Recruiting

UltraClear Fiber Laser

Sponsor:

FA Corporation

Code:

NCT07222397

Conditions

Photodamaged Skin

Rhytids

Lines Skin

Wrinkles and Rhytides

Eligibility Criteria

Sex: All

Age: 50 - 70+

Healthy Volunteers: Not accepted

Interventions

Laser Resurfacing

Study Details

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, 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.

Conditions

Photodamaged Skin

Rhytids

Lines Skin

Wrinkles and Rhytides

Study ID

NCT07222397

Start date

Mar 1, 2025

Status verified date

Oct, 2025

Completion date

Feb, 2026

Anticipated

Primary completion date

Dec, 2025

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 50 - 70+

Healthy Volunteers: Not accepted

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.
11. 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.
12. 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.
13. Subject must not have had an ablative laser treatment in the treatment area within the last 6 months.
14. 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.
15. Subject must not have active sunburn or excessively tanned skin.
16. Subjects must not be pregnant or breastfeeding, think they may be pregnant or are trying to get pregnant during the study.

Study Design

Enrollment

20 participants

Anticipated

Intervention Model

Single group

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: Part 2 Clinical Study Procedure

UltraClear 2,910nm mid-infrared laser using both superficial epidermal ablation and deep ablative and coagulative capabilities in the dermis for rejuvenation addressing perioral lines and wrinkles.

Interventions

Laser Resurfacing

Enrolled participants will be treated with the UltraClear 2,910nm mid-infrared laser using both superficial epidermal ablation and deep ablative and coagulative capabilities in the dermis for rejuvenation with a specific focus on perioral lines and wrinkles.

Primary outcome measure

  • Change in Fitzpatrick Wrinkling and Degree of Elastosis Scale (FWS) [ Time Frame: From enrollment to the final follow-up visit (3-months following final treatment) ]
  • Percentage of Treatment Responders [ Time Frame: From enrollment to the final follow-up visit (3-months following final treatment) ]
  • Change in Physician Global Aesthetic Improvement Scale (PGAIS) [ Time Frame: From enrollment to the final follow-up visit (3-months following final treatment) ]

Central Contacts and Locations

Locations

Dermatology & Laser Surgery Center

Recruiting

Houston, Texas, United States, 77030

More Information

Sponsor

FA Corporation

Last update posted

Oct 29, 2025

Last verified

Oct, 2025

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-08. This information was provided to ClinicalTrials.gov by FA Corporation on 2025-10-29.