Facial RhytidesNCT01600729

Reliability of the Facial Wrinkle Scale in Japanese Subjects

An observational study of Facial Rhytides, run by Allergan at 1 site in Japan.

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 the Facial Wrinkle Scale with Asian Photonumeric Guide (FWS-A) in Japanese subjects. Read more about this study

Who is it for?: Ages 20 to 64 yearsHealthy volunteers can take part
Conditions the study is for: Facial Rhytides
How many people: 66 participants
Where: 1 siteJapan
Study dates: Jun 2012to Jul 2012
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 20 to 64 years
All sexes
Healthy volunteers accepted
Adult

Study population: Subjects with facial lines

Who may be able to join

Ability to assess facial lines in a mirror
Removal of facial jewelry and makeup for study visit

Who cannot join

Infection or skin disorder affecting the face
Planned use of botulinum toxin of any serotype between Screening and Day 1
Planned facial cosmetic procedure between Screening and Day 1
Planned excessive/prolonged sun exposure between Screening and Day 1

Trial locations and contacts

1 site in 1 country.

Japan1 site

Study site
Tokyo

Other trials in Japan

About this study

This study will evaluate the inter-rater and intra-rater reliability of the Facial Wrinkle Scale with Asian Photonumeric Guide (FWS-A) in Japanese subjects.

Conditions: Facial Rhytides
Being tested: No Intervention

What participants receive

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

No InterventionDrug
No intervention.

Study groups in NCT01600729
Study group	Role	What they receive
All Participants		Participants with facial lines. There was no intervention in this study. Receives: Drug: No Intervention

What is being measured

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

Inter-rater Reliability of Assessment of Facial Lines Using the 4-Point Facial Wrinkle Scale (FWS-A)
Inter-rater (among raters) agreement of the FWS-A scores (0= none; 1= mild; 2= moderate; 3= severe) was evaluated by Kappa statistics. Kappa statistics were calculated for each of 7 raters who evaluated 66 participant's severity of facial lines in 4 areas (Glabellar Lines, Forehead Lines, Crow's Feet Lines on the Left side of the face and Crow's Feet Lines on the Right side of the face) at rest and maximum expression using the FWS-A scale. The overall inter-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 predefined as: ≤ 0= poor, 0.00-0.20= slight, 0.21-0.40= fair, 0.41-0.60= moderate, 0.61-0.80= substantial and 0.81-1.00= almost perfect. The 95% confidence interval for Kappa statistics was provided.
Measured: Day 1
Intra-rater Reliability of Assessment of Facial Lines Using the 4-Point Facial Wrinkle Scale (FWS-A)
Intra-rater (within raters) agreement of the FWS-A scores (0=none; 1=mild; 2=moderate; 3=severe) was evaluated by weighted Kappa statistics (WKS). WKS were calculated for each of 7 raters who evaluated 65 participant's severity of facial lines in 4 areas (Glabellar Lines, Forehead Lines, Crow's Feet Lines on the Left side of the face and Crow's Feet Lines on the Right side of the face) at rest and maximum expression using the FWS-A scale at 2 different time-points on Day 1. The overall intra-rater agreement for WKS for all raters combined was estimated by pooling WKS for each rater using a chi-square statistic. The degree of agreement of the point estimates of WKS was interpreted according to the reference range scale that was predefined as: ≤0=poor, 0.00-0.20=slight, 0.21-0.40=fair, 0.41-0.60=moderate, 0.61-0.80=substantial and 0.81-1.00=almost perfect. The 95% confidence interval for WKS was 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.

Jun 2012Jul 2012

First posted17 May 2012 (estimated)
Study startJun 2012
Primary completionJul 2012
Study completionJul 2012

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 Facial RhytidesStudies 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: 66 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT01600729
Sponsor's protocol ID: 191622-119
Status last verified: Sep 2013
First submitted: 15 May 2012
Last updated: 30 Sep 2013
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 Facial Rhytides trials

Study at a glance

From the registry record, last updated by the sponsor on 30 Sep 2013. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Reliability of the Facial Wrinkle Scale in Japanese Subjects
ClinicalTrials.gov ID: NCT01600729
Acronym / sponsor ID: 191622-119
Conditions: Facial Rhytides
Study type: Observational
Recruitment status: Completed
Enrolment: 66 participants (actual)
Lead sponsor: AllerganIndustry (pharma, biotech, devices)
Study start: Jun 2012
Primary completion: Jul 2012 (actual)
Study completion: Jul 2012 (actual)
First posted: 17 May 2012 (estimated)
Results: Posted 17 Sep 2013

Clinical summary

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

This study will evaluate the inter-rater and intra-rater reliability of the Facial Wrinkle Scale with Asian Photonumeric Guide (FWS-A) in Japanese subjects.

Study design

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

Arm	Type	Receives
All Participants	–	Drug: No InterventionParticipants with facial lines. There was no intervention in this study.

Who may qualify

Ages: 20 to 64 years
Sex: All
Healthy volunteers: Accepted
Age groups: Adult
Study population: Subjects with facial lines

Key inclusion criteria (2 listed)

Ability to assess facial lines in a mirror
Removal of facial jewelry and makeup for study visit

Key exclusion criteria (4 listed)

Infection or skin disorder affecting the face
Planned use of botulinum toxin of any serotype between Screening and Day 1
Planned facial cosmetic procedure between Screening and Day 1
Planned excessive/prolonged sun exposure between Screening and Day 1

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 intervention.	Drug	All Participants

Primary outcome

Inter-rater Reliability of Assessment of Facial Lines Using the 4-Point Facial Wrinkle Scale (FWS-A)
Time frame: Day 1
Inter-rater (among raters) agreement of the FWS-A scores (0= none; 1= mild; 2= moderate; 3= severe) was evaluated by Kappa statistics. Kappa statistics were calculated for each of 7 raters who evaluated 66 participant's severity of facial lines in 4 areas (Glabellar Lines, Forehead Lines, Crow's Feet Lines on the Left side of the face and Crow's Feet Lines on the Right side of the face) at rest and maximum expression using the FWS-A scale. The overall inter-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 predefined as: ≤ 0= poor, 0.00-0.20= slight, 0.21-0.40= fair, 0.41-0.60= moderate, 0.61-0.80= substantial and 0.81-1.00= almost perfect. The 95% confidence interval for Kappa statistics was provided.
Intra-rater Reliability of Assessment of Facial Lines Using the 4-Point Facial Wrinkle Scale (FWS-A)
Time frame: Day 1
Intra-rater (within raters) agreement of the FWS-A scores (0=none; 1=mild; 2=moderate; 3=severe) was evaluated by weighted Kappa statistics (WKS). WKS were calculated for each of 7 raters who evaluated 65 participant's severity of facial lines in 4 areas (Glabellar Lines, Forehead Lines, Crow's Feet Lines on the Left side of the face and Crow's Feet Lines on the Right side of the face) at rest and maximum expression using the FWS-A scale at 2 different time-points on Day 1. The overall intra-rater agreement for WKS for all raters combined was estimated by pooling WKS for each rater using a chi-square statistic. The degree of agreement of the point estimates of WKS was interpreted according to the reference range scale that was predefined as: ≤0=poor, 0.00-0.20=slight, 0.21-0.40=fair, 0.41-0.60=moderate, 0.61-0.80=substantial and 0.81-1.00=almost perfect. The 95% confidence interval for WKS was provided.

Results and safety

Results posted to the registry on 17 Sep 2013, 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	66	65

Primary outcome: Inter-rater Reliability of Assessment of Facial Lines Using the 4-Point Facial Wrinkle Scale (FWS-A)

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

Measure	All Participants n = 66
Forehead Lines at Rest	0.653 (0.621 to 0.684)
Glabellar Lines at Rest	0.637 (0.607 to 0.668)
Crow's Feet Left Side at Rest	0.647 (0.616 to 0.678)
Crow's Feet Right Side at Rest	0.654 (0.623 to 0.685)
Forehead Lines at Maximum Brow Elevation	0.527 (0.495 to 0.560)
Glabellar Lines at Maximum Frown	0.507 (0.473 to 0.540)
Crow's Feet Left Side at Maximum Smile	0.641 (0.610 to 0.671)
Crow's Feet Right Side at Maximum Smile	0.622 (0.592 to 0.653)

Population analysed: Reliability population included all enrolled participants with at least 1 assessment by at least 1 live rater performed on day 1.

Primary outcome: Intra-rater Reliability of Assessment of Facial Lines Using the 4-Point Facial Wrinkle Scale (FWS-A)

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

Measure	All Participants n = 65
Forehead Lines at Rest	0.886 (0.858 to 0.914)
Glabellar Lines at Rest	0.861 (0.832 to 0.890)
Crow's Feet Left Side at Rest	0.841 (0.809 to 0.872)
Crow's Feet Right Side at Rest	0.838 (0.806 to 0.869)
Forehead Lines at Maximum Brow Elevation	0.810 (0.775 to 0.846)
Glabellar Lines at Maximum Frown	0.770 (0.731 to 0.808)
Crow's Feet Left Side at Maximum Smile	0.836 (0.804 to 0.867)
Crow's Feet Right Side at Maximum Smile	0.832 (0.800 to 0.864)

Population analysed: Participants from the Reliability population (all enrolled participants with at least 1 assessment by at least 1 live rater performed on day 1) who had 2 assessments on Day 1 available for analysis.

Adverse events

Other adverse events reported at 5% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
All Participants	0 of 66 (0%)	0 of 66 (0%)	Not reported

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 30 Sep 2013.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.

Related trials for Facial Rhytides

Active, not recruiting
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Wrinkle, Lax Skin
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Can TrenibotulinumtoxinE Reverse OnabotulinumtoxinA Effect in Treating Lateral Canthal Lines?
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Not yet recruiting
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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 Facial Rhytides, run by Allergan at 1 site in Japan.

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 30 Sep 2013. 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 Japan. 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 17 Sep 2013). 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 of Assessment of Facial Lines Using the 4-Point Facial Wrinkle Scale (FWS-A) (time frame: Day 1). The study lists 2 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 NCT01600729.

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 Sep 2013.