Loss of Facial Adipose TissueFACENCT03347747
Facial Asymmetrical Clinical Evaluation Study
An observational study of Loss of Facial Adipose Tissue, run by McDaniel Institute of Anti-Aging Research at 1 site in United States.
Trial summary
The primary objective of this study is to create digital 3D images of subjects using a Canfield VECTRA H1 digital imaging system and compile a medical, skin/sun exposure and sunscreen use, and skin care product history for a large number of subjects. Read more about this study
- Who is it for?
- Ages 45 to 80 yearsHealthy volunteers can take part
- Conditions the study is for
- Loss of Facial Adipose Tissue
- What is being tested?
- Study Photography + Personal & Medical History Collection
- How many people
- 400 participants
- Where
- 1 siteUnited States
- Study dates
- 9 Jun 2017to 31 Jul 2018
- Phase
- Observational
- Are there results?
- None posted in the registry
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 45 to 80 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: the study will consist of up to 500 volunteer 45-80 year old males or females with visible photoaging and the desired exposure profile/driving history. If a subject meets study criteria and is enrolled, they will have 3D facial images taken and complete a detailed study questionnaire
Who may be able to join
- Subjects must be 45 to 80 years of age with no known medical conditions that, in the investigator's opinion, may interfere with study participation.
- 2. Subjects must have spent, at minimum, an average of at least 30 minutes per day/ 5 days per week (as the driver) in an automobile for greater than or equal to 15 years of their adult life.
- 3. Subjects must sign a written informed consent. 4. Subjects must agree to be photographed with the 3D camera system and sign a photo release.
- 5. Subjects must agree to fill out the study questionnaire completely and to the best of their knowledge.
- 6. Subjects must agree that the de-identified data and 3D images may be used for data mining to answer future study questions or assist in new investigations and discoveries.
Who cannot join
- Any dermatologic disorder, which in the investigator's opinion, may interfere with the accurate evaluation of the subject's facial skin. Examples of such disorders include severe acne vulgaris, acne conglobata, acne fulminans, facial seborrheic dermatitis, and lupus erythematosus.
- 2. Concurrent therapy with any medication either topical or oral that might, in the investigator's opinion, interfere with the study.
- 3. Subjects who have had performed procedures which, in the study doctor's opinion, may interfere with the study data (for example: face lift, facial liposuction or facial volume fillers in the last 2 years) 4. Subjects whose primary automobile (used in the average drive estimate) has dark tinted window glass or UV filter applied to the driver's side window glass.
- 5. Subjects who have spent a large portion of their lives at two very different latitude/locations (eg. Alternate 6 months of the year at a summer home in Maine and a winter home in Florida).
- 6. Subjects who are unwilling or unable to comply with the requirements of the protocol.
- 7. Subject has any disorder that may prevent compliance, such as history of chronic alcohol or drug abuse, significant mental or nervous disorder or other illness that would, in the evaluator's opinion, interfere with the study.
- 8. Subjects with visible (or excessive vellus) facial hair (facial hair interferes with the 3D imaging capture and analysis).
- 9. Subject's weight has ever been more than 30 lbs above or below current weight (does not include weight gain associated with pregnancy)
Trial locations and contacts
1 site in 1 country.
United States1 site, 1 recruiting
- Recruiting
McDaniel Institute of Anti-Aging Research
Virginia Beach, Virginia, 23462
Charmaine L Griffin, 757-417-8300, cgriffin@drmcdaniel.com
Chris Mazur, 757-417-8300, cmazur@drmcdaniel.com
About this study
Official title: Asymmetrical Facial Volume Loss From Disproportionate Light Exposure: A Clinical Validation Study
The primary objective of this study is to create digital 3D images of subjects using a Canfield VECTRA H1 digital imaging system and compile a medical, skin/sun exposure and sunscreen use, and skin care product history for a large number of subjects. This data will allow for image and statistical analysis to determine if facial volume loss is greater on one side, and what factors may be causing this.
The data collected will also serve as a database for future lines of inquiry relating to data collected in this study. Your data (including 3D images) will be kept in this database and may be accessed in the future by any Sponsor or Investigator. Your data will be de-identified and your name will not be associated with the questionnaire responses
Read the detailed description
It has been long noted that facial volume loss is one of the primary visible components of aging. Asymmetrical volume loss has been noted as well, but there is no proven theory explaining why this occurs.
This study will attempt to determine whether there is an association between greater facial volume loss on the drivers' window side of the face.
This data will allow for image and statistical analysis to determine if a facial volume loss differential exists, and what factors may be isolated to determine causality The study population will be between 350-500 males or females aged 45-80 having visible photodamage and spent (or are spending) at least 30 minutes in a car per day (as the driver), 5 days per week for at least 15 years of their adult life to ensure they have the type of asymmetrical exposure required for hypothesis validation.
This will be a multi-center trial, and study sites will range from northern to southern latitudes in North America, Australia and potentially other international sites.
This study is to be conducted under the general supervision of PI(s) and will follow the general guidelines recommended in current Good Clinical Practices (cGCP).
Individual sites will have a PI to supervise study related procedures and data collection and will be in contact with Dr. McDaniel and staff throughout the study.
The study period for each subject will be approximately 1-2 visits. Consented and qualified subjects will be imaged using the Canfield VECTRA H1 digital imaging system as described above and then given the study questionnaire and completion instructions. Once the subject has had both the images and questionnaire reviewed by study personnel for completeness, their participation in this study is ended; unless the supplemental contact visit is determined to be required for data clarification or additional, IRB approved, follow up questions.
- Conditions
- Loss of Facial Adipose Tissue
- Being tested
- Study Photography + Personal & Medical History Collection
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Study Photography + Personal & Medical History CollectionOther
3D facial images taken and complete a detailed study questionnaire
| Study group | Role | What they receive |
|---|---|---|
| Photoaged Male Subjects | 45-80 year old males with visible photoaging and the desired exposure profile/driving history and who also has spent (or are spending) at least 30 minutes in a car per day (as the driver), 5 days per week for at least 15 years of their adult life to ensure they have the type of asymmetrical exposure required for hypothesis validation. This is an multi-center trial, and study sites will range from northern to southern latitudes in North America, Australia and potentially other international sites. Study Photography + Personal \& Medical History Collection via a study questionnaire will be obtained. Receives: Other: Study Photography + Personal & Medical History Collection | |
| Photoaged Female Subjects | 45-80 year old females with visible photoaging and the desired exposure profile/driving history and who also has spent (or are spending) at least 30 minutes in a car per day (as the driver), 5 days per week for at least 15 years of their adult life to ensure they have the type of asymmetrical exposure required for hypothesis validation. This is an multi-center trial, and study sites will range from northern to southern latitudes in North America, Australia and potentially other international sites. Study Photography + Personal \& Medical History Collection via a study questionnaire will be obtained. Receives: Other: Study Photography + Personal & Medical History Collection |
What is being measured
The primary outcome is the main question the study is designed to answer.
Study Photos and Questionnaire Data Processing
The questionnaire data will be entered into a central spreadsheet for future analysis. The images will be uploaded directly to Canfield Scientific for image review and analyzed using software based on a "best fit" algorithm designed using 1000 facial images to determine any volume differences between the right and left sides of the face. Statistical significance will be generated for the data and applied to the general population of 300,000,000 with a 95% confidence interval (based on a study population of 400 subjects). Detailed statistics may be performed utilized using an online statistics calculator as required. The full complement of images and data from each site, will be returned to the McDaniel Institute of Anti-Aging Research.
Measured: June 2018
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Nov 2017
- Study start9 Jun 2017
- Primary completion30 Jun 2018 (estimated)
- Study completion31 Jul 2018 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Loss of Facial Adipose TissueStudies 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
- 400 participants (estimated)
Sponsor and investigators
- Lead sponsor
- McDaniel Institute of Anti-Aging Research
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Allergan, Merz Aesthetics Inc., ThermiGen, LLC
- Responsible party
- Sponsor
- Investigators
- Daivd H. McDaniel, MD, Study director, MIAAR
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03347747
- Sponsor's protocol ID
- FCLVOL-2017
- Acronym
- FACE
- Status last verified
- Nov 2017
- First submitted
- 5 Nov 2017
- Last updated
- 20 Nov 2017
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 20 Nov 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Asymmetrical Facial Volume Loss From Disproportionate Light Exposure: A Clinical Validation Study
- ClinicalTrials.gov ID
- NCT03347747
- Acronym / sponsor ID
- FACE / FCLVOL-2017
- Conditions
- Loss of Facial Adipose Tissue
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 400 participants (estimated)
- Lead sponsor
- McDaniel Institute of Anti-Aging ResearchIndustry (pharma, biotech, devices)
- Collaborators
- Allergan, Merz Aesthetics Inc., ThermiGen, LLC
- Study start
- 9 Jun 2017 (actual)
- Primary completion
- 30 Jun 2018 (estimated)
- Study completion
- 31 Jul 2018 (estimated)
- First posted
- 20 Nov 2017 (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.
The primary objective of this study is to create digital 3D images of subjects using a Canfield VECTRA H1 digital imaging system and compile a medical, skin/sun exposure and sunscreen use, and skin care product history for a large number of subjects. This data will allow for image and statistical analysis to determine if facial volume loss is greater on one side, and what factors may be causing this.
The data collected will also serve as a database for future lines of inquiry relating to data collected in this study. Your data (including 3D images) will be kept in this database and may be accessed in the future by any Sponsor or Investigator. Your data will be de-identified and your name will not be associated with the questionnaire responses
Detailed description
It has been long noted that facial volume loss is one of the primary visible components of aging. Asymmetrical volume loss has been noted as well, but there is no proven theory explaining why this occurs.
This study will attempt to determine whether there is an association between greater facial volume loss on the drivers' window side of the face.
This data will allow for image and statistical analysis to determine if a facial volume loss differential exists, and what factors may be isolated to determine causality The study population will be between 350-500 males or females aged 45-80 having visible photodamage and spent (or are spending) at least 30 minutes in a car per day (as the driver), 5 days per week for at least 15 years of their adult life to ensure they have the type of asymmetrical exposure required for hypothesis validation.
This will be a multi-center trial, and study sites will range from northern to southern latitudes in North America, Australia and potentially other international sites.
This study is to be conducted under the general supervision of PI(s) and will follow the general guidelines recommended in current Good Clinical Practices (cGCP).
Individual sites will have a PI to supervise study related procedures and data collection and will be in contact with Dr. McDaniel and staff throughout the study.
The study period for each subject will be approximately 1-2 visits. Consented and qualified subjects will be imaged using the Canfield VECTRA H1 digital imaging system as described above and then given the study questionnaire and completion instructions. Once the subject has had both the images and questionnaire reviewed by study personnel for completeness, their participation in this study is ended; unless the supplemental contact visit is determined to be required for data clarification or additional, IRB approved, follow up questions.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Photoaged Male Subjects | – | Other: Study Photography + Personal & Medical History Collection45-80 year old males with visible photoaging and the desired exposure profile/driving history and who also has spent (or are spending) at least 30 minutes in a car per day (as the driver), 5 days per week for at least 15 years of their adult life to ensure they have the type of asymmetrical exposure required for hypothesis validation. This is an multi-center trial, and study sites will range from northern to southern latitudes in North America, Australia and potentially other international sites. Study Photography + Personal \& Medical History Collection via a study questionnaire will be obtained. |
| Photoaged Female Subjects | – | Other: Study Photography + Personal & Medical History Collection45-80 year old females with visible photoaging and the desired exposure profile/driving history and who also has spent (or are spending) at least 30 minutes in a car per day (as the driver), 5 days per week for at least 15 years of their adult life to ensure they have the type of asymmetrical exposure required for hypothesis validation. This is an multi-center trial, and study sites will range from northern to southern latitudes in North America, Australia and potentially other international sites. Study Photography + Personal \& Medical History Collection via a study questionnaire will be obtained. |
Who may qualify
- Ages
- 45 to 80 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- the study will consist of up to 500 volunteer 45-80 year old males or females with visible photoaging and the desired exposure profile/driving history. If a subject meets study criteria and is enrolled, they will have 3D facial images taken and complete a detailed study questionnaire
Key inclusion criteria (5 listed)
- Subjects must be 45 to 80 years of age with no known medical conditions that, in the investigator's opinion, may interfere with study participation.
- 2. Subjects must have spent, at minimum, an average of at least 30 minutes per day/ 5 days per week (as the driver) in an automobile for greater than or equal to 15 years of their adult life.
- 3. Subjects must sign a written informed consent. 4. Subjects must agree to be photographed with the 3D camera system and sign a photo release.
- 5. Subjects must agree to fill out the study questionnaire completely and to the best of their knowledge.
- 6. Subjects must agree that the de-identified data and 3D images may be used for data mining to answer future study questions or assist in new investigations and discoveries.
Key exclusion criteria (8 listed)
- Any dermatologic disorder, which in the investigator's opinion, may interfere with the accurate evaluation of the subject's facial skin. Examples of such disorders include severe acne vulgaris, acne conglobata, acne fulminans, facial seborrheic dermatitis, and lupus erythematosus.
- 2. Concurrent therapy with any medication either topical or oral that might, in the investigator's opinion, interfere with the study.
- 3. Subjects who have had performed procedures which, in the study doctor's opinion, may interfere with the study data (for example: face lift, facial liposuction or facial volume fillers in the last 2 years) 4. Subjects whose primary automobile (used in the average drive estimate) has dark tinted window glass or UV filter applied to the driver's side window glass.
- 5. Subjects who have spent a large portion of their lives at two very different latitude/locations (eg. Alternate 6 months of the year at a summer home in Maine and a winter home in Florida).
- 6. Subjects who are unwilling or unable to comply with the requirements of the protocol.
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 |
|---|---|---|
| Study Photography + Personal & Medical History Collection3D facial images taken and complete a detailed study questionnaire | Other | Photoaged Female Subjects, Photoaged Male Subjects |
Primary outcome
Study Photos and Questionnaire Data Processing
Time frame: June 2018
The questionnaire data will be entered into a central spreadsheet for future analysis. The images will be uploaded directly to Canfield Scientific for image review and analyzed using software based on a "best fit" algorithm designed using 1000 facial images to determine any volume differences between the right and left sides of the face. Statistical significance will be generated for the data and applied to the general population of 300,000,000 with a 95% confidence interval (based on a study population of 400 subjects). Detailed statistics may be performed utilized using an online statistics calculator as required. The full complement of images and data from each site, will be returned to the McDaniel Institute of Anti-Aging Research.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Nov 2017.
- Individual participant dataSharing planned: Undecided
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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.
Daivd H. McDaniel, MD study director
MIAAR
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 Loss of Facial Adipose Tissue, run by McDaniel Institute of Anti-Aging Research 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 5 inclusion and 8 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: status not confirmed, as of the sponsor's last update on 20 Nov 2017. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Charmaine L Griffin (757-417-8300, cgriffin@drmcdaniel.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Study Photos and Questionnaire Data Processing (time frame: June 2018). 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 20 Nov 2017.