Wrinkled StructureNCT02543970
A Confirmatory Study for Evaluation of the Treatment by the Celluma3 of Periorbital Wrinkles
An observational study of Wrinkled Structure, run by BioPhotas.
Trial summary
The primary objective of this study is to confirm the safe and effective use of the Celluma3 for the reduction in the appearance of periorbital wrinkles. Read more about this study
- Who is it for?
- Ages 30 to 75 yearsHealthy volunteers can take part
- Conditions the study is for
- Wrinkled Structure
- How many people
- 42 participants
- Where
- No sites listed yet
- Study dates
- Feb 2015to Aug 2015
- 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 30 to 75 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: Test subjects will be between the ages of 30-75, Type I-IV Fitzpatrick Skin Color, and willingness and ability to participate and comply with the test protocol and absence of exclusionary criteria.
Who may be able to join
- 30-75 years of age
- Fitzpatrick Skin Color Type I-IV
- Clinical evidence of mild to moderate facial wrinkles as specified by the Fitzpatrick Classification of Facial Wrinkling (Perioral and Periorbital) for the degree of wrinkling and elastosis.
- Willingness and ability to comply with the protocol requirements, including returning for follow up visits and abstaining from excluded behaviors for the duration of the study.
- Willingness and ability to provide written consent for use of photographic record and adherence to photographic procedures (i.e., removal of makeup and jewelry).
- Willingness and ability to provide written informed consent prior to any study-related procedure.
- Absence of any of the exclusionary criteria
Who cannot join
- Subject who is pregnant, nursing, or planning to become pregnant during the course of the study.
- Subjects who have any history of diabetes.
- Subjects who, in the preceding 12 months prior to the study start, have:
- Been exposed to hyaluronic acid, or
- any other filler, or
- injection for cosmetic purposes related to the face, or
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- undergone any cosmetic procedure for the face, or
- had an active cut, wound or infection of the face, or
- had oral isotretinon.
- Subjects who, in the preceding six months prior to the study start, have:
- Had any botulinum toxin ("Botox"), or
- had ablative skin resurfacing on the glabellar area.
- Subjects who, in the preceding three months prior to the study start, have:
- Had retinoid, microdermabrasion or prescription level glycolic acid treatments, or
- had any compromising procedure in the opinion of any clinical evaluator.
- Any other diagnosis of any contraindication in the current User Manual.
About this study
The primary objective of this study is to confirm the safe and effective use of the Celluma3 for the reduction in the appearance of periorbital wrinkles.
Read the detailed description
This clinical study is an open label investigation into the use of the Celluma3 for the effective treatment of periorbital wrinkles.
Test subjects will visit a study center for thirty minute treatments, three times per week, for a period of four weeks, and a twelve week post-treatment follow up after the final treatment. Test subjects will have photos taken at the start, at the end of the four week treatment, and at the final twelve week post-treatment follow up visit.
One of the three Clinical Investigators, will act as the Principal Investigator and all three Clinical Investigators will evaluate the test subjects for inclusion and final results. The Clinical Research Associate (CRA) will monitor the study for conformance to the test protocol.
There will be seven estheticians participating in the study and there will be fifty test subjects recruited.
- Conditions
- Wrinkled Structure
What is being measured
The primary outcome is the main question the study is designed to answer.
Reduction of Periorbital Wrinkles
4 weeks of treatment and 12 week follow-up post treatment
Measured: 16 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Sep 2015 (estimated)
- Study startFeb 2015
- Primary completionAug 2015
- Study completionAug 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Wrinkled StructureStudies 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
- Case only
- Time perspective
- Prospective
- Enrolment
- 42 participants (actual)
Sponsor and investigators
- Lead sponsor
- BioPhotas
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Jesse Mitchell, MD, FAAD, Principal investigator
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02543970
- Sponsor's protocol ID
- RLE-001
- Status last verified
- Sep 2015
- First submitted
- 4 Sep 2015
- Last updated
- 9 Sep 2015
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 9 Sep 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Confirmatory Study for Evaluation of the Treatment by the Celluma3 of Periorbital Wrinkles
- ClinicalTrials.gov ID
- NCT02543970
- Acronym / sponsor ID
- RLE-001
- Conditions
- Wrinkled Structure
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 42 participants (actual)
- Lead sponsor
- BioPhotasIndustry (pharma, biotech, devices)
- Study start
- Feb 2015
- Primary completion
- Aug 2015 (actual)
- Study completion
- Aug 2015 (actual)
- First posted
- 9 Sep 2015 (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 confirm the safe and effective use of the Celluma3 for the reduction in the appearance of periorbital wrinkles.
Detailed description
This clinical study is an open label investigation into the use of the Celluma3 for the effective treatment of periorbital wrinkles.
Test subjects will visit a study center for thirty minute treatments, three times per week, for a period of four weeks, and a twelve week post-treatment follow up after the final treatment. Test subjects will have photos taken at the start, at the end of the four week treatment, and at the final twelve week post-treatment follow up visit.
One of the three Clinical Investigators, will act as the Principal Investigator and all three Clinical Investigators will evaluate the test subjects for inclusion and final results. The Clinical Research Associate (CRA) will monitor the study for conformance to the test protocol.
There will be seven estheticians participating in the study and there will be fifty test subjects recruited.
Study design
- Observational model
- Case only
- Time perspective
- Prospective
Who may qualify
- Ages
- 30 to 75 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Test subjects will be between the ages of 30-75, Type I-IV Fitzpatrick Skin Color, and willingness and ability to participate and comply with the test protocol and absence of exclusionary criteria.
Key inclusion criteria (7 listed)
- 30-75 years of age
- Fitzpatrick Skin Color Type I-IV
- Clinical evidence of mild to moderate facial wrinkles as specified by the Fitzpatrick Classification of Facial Wrinkling (Perioral and Periorbital) for the degree of wrinkling and elastosis.
- Willingness and ability to comply with the protocol requirements, including returning for follow up visits and abstaining from excluded behaviors for the duration of the study.
- Willingness and ability to provide written consent for use of photographic record and adherence to photographic procedures (i.e., removal of makeup and jewelry).
Key exclusion criteria (16 listed)
- Subject who is pregnant, nursing, or planning to become pregnant during the course of the study.
- Subjects who have any history of diabetes.
- Subjects who, in the preceding 12 months prior to the study start, have:
- Subjects who, in the preceding six months prior to the study start, have:
- Subjects who, in the preceding three months prior to the study start, have:
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Reduction of Periorbital Wrinkles
Time frame: 16 weeks
4 weeks of treatment and 12 week follow-up post treatment
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Sep 2015.
Related trials for Wrinkled Structure
Recruiting
Effect of Single Facial Acupuncture on Dermal Structure and Appearance Satisfaction
Facial Aging, Wrinkles
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.
Jesse Mitchell, MD, FAAD principal investigator
Questions about this trial
What is this clinical trial studying?
An observational study of Wrinkled Structure, run by BioPhotas.
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 7 inclusion and 16 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 9 Sep 2015. 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.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Reduction of Periorbital Wrinkles (time frame: 16 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 9 Sep 2015.