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New treatment option for Photodamaged Skin
Official title 2910 nm Erbium-Doped Fluoride Fiber Glass Laser for the Treatment of Advanced Perioral Lines and Wrinkles
ClinicalTrials.gov ID: NCT07222397
What this study is testing
- What it's testing
- 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).
- This is a blinded study.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 50 to 80
You may be able to join if
- Fitzpatrick skin type I-IV.
- Male or female.
- people must be between 50 and 80 years of age.
- people must have the ability to receive up to two full face resurfacing laser treatment with specific focus on advanced perioral lines and wrinkles.
- people must read, understand, and sign the Informed Consent Form.
You likely can't join if
- people must not have active localized or systemic infections.
- people must not have a compromised ability for wound healing, such as: malnutrition, steroid use, history of collagen vascular disease (e.g., lupus...
- people must not have had treatments with 5FU, diclofenac, imiquimod, steroids, retinoids, or PDT within 1-month prior to enrollment.
- people must not currently be taking Accutane or have taken Accutane within the last 1-month.
- people must not have a known allergy to lidocaine or epinephrine, topical or injectable products containing lidocaine or any numbing medications.
- people must not have had previous surgery and/or fat transfer in the treatment area within the last 6-months.
See the full eligibility criteria
Who can join
- Fitzpatrick skin type I-IV.
- Male or female.
- people must be between 50 and 80 years of age.
- people must have the ability to receive up to two full face resurfacing laser treatment with specific focus on advanced perioral lines and wrinkles.
- people must read, understand, and sign the Informed Consent Form.
- people must be willing and able to comply with all follow-up visit requirements.
- people must agree to refrain from using cosmeceutical agents or topical agents during the study, except as directed by study investigator.
- people 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.
- people 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.
What rules you out
- people must not have active localized or systemic infections.
- people 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...
- people must not have had treatments with 5FU, diclofenac, imiquimod, steroids, retinoids, or PDT within 1-month prior to enrollment.
- people must not currently be taking Accutane or have taken Accutane within the last 1-month.
- people must not have a known allergy to lidocaine or epinephrine, topical or injectable products containing lidocaine or any numbing medications.
- people 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.
- people 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.
- people 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.
- people must not be pregnant or breastfeeding, think they may be pregnant or are trying to get pregnant during the study.
The study team makes the final eligibility decision.
Where it's taking place
- Houston, Texas, United States
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 50 years to 80 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Houston, Texas, United States. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.