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The primary objective is to assess the efficacy, safety and satisfaction associated with the resurfacing treatment of perioral lines and wrinkles with the 2,910 nm mid-infrared Fiber Laser (UltraClear, Acclaro Medical) using both superficial epidermis ablation capabilities and the deep ablative and coagulative capabilities into the dermis for rejuvenation.
Participants will receive up to two treatments spaced 6-8 weeks apart, followed by a 1-month and 3-month follow-up visit during which the device will be evaluated for its effectiveness defined as improvement addressing perioral lines and wrinkles utilizing multiple scales completed by the investigator and blinded Independent Photographic Reviewers (IPRs). Additionally, safety, subjective overall aesthetic improvement and satisfaction will be monitored and tracked.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Part 2 Clinical Study Procedure | Experimental | UltraClear 2,910nm mid-infrared laser using both superficial epidermal ablation and deep ablative and coagulative capabilities in the dermis for rejuvenation addressing perioral lines and wrinkles. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Laser Resurfacing | Device | Enrolled participants will be treated with the UltraClear 2,910nm mid-infrared laser using both superficial epidermal ablation and deep ablative and coagulative capabilities in the dermis for rejuvenation with a specific focus on perioral lines and wrinkles. |
| Measure | Description | Time Frame |
|---|---|---|
| Change in Fitzpatrick Wrinkling and Degree of Elastosis Scale (FWS) | Changes in perioral lines and wrinkles utilizing the Fitzpatrick Wrinkling and Degree of Elastosis Scale (FWS). A change of one point is considered a statistically significant change on a scale of 1-9, with one being the least noticeable wrinkles and nine being the deepest and most noticeable wrinkles. 1 - 3 Fine wrinkles 4 - 6 Fine to moderate depth wrinkles, moderate number of lines 7 - 9 Fine to deep wrinkles, numerous lines, with or without redundant skin folds | From enrollment to the final follow-up visit (3-months following final treatment) |
| Percentage of Treatment Responders | o Comparison of the proportion of subjects (i.e., percentage of treatment responders) correctly identified by at least two out of three blinded Independent Photographic Reviewers (IPR). | From enrollment to the final follow-up visit (3-months following final treatment) |
| Change in Physician Global Aesthetic Improvement Scale (PGAIS) | Defined as a change in perioral lines and wrinkles utilizing the Physician Global Aesthetic Improvement Scale (PGAIS). The PGAIS is a five-point scale used by physicians to objectively rate the aesthetic outcome of a treatment by comparing a patient's pre-treatment and post-treatment appearance. The scoring is numerical (1-5), with a score of 3, 4, or 5 points being considered significant.
| From enrollment to the final follow-up visit (3-months following final treatment) |
| Measure | Description | Time Frame |
|---|---|---|
| Subject Self-Reported Improvements | The SGAIS is a measure of aesthetic improvement relative to baseline, pre-treatment condition. A meaningful change on the Subject Global Aesthetic Improvement Scale (SGAIS) is defined as an improvement of at least one grade, indicating that the subject perceives a beneficial change in their appearance. The SGAIS is a patient-reported outcome measure (PROM) that is completed by the patient/subject to assess their own perception of aesthetic improvement following treatment. The scale is reported with scores of 1-5.
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Mary Dick, MD | Contact | 713-900-3900 | drdick@dermlasersurgery.com | |
| Leah Dickerson | Contact | leah@dermlasersurgery.com |
| Name | Affiliation | Role |
|---|---|---|
| Paul Friedman, MD | Director, Dermatology & Laser Surgery Center Clinical Assistant Professor of Dermatology, UT Medical School | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Dermatology & Laser Surgery Center | Recruiting | Houston | Texas | 77030 | United States |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| SAP | No | Yes | No | Statistical Analysis Plan | Feb 17, 2025 | Sep 9, 2025 | SAP_000.pdf |
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| From enrollment to the final follow-up visit (3-months following final treatment) |