Kappa statistics for each category using a chi-square statistic. The degree of agreement of the point estimates of Kappa statistics was interpreted according to the reference range scale that was pre-defined as: ≤0: poor, >0 to ≤0.2: slight, >0.2 to ≤0.4: fair, >0.4 to ≤0.6: moderate, >0.6 to ≤0.8: substantial, and >0.8 to ≤1.0: almost perfect. The 95% confidence interval for Kappa statistics is provided.
Intra-rater Reliability Using a LFSC
Time frame: Day 1
The LFSC is a qualitative tool to assess facial shape into one of 5 categories (A, B, C, D, and E). Intra-rater (within raters) reliability was calculated using Kappa statistics. Kappa statistics were calculated for each of the 8 physician raters. The overall intra-rater agreement for Kappa statistics for all raters combined was estimated by pooling Kappa statistics for each rater using a chi-square statistic. The degree of agreement of the point estimates of Kappa statistics was interpreted according to the reference range scale that was pre-defined as: ≤0: poor, >0 to ≤0.2: slight, >0.2 to ≤0.4: fair, >0.4 to ≤0.6: moderate, >0.6 to ≤0.8: substantial, and >0.8 to ≤1.0: almost perfect. The 95% confidence interval for Kappa statistics is provided.

Results and safety

Results posted to the registry on 30 Apr 2014, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
All Participants	201	201

Primary outcome: Inter-rater Reliability Using a Masseter Muscle Prominence Scale (MMPS)

Time frame: Day 1. Number (95% Confidence Interval). Unit: Kendall's W

Measure	All Participants n = 201
Left Side	0.728 (0.677 to 0.786)
Right Side	0.711 (0.661 to 0.767)

Population analysed: Reliability population: all subjects with at least assessment 1 performed by at least 1 in-person rater on day 1

Primary outcome: Intra-rater Reliability Using a MMPS

Time frame: Day 1. Number (95% Confidence Interval). Unit: Kappa statistics

Measure	All Participants n = 201
Left Side	0.634 (0.607 to 0.660)
Right Side	0.638 (0.611 to 0.665)

Population analysed: Reliability population: all subjects with at least assessment 1 performed by at least 1 in-person rater on day 1

Primary outcome: Inter-rater Reliability Using a Lower Facial Shape Classification (LFSC)

Time frame: Day 1. Number (95% Confidence Interval). Unit: Kappa Statistics

Measure	All Participants n = 201
Assessment 1	0.358 (0.343 to 0.372)
Assessment 2	0.352 (0.337 to 0.367)

Population analysed: Reliability population: all subjects with at least assessment 1 performed by at least 1 in-person rater on day 1

Primary outcome: Intra-rater Reliability Using a LFSC

Time frame: Day 1. Number (95% Confidence Interval). Unit: Kappa statistics

Measure	All Participants n = 201
Value	0.658 (0.629 to 0.686)

Population analysed: Reliability population: all subjects with at least assessment 1 performed by at least 1 in-person rater on day 1

Adverse events

Time frame: Adverse events (AEs) were collected during the study period (Screening to Day 1).. Other adverse events reported at 5% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
All Participants	0 of 201 (0%)	0 of 201 (0%)	Not reported

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 30 Apr 2014.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.

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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.

Medical Director study director

Allergan

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

An observational study of Healthy Volunteers, run by Allergan 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 1 inclusion and 3 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 30 Apr 2014. 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. 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?

Yes. Results are posted in the registry (first posted 30 Apr 2014). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

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?

Inter-rater Reliability Using a Masseter Muscle Prominence Scale (MMPS) (time frame: Day 1). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT01821534.

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 30 Apr 2014.