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2910 nm Erbium-Doped Fluoride Fiber Glass Laser for the Treatment of Advanced Perioral Lines and Wrinkles | Clinical Trials | Clareo Health

RECRUITINGNA

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

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

NCT07222397•FA Corporation

View on ClinicalTrials.gov

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, 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). Additionally, safety, subjective overall aesthetic improvement and satisfaction will be monitored and tracked.

Eligibility

Age

50 - 80 years

Sex

ALL

Healthy Volunteers

Inclusion Criteria

•1. Fitzpatrick skin type I-IV.
•2. Male or female.
•3. Subjects must be between 50 and 80 years of age.
•4. Subjects must have the ability to receive up to two full face resurfacing laser treatment with specific focus on advanced perioral lines and wrinkles.
•5. Subjects must read, understand, and sign the Informed Consent Form.
•6. Subjects must be willing and able to comply with all follow-up visit requirements.
•7. Subjects must agree to refrain from using cosmeceutical agents or topical agents during the study, except as directed by study investigator.
•8. Subjects must be rated as Class II or Class III based on the Fitzpatrick Wrinkling and Degree of Elastosis Scale (FWS).
•9. Subject identified as an appropriate candidate for study treatment based on principal investigator's opinion.
•10. 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 Criteria

•1. Subjects must not have active localized or systemic infections.
•2. 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.
•3. Subjects must not have had treatments with 5FU, diclofenac, imiquimod, steroids, retinoids, or PDT within 1-month prior to enrollment.
•4. Subjects must not currently be taking Accutane or have taken Accutane within the last 1-month.
•5. Subjects must not have a known allergy to lidocaine or epinephrine, topical or injectable products containing lidocaine or any numbing medications.
•6. Subjects must not have had previous surgery and/or fat transfer in the treatment area within the last 6-months.
•7. Subject must not have had injectable soft tissue fillers within the last 12 months in the treatment area.
•8. Subject must not have had Poly-L-Lactic acid (PLLA) fillers within the last 2 years in the treatment area.
•9. Subject must not have had permanent filler i.e., Polymethylmethacrylate (PMMA) in the treatment area.
•10. Subjects must not have had neurotoxins within the last 3-months in the treatment area.
+6 more criteria

Locations (1)

Dermatology & Laser Surgery Center

Houston, Texas, United States

Key Dates

Start Date

March 1, 2025

Primary Completion Date

December 1, 2025

Completion Date

February 1, 2026

Last Updated

October 29, 2025

Enrollment

ESTIMATED participants

Conditions

Photodamaged SkinRhytidsLines SkinWrinkles and Rhytides

Interventions

Laser Resurfacing

DEVICE

Contacts

Mary Dick, MD

CONTACT

713-900-3900 drdick@dermlasersurgery.com

Leah Dickerson

CONTACT

leah@dermlasersurgery.com

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: October 29, 2025Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

View ClinicalTrials.gov Terms and Conditions

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

Inclusion Criteria

Exclusion Criteria

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