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

NCT05202834 | Completed FDA Device

• 1 other identifier: UC 10-2021
• Study Type: observational
• Target: 3
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Healthy

Outcome Measures

Primary Outcomes (1)

• Histology Study of Laser Ablation on human skin

  Histological specimens microscope ready slides

  Immediate after treatment

Interventions

UltraClear DEVICE

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

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Normal and healthy Subjects

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• FA Corporation: lead

Study Sites (1)

FA Corporation

Lincoln, Rhode Island, 02865, United States

Location

Study Officials

• Shlomo Assa

  FA Corporation

  STUDY DIRECTOR

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 10, 2022
• First Posted: January 24, 2022
• Study Start: July 15, 2021
• Primary Completion: October 12, 2021
• Study Completion: November 10, 2021
• Last Updated: January 24, 2022

Record last verified: 2022-01

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)