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

NCT ID: NCT05202834

Last Updated: 2022-01-24

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 3 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2021-07-15
• Study Completion Date: 2021-11-10

Brief Summary

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

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.

Conditions

Healthy

Study Design

• Observational Model Type: CASE_ONLY
• Study Time Perspective: PROSPECTIVE

Interventions

UltraClear

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

Intervention Type: DEVICE

Eligibility Criteria

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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• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 75 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

FA Corporation

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Shlomo Assa

Role: STUDY_DIRECTOR

FA Corporation

Locations

FA Corporation

Lincoln, Rhode Island, United States

Countries

United States

Other Identifiers

UC 10-2021

Identifier Type: -

Identifier Source: org_study_id