Actively Recruiting
Evaluation of the 2910 nm Erbium-Doped Fluoride Fiber Glass Laser for the Treatment of Advanced Perioral Lines and Wrinkles
Led by FA Corporation · Updated on 2025-10-29
20
Participants Needed
1
Research Sites
48 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are evaluating the safety, effectiveness, and participant satisfaction of a 2,910 nm mid-infrared Fiber Laser (UltraClear, Acclaro Medical) for treating advanced perioral lines and wrinkles. This study focuses on skin rejuvenation through both superficial epidermis ablation and deeper dermal ablative and coagulative effects. The target population includes adults aged 50 to 80 with photodamaged skin and significant wrinkles around the mouth. Participants will undergo up to two laser resurfacing treatments spaced 6 to 8 weeks apart using the UltraClear laser device. These treatments aim to improve the appearance of perioral lines and wrinkles by targeting both the surface and deeper layers of the skin. After treatment, participants will return for follow-up visits at 1 month and 3 months to assess the laser's effectiveness and safety. During the study, participants will be evaluated using multiple scales, including the Fitzpatrick Wrinkling and Degree of Elastosis Scale, the Physician Global Aesthetic Improvement Scale, and assessments by blinded Independent Photographic Reviewers. Researchers will monitor safety, overall aesthetic improvement, and participant satisfaction from enrollment through the final follow-up visit three months after the last treatment.
CONDITIONS
Official Title
2910 nm Erbium-Doped Fluoride Fiber Glass Laser for the Treatment of Advanced Perioral Lines and Wrinkles
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Fitzpatrick skin type I-IV
- Male or female gender
- Age between 50 and 80 years
- Able to receive up to two full face resurfacing laser treatments focused on advanced perioral lines and wrinkles
- Able to read, understand, and sign the informed consent form
- Willing and able to comply with all follow-up visit requirements
- Agree to avoid cosmeceutical or topical agents during the study unless directed by the investigator
- Rated as Class II or Class III on the Fitzpatrick Wrinkling and Degree of Elastosis Scale
- Identified as an appropriate candidate for treatment by the principal investigator
- If of childbearing potential, using acceptable contraception for 30 days before enrollment and willing to continue during the study
You will not qualify if you...
- Active localized or systemic infections
- Compromised wound healing ability, such as malnutrition, steroid use, collagen vascular disease, atrophic dermatitis, or immunologic abnormalities
- Treatment with 5FU, diclofenac, imiquimod, steroids, retinoids, or PDT within 1 month prior to enrollment
- Current or recent (within 1 month) use of Accutane
- Known allergy to lidocaine, epinephrine, or numbing medications
- Surgery or fat transfer in the treatment area within the last 6 months
- Injectable soft tissue fillers in the treatment area within the last 12 months
- Poly-L-Lactic acid (PLLA) fillers in the treatment area within the last 2 years
- Permanent filler (PMMA) in the treatment area
- Neurotoxins in the treatment area within the last 3 months
- Facial threads in the treatment area within the last 12 months
- Pulse dye or vascular laser, non-ablative laser, microneedling, or energy-based device treatment in the treatment area within the last 3 months
- Ablative laser treatment in the treatment area within the last 6 months
- Personal history of malignant melanoma, keloid scars, generalized psoriasis, or systemic diseases contraindicating topical anesthesia
- Active sunburn or excessively tanned skin
- Pregnant, breastfeeding, or planning pregnancy during the study
AI-Screening
AI-Powered Screening
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Trial Site Locations
Total: 1 location
1
Dermatology & Laser Surgery Center
Houston, Texas, United States, 77030
Actively Recruiting
Research Team
M
Mary Dick, MD
L
Leah Dickerson
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
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