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

Healthy Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05202834
• Other study ID #: UC 10-2021
• Status: Completed
• Start date: July 15, 2021
• Est. completion date: November 10, 2021

Study information

• Verified date: January 2022
• Source: FA Corporation
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 3
• Est. completion date: November 10, 2021
• Est. primary completion date: October 12, 2021
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 75 Years

Eligibility

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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Related Conditions & MeSH terms

• Healthy

Intervention

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

Locations

Country	Name	City	State
United States	FA Corporation	Lincoln	Rhode Island

Sponsors (1)

Lead Sponsor	Collaborator
FA Corporation

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Histology Study of Laser Ablation on human skin	Histological specimens microscope ready slides	Immediate after treatment