Status:
RECRUITING
2910 nm Erbium-Doped Fluoride Fiber Glass Laser for the Treatment of Advanced Perioral Lines and Wrinkles
Lead Sponsor:
FA Corporation
Conditions:
Photodamaged Skin
Rhytids
Eligibility:
All Genders
50-80 years
Phase:
NA
Brief Summary
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...
Eligibility Criteria
Inclusion
- Fitzpatrick skin type I-IV.
- Male or female.
- Subjects must be between 50 and 80 years of age.
- Subjects must have the ability to receive up to two full face resurfacing laser treatment with specific focus on advanced perioral lines and wrinkles.
- Subjects must read, understand, and sign the Informed Consent Form.
- Subjects must be willing and able to comply with all follow-up visit requirements.
- Subjects must agree to refrain from using cosmeceutical agents or topical agents during the study, except as directed by study investigator.
- Subjects must be rated as Class II or Class III based on the Fitzpatrick Wrinkling and Degree of Elastosis Scale (FWS).
- Subject identified as an appropriate candidate for study treatment based on principal investigator's opinion.
- Subjects of childbearing potential have been on an acceptable form of contraception for 30 days prior to enrollment and agree to continue using throughout the course of the study.
Exclusion
- Subjects must not have active localized or systemic infections.
- Subjects must not have a compromised ability for wound healing, such as: malnutrition, steroid use, history of collagen vascular disease (e.g., lupus, scleroderma, history of keloid scar formation), atrophic dermatitis or immunologic abnormalities such as vitiligo.
- Subjects must not have had treatments with 5FU, diclofenac, imiquimod, steroids, retinoids, or PDT within 1-month prior to enrollment.
- Subjects must not currently be taking Accutane or have taken Accutane within the last 1-month.
- Subjects must not have a known allergy to lidocaine or epinephrine, topical or injectable products containing lidocaine or any numbing medications.
- Subjects must not have had previous surgery and/or fat transfer in the treatment area within the last 6-months.
- Subject must not have had injectable soft tissue fillers within the last 12 months in the treatment area.
- Subject must not have had Poly-L-Lactic acid (PLLA) fillers within the last 2 years in the treatment area.
- Subject must not have had permanent filler i.e., Polymethylmethacrylate (PMMA) in the treatment area.
- Subjects must not have had neurotoxins within the last 3-months in the treatment area.
- Subject must not have a personal history of any facial threads i.e., PDO (Polydioxanone), PLLA (Polylactic acid), PCL (Polycaprolactone) in the treatment area within the last 12 months.
- Subject must not have had a pulse dye or vascular laser, non-ablative laser, microneedling, or energy-based device treatment in the treatment area within the last 3 months.
- Subject must not have had an ablative laser treatment in the treatment area within the last 6 months.
- Subjects must not have a personal history of malignant melanoma, keloid scars, generalized psoriasis or systemic diseases that would preclude the use of topical anesthesia.
- Subject must not have active sunburn or excessively tanned skin.
- Subjects must not be pregnant or breastfeeding, think they may be pregnant or are trying to get pregnant during the study.
Key Trial Info
Start Date :
March 1 2025
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
February 1 2026
Estimated Enrollment :
20 Patients enrolled
Trial Details
Trial ID
NCT07222397
Start Date
March 1 2025
End Date
February 1 2026
Last Update
October 29 2025
Active Locations (1)
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1
Dermatology & Laser Surgery Center
Houston, Texas, United States, 77030