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Reliability of the Facial Wrinkle Scale in Japanese Subjects

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Allergan
ClinicalTrials.gov Identifier:
NCT01600729
First received: May 15, 2012
Last updated: July 10, 2012
Last verified: July 2012
History of Changes
  Purpose

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.


Condition
Facial Rhytides

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective

Further study details as provided by Allergan:

Primary Outcome Measures:
  • Inter-rater Reliability of Assessment of Facial Lines Using the 4-Point FWS-A [ Time Frame: Day 1 ] [ Designated as safety issue: No ]
  • Intra-rater Reliability of Assessment of Facial Lines Using the 4-Point FWS-A [ Time Frame: Day 1 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Independent Photographic Raters' Assessment of Facial Lines Using the 4-Point FWS-A [ Time Frame: Day 1 ] [ Designated as safety issue: No ]

Enrollment: 66
Study Start Date: June 2012
Study Completion Date: July 2012
Primary Completion Date: July 2012 (Final data collection date for primary outcome measure)
Groups/Cohorts
Subjects with Facial Lines
Subjects with Facial Lines

  Eligibility

Ages Eligible for Study:   20 Years to 64 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population

Subjects with facial lines

Criteria

Inclusion Criteria:

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

Exclusion Criteria:

  • 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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01600729

Locations
Japan
Tokyo, Japan
Sponsors and Collaborators
Allergan
Investigators
Study Director: Medical Director Allergan
  More Information

No publications provided

Responsible Party: Allergan
ClinicalTrials.gov Identifier: NCT01600729     History of Changes
Other Study ID Numbers: 191622-119
Study First Received: May 15, 2012
Last Updated: July 10, 2012
Health Authority: Japan: Pharmaceuticals and Medical Devices Agency

Additional relevant MeSH terms:
Facies
Disease Attributes
Pathologic Processes

ClinicalTrials.gov processed this record on May 23, 2013