Actively Recruiting

Phase Not Applicable
Age: 50Years - 80Years
All Genders
ID07222397

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

8 weeks

Total Duration

On this page

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 laser's 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 laser's 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

Eligible

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
Not Eligible

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

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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Your Study Journey

Screening

Duration - 2 to 4 weeks

Participants are screened for eligibility to participate in the trial.

1 visit (in-person)

Implementation

Duration - Up to two treatments over a few weeks

Participants receive treatment with the UltraClear 2,910nm mid-infrared laser targeting advanced perioral lines and wrinkles using superficial and deep ablative techniques for skin rejuvenation.

Up to 2 treatment visits (in-person)

Follow-up

Duration - 3 months

Participants are monitored for outcomes and safety for 3 months following their final laser treatment.

Several follow-up visits over 3 months

Trial Site Locations

Total: 1 location

1

Dermatology & Laser Surgery Center

Houston, Texas, United States, 77030

Actively Recruiting

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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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