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History of Changes for Study: NCT01689012
The Effect of Facial Exercise on the Appearance of Aging
Latest version (submitted December 2, 2021) on ClinicalTrials.gov
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Study Record Versions
Version A B Submitted Date Changes
1 September 14, 2012 None (earliest Version on record)
2 September 27, 2012 Recruitment Status, Study Status and Contacts/Locations
3 February 7, 2013 Recruitment Status, Study Status and Contacts/Locations
4 February 20, 2014 Study Status
5 March 2, 2015 Recruitment Status, Study Status and Study Design
6 December 2, 2021 Study Status
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Study NCT01689012
Submitted Date:  September 14, 2012 (v1)

Open or close this module Study Identification
Unique Protocol ID: STU68255
Brief Title: The Effect of Facial Exercise on the Appearance of Aging
Official Title: A Pilot Study of the Efficacy of a Facial Exercise Program
Secondary IDs:
Open or close this module Study Status
Record Verification: September 2012
Overall Status: Not yet recruiting
Study Start: January 2013
Primary Completion: September 2013 [Anticipated]
Study Completion: September 2014 [Anticipated]
First Submitted: September 14, 2012
First Submitted that
Met QC Criteria:
September 14, 2012
First Posted: September 20, 2012 [Estimate]
Last Update Submitted that
Met QC Criteria:
September 14, 2012
Last Update Posted: September 20, 2012 [Estimate]
Open or close this module Sponsor/Collaborators
Sponsor: Northwestern University
Responsible Party: Principal Investigator
Investigator: Murad Alam
Official Title: Professor in Dermatology, Otolaryngology- Head and Neck Surgery, and Surgery-Organ Transplantation
Affiliation: Northwestern University
Collaborators:
Open or close this module Oversight
U.S. FDA-regulated Drug:
U.S. FDA-regulated Device:
Data Monitoring: No
Open or close this module Study Description
Brief Summary: This study seeks to evaluate the effects of facial exercises on aging of the face.
Detailed Description:
Open or close this module Conditions
Conditions: Aging
Keywords:
Open or close this module Study Design
Study Type: Interventional
Primary Purpose: Prevention
Study Phase: Not Applicable
Interventional Study Model: Single Group Assignment
Number of Arms: 1
Masking: Single (Outcomes Assessor)
Allocation: N/A
Enrollment: 50 [Anticipated]
Open or close this module Arms and Interventions
Arms Assigned Interventions
Experimental: Facial Exercise Behavioral: Facial Exercise
Open or close this module Outcome Measures
Primary Outcome Measures:
1. Improvement of face and neck after facial exercise compared to baseline
[ Time Frame: up to 20 weeks ]

Open or close this module Eligibility
Minimum Age: 40 Years
Maximum Age: 65 Years
Sex: All
Gender Based:
Accepts Healthy Volunteers: Yes
Criteria:

Inclusion Criteria:

  • Aged 40-65 years
  • No significant medical illness
  • No chronic smokers
  • Subject with mild to moderate facial atrophy
  • Subjects who provide and interest and who understand the importance of consistently executing the program daily.
  • Subjects with the willingness and ability to understand and provide informed consent.

Exclusion Criteria:

  • Under 40 years of age, Over 65 years of age
  • Pregnant or lactating
  • Subjects who have ever had any invasive cosmetic procedure, including facelifts, neck lifts, laser resurfacing, dermabrasion, or liposuction
  • Subjects who have non-invasive or minimally invasive cosmetic procedures, such a non-ablative lasers, medium-depth or deeper chemical peels, injectable neurotoxins or fillers, within the past year.
  • Subjects who have used topical or oral retinoids within the past year.
Open or close this module Contacts/Locations
Central Contact Person: Emily Poon, PhD
Telephone: 312-695-4761
Email: research.nuderm@northwestern.edu
Study Officials: Murad Alam, MD
Principal Investigator
Northwestern University
Locations: United States, Illinois
Northwestern University Feinberg School of Medicine, Department of Dermatology
Chicago, Illinois, United States, 60611
Contact:Contact: Emily Poon, PhD research.nuderm@northwestern.edu
Contact:Principal Investigator: Murad Alam, MD
Open or close this module IPDSharing
Plan to Share IPD:
Open or close this module References
Citations:
Links:
Available IPD/Information:

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