Evaluation of the UltraClear Laser Workstation for Skin Treatment - Histology Study of Laser Ablation on Human Skin

Evaluation of the UltraClear Laser Workstation for Skin Treatment - Histology Study of Laser Ablation on human skin

Study Overview

• Status: Completed
• Conditions: Healthy
• Intervention / Treatment: Device: UltraClear

Detailed Description

The study is being conducted to evaluate the safety and efficacy of the UltraClear Mid IR Fiber Laser Workstation using both superficial epidermis ablation capabilities and the deep ablative and coagulative capabilities into the dermis. Epidermis is the skin most outer layer that is supported by the dermis, which is the thick layer of living tissue below the epidermis which forms the true skin, containing blood capillaries, nerve endings, sweat glands, hair follicles, and other structures. Superficial ablative properties of the laser are the ability to remove thin and controlled layer of epidermis without damaging the underlaying layers of the skin, while the deep ablative properties of the laser are the ability to create a controlled and consistent mechanical and thermal injury in the skin that will lead to strong healing process that will improve the skin properties such as softness, elasticity and appearance. Round ø4.0 mm ( ~ø 1/8") Biopsies will be taken to examine the histologic effects of the treatments.

• Study Type: Observational
• Enrollment (Actual): 3

Contacts and Locations

Study Locations

• United States
  • Rhode Island
    • Lincoln, Rhode Island, United States, 02865
      • FA Corporation

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 75 years (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

Normal and healthy Subjects

Description

Inclusion Criteria:

-1. Fitzpatrick skin type I-VI. 2. Male or female. 3. Subjects must be between 25 and 75 years of age. 4. Subjects must have ability to get treatment and biopsy from tissue in the abdomen or Buttock.

5. Subjects must read, understand, and sign the Informed Consent. 6. Subjects must be willing and able to comply with all follow-up requirements.

Exclusion Criteria:

1. Subjects must not have active localized or systemic infections.
2. Lidocaine or epinephrine allergy.
3. 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.
4. Subjects must not have had treatments with 5FU, hydroquinone, diclofenac, imiquimod, retinoids, or PDT within one month prior to enrollment.
5. Subjects must not currently be taking Accutane, or have taken Accutane within the last 6 months.
6. Subjects must not have a known allergy to the following topical products: lidocaine (numbing cream).
7. Subject must not have used topical steroids or retinoids within the last 3 months on treatment surfaces.
8. 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.
9. Subjects must agree to refrain from using cosmeceutical agents or topical agents during the course of the study, except as directed by study investigators.
10. Subjects must not be pregnant or breastfeeding.

11. Active sunburn or excessively tanned skin

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Study Plan

How is the study designed?

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Histology Study of Laser Ablation on human skin	Histological specimens microscope ready slides	Immediate after treatment

Collaborators and Investigators

• Sponsor: FA Corporation
• Investigators: Study Director: Shlomo Assa, FA Corporation

Study record dates

Study Major Dates

• Study Start (ACTUAL): July 15, 2021
• Primary Completion (ACTUAL): October 12, 2021
• Study Completion (ACTUAL): November 10, 2021

Study Registration Dates

• First Submitted: January 10, 2022
• First Submitted That Met QC Criteria: January 10, 2022
• First Posted (ACTUAL): January 24, 2022

Study Record Updates

• Last Update Posted (ACTUAL): January 24, 2022
• Last Update Submitted That Met QC Criteria: January 10, 2022
• Last Verified: January 1, 2022

More Information

Terms related to this study

• Other Study ID Numbers: UC 10-2021

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO
• IPD Plan Description: No plans to share individual participant data

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes
• product manufactured in and exported from the U.S.: No