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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.
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.
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| Measure | Description | Time Frame |
|---|---|---|
| Reduction of Periorbital Wrinkles | 4 weeks of treatment and 12 week follow-up post treatment | 16 weeks |
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Inclusion Criteria:
Exclusion Criteria:
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:
Any other diagnosis of any contraindication in the current User Manual.
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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.
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| Name | Affiliation | Role |
|---|---|---|
| Jesse Mitchell, MD, FAAD | Principal Investigator |
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