Facial Atrophy Related to AgeEarly Phase 1NCT00952549
Facial Yoga Toning Program - A Pilot Study
A Early Phase 1 study testing Facial Yoga Toning Program in people with Facial Atrophy Related to Age, run by The Cleveland Clinic.
Trial summary
The primary objective of this study is to determine the efficacy of a facial yoga exercise program on appearance and to measure patient satisfaction with facial yoga practice. Read more about this study
- Who is it for?
- Ages 18 to 99 yearsHealthy volunteers can take part
- Conditions the study is for
- Facial Atrophy Related to Age
- What is being tested?
- Facial Yoga Toning Program
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- No sites listed yet
- Study dates
- Aug 2009to Sep 2009
- Phase
- Early Phase 1
- 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 18 to 99 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- over age 18 years
Who cannot join
- pregnancy
About this study
The primary objective of this study is to determine the efficacy of a facial yoga exercise program on appearance and to measure patient satisfaction with facial yoga practice.
Read the detailed description
This is a single center prospective longitudinal pilot study of 27 subjects. The study will include 20 study subjects and 7 controls. Participants in this study will be healthy subjects 18 years and older with mild to moderate facial atrophy without a history of surgical or non-surgical treatment to the area. The study subjects will perform facial yoga and apply sunscreen (Neutrogena Helioplex SPF 55) daily. The controls will apply sunscreen alone daily for 8 weeks.
- Conditions
- Facial Atrophy Related to Age
- Being tested
- Facial Yoga Toning Program
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Facial Yoga Toning ProgramProcedure or surgery
Patients will be instructed on 18 exercises which are intended to strengthen and tone the muscles of facial expression. DVD is provided.
| Study group | Role | What they receive |
|---|---|---|
| Facial Yoga Toning Program | Experimental | Patients will be instructed on 18 exercises which are intended to strengthen and tone the muscles of facial expression. DVD is provided. Receives: Procedure: Facial Yoga Toning Program |
What is being measured
The primary outcome is the main question the study is designed to answer.
Efficacy of facial yoga toning program on aesthetic appearance
subjects will be photographed and investigator will complete Global Aesthetic Improvement Scale to document results at baseline, 2, 4, 6, and 8 weeks
Measured: 8 weeks
Secondary outcomes (1)
subject satisfaction with facial yoga toning program
subjects will complete satisfaction survey at baseline, 2, 4, 6, and 8 weeks
Measured: 8 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Aug 2009 (estimated)
- Study startAug 2009
- Primary completionAug 2009
- Study completionSep 2009
Why it stopped: Investigator no longer at Cleveland Clinic
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Facial Atrophy Related to AgeStudies of the same condition, open and under way.
- More trials run by The Cleveland ClinicThe sponsor's other registered studies.
- 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
- Interventional
- Phase
- Early Phase 1
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- The Cleveland Clinic
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Rebecca Tung, MD, Principal investigator, The Cleveland ClinicWilma Bergfeld, MD, Principal investigator, The Cleveland Clinic
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00952549
- Sponsor's protocol ID
- FYTP
- Status last verified
- Jan 2018
- First submitted
- 4 Aug 2009
- Last updated
- 26 Jan 2018
- Results posted
- No
- Data monitoring committee
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 26 Jan 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Facial Yoga Toning Program - A Pilot Study
- ClinicalTrials.gov ID
- NCT00952549
- Acronym / sponsor ID
- FYTP
- Conditions
- Facial Atrophy Related to Age
- Phase
- Early Phase 1
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: Investigator no longer at Cleveland Clinic
- Enrolment
- 0 participants (actual)
- Lead sponsor
- The Cleveland ClinicUniversity, hospital or other
- Study start
- Aug 2009
- Primary completion
- Aug 2009 (actual)
- Study completion
- Sep 2009 (actual)
- First posted
- 6 Aug 2009 (estimated)
- 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 determine the efficacy of a facial yoga exercise program on appearance and to measure patient satisfaction with facial yoga practice.
Detailed description
This is a single center prospective longitudinal pilot study of 27 subjects. The study will include 20 study subjects and 7 controls. Participants in this study will be healthy subjects 18 years and older with mild to moderate facial atrophy without a history of surgical or non-surgical treatment to the area. The study subjects will perform facial yoga and apply sunscreen (Neutrogena Helioplex SPF 55) daily. The controls will apply sunscreen alone daily for 8 weeks.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Facial Yoga Toning Program | Experimental | Procedure: Facial Yoga Toning ProgramPatients will be instructed on 18 exercises which are intended to strengthen and tone the muscles of facial expression. DVD is provided. |
Who may qualify
- Ages
- 18 to 99 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- over age 18 years
Key exclusion criteria (1 listed)
- pregnancy
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 |
|---|---|---|
| Facial Yoga Toning ProgramPatients will be instructed on 18 exercises which are intended to strengthen and tone the muscles of facial expression. DVD is provided. | Procedure or surgery | Facial Yoga Toning Program |
Primary outcome
Efficacy of facial yoga toning program on aesthetic appearance
Time frame: 8 weeks
subjects will be photographed and investigator will complete Global Aesthetic Improvement Scale to document results at baseline, 2, 4, 6, and 8 weeks
1 secondary outcome
subject satisfaction with facial yoga toning program
Time frame: 8 weeks
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Jan 2018.
- Individual participant dataSharing planned: No
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.
Rebecca Tung, MD principal investigator
The Cleveland Clinic
Wilma Bergfeld, MD principal investigator
The Cleveland Clinic
Questions about this trial
What is this clinical trial studying?
A Early Phase 1 study testing Facial Yoga Toning Program in people with Facial Atrophy Related to Age, run by The Cleveland Clinic.
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 1 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: withdrawn, as of the sponsor's last update on 26 Jan 2018. Status can change between updates, so confirm with the study contact before making plans.
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.
What does this phase mean?
Early Phase 1 (sometimes called Phase 0) studies give a very small amount of a treatment to a few people, mainly to see how the body handles it.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study was withdrawn before enrolling participants, so there are no results.
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?
Efficacy of facial yoga toning program on aesthetic appearance (time frame: 8 weeks). 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 26 Jan 2018.