Laser Treatment for Advanced Perioral Lines and Wrinkles
This study is testing a laser called the UltraClear 2,910nm mid-infrared laser to see how well it treats advanced lines and wrinkles around the mouth (perioral lines and wrinkles). The laser works by gently removing the top layer of skin and also heating deeper layers to help rejuvenate the skin. Researchers want to know if this treatment is effective, safe, and if people are happy with the results. You might be able to join if you are between 50 and 80 years old and have certain skin types (Fitzpatrick skin type I-IV). The study will measure success by looking at changes in wrinkle scales and how many people show improvement. The current status of this study is unclear.
- Study design
- This interventional study plans to enroll 20 participants. It will assess the effects of the UltraClear 2,910nm mid-infrared laser on perioral lines and wrinkles.
- What's involved
- You would receive up to two laser treatments, spaced 6-8 weeks apart. There will be follow-up visits at 1 month and 3 months after your final treatment.
- Compensation
- Not stated in the trial record.
- Follow-up
- Participants will be followed for 3 months after their final treatment to assess the results.
AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.
2910 nm Erbium-Doped Fluoride Fiber Glass Laser for the Treatment of Advanced Perioral Lines and Wrinkles
At a glance
Conditions
NCT07222397
Where you'd take part
This study runs at 1 site. They're the same protocol — you choose where, and that choice sets who your contact draft is addressed to.
Dermatology & Laser Surgery Center
Houston, Texasno site contact published
Recruiting
Sites open and close at different times, so the status above is per site — it can differ from the study's overall status.
Study leadership
- Paul Friedman, MD · PRINCIPAL_INVESTIGATOR · Director, Dermatology & Laser Surgery Center Clinical Assistant Professor of Dermatology, UT Medical School
Who to contact
Opens a ready-to-send draft in your own email app — review before sending.
What this trial measures
- Change in Fitzpatrick Wrinkling and Degree of Elastosis Scale (FWS)From enrollment to the final follow-up visit (3-months following final treatment)
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
- Percentage of Treatment RespondersFrom enrollment to the final follow-up visit (3-months following final treatment)
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).
- Change in Physician Global Aesthetic Improvement Scale (PGAIS)From enrollment to the final follow-up visit (3-months following final treatment)
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. 1. \- Worse: The patient's aesthetic appearance has deteriorated compared to baseline 2. \- No Change: There is no noticeable difference from the pre-treatment state. 3. \- Improved: The physician notes a visible enhancement, but further treatment could still be beneficial 4. \- Much Improved: There is a marked, clear aesthetic improvement 5. \- Very Much Improved: An optimal cosmetic result has been achieved