What is the 2910 nm Erbium-Doped Fluoride Fiber Glass Laser studying for perioral lines and wrinkles?

This trial is evaluating a laser treatment designed to improve advanced lines and wrinkles around the mouth by resurfacing the skin. Researchers aim to assess how well the laser works, its safety, and participant satisfaction with the treatment. The study is sponsored by FA Corporation and focuses on skin rejuvenation for photodamaged skin and wrinkles.

Who may be eligible for this photodamaged skin clinical trial?

Adults aged 50 to 80 years with Fitzpatrick skin types I to IV and advanced perioral lines and wrinkles may be eligible. Both males and females can participate. Participants must be able to receive two laser treatments and follow study requirements. Please review eligibility criteria for more details.

Is there any cost to participate in this photodamaged skin clinical trial?

Study-related care, including the study laser treatment and all trial visits, is provided at no cost. However, personal travel expenses may vary and are not guaranteed to be covered. Participants should plan accordingly for any travel costs.

Actively Recruiting

Phase Not Applicable

Age: 50Years - 80Years

All Genders

ID07222397

Study of UltraClear 2910 nm Mid-Infrared Laser for Treating Advanced Perioral Lines and Wrinkles in Adults Aged 50 to 80

Led by FA Corporation · Updated on 2025-10-29

Participants Needed

Research Sites

8 weeks

Total Duration

AI-Summary

What this Trial Is About

Researchers are studying the use of a 2,910 nm mid-infrared Fiber Laser UltraClear, Acclaro Medical to treat advanced perioral lines and wrinkles. The goal is to assess the lasers effectiveness for skin rejuvenation by using both superficial epidermis ablation and deeper skin layers ablative and coagulative effects. The study also aims to evaluate safety and participant satisfaction with this resurfacing treatment for photodamaged skin and wrinkles. Participants will receive up to two treatments with the UltraClear laser, spaced 6 to 8 weeks apart. These treatments focus on improving the appearance of perioral lines and wrinkles using the lasers combined superficial and deep skin effects. Following treatments, participants will have follow-up visits at 1 month and 3 months to evaluate the results and any side effects. Throughout the study, researchers will measure improvements using multiple scales, including the Fitzpatrick Wrinkling and Degree of Elastosis Scale, Physician Global Aesthetic Improvement Scale, and assessments by independent photographic reviewers. Participants will also report their own perceptions of aesthetic improvement and satisfaction. Safety and overall aesthetic outcomes will be monitored during follow-ups, with the total participation lasting through the 3 months after the final treatment.

CONDITIONS

Brief Title

2910 nm Erbium-Doped Fluoride Fiber Glass Laser for the Treatment of Advanced Perioral Lines and Wrinkles

Who Can Participate

Age: 50Years - 80Years

All Genders

Eligibility Criteria

You may qualify if you...

Fitzpatrick skin type I-IV
Male or female
Aged 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 visits
Agree to avoid using cosmeceutical or topical agents during the study unless directed by the investigator
Rated as Class II or III on the Fitzpatrick Wrinkling and Degree of Elastosis Scale
Considered an appropriate candidate for the treatment by the principal investigator
If of childbearing potential, using acceptable contraception 30 days prior to enrollment and throughout the study

You will not qualify if you...

Active localized or systemic infections
Impaired wound healing ability, including malnutrition, steroid use, collagen vascular diseases, atrophic dermatitis, or immunologic abnormalities
Treatments 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
Facial surgery or fat transfer in the treatment area within the last 6 months
Injectable soft tissue fillers in treatment area within the last 12 months
Poly-L-Lactic acid fillers in treatment area within the last 2 years
Permanent fillers like Polymethylmethacrylate in treatment area
Neurotoxins in treatment area within the last 3 months
Facial threads in treatment area within the last 12 months
Pulse dye, vascular, non-ablative laser, microneedling, or energy-based device treatment in treatment area within last 3 months
Ablative laser treatment in treatment area within last 6 months
History of malignant melanoma, keloid scars, generalized psoriasis, or systemic diseases preventing topical anesthesia use
Active sunburn or excessive tanning
Pregnant, breastfeeding, trying to get pregnant, or suspect pregnancy during the study

Research Team

Mary Dick, MD

Leah Dickerson

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Study of UltraClear 2910 nm Mid-Infrared Laser for Treating Advanced Perioral Lines and Wrinkles in Adults Aged 50 to 80

On this page

AI-Summary

What this Trial Is About

Brief Title

Who Can Participate

Eligibility Criteria

Research Team

Not the Right Trial for You?

On this page

Who Can Participate

Eligibility Criteria