Status:
COMPLETED
Evaluation of the UltraClear Laser Workstation for Skin Treatment - Histology Study of Laser Ablation on Human Skin
Lead Sponsor:
FA Corporation
Conditions:
Healthy
Eligibility:
All Genders
18-75 years
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 coagu...
Eligibility Criteria
Inclusion
- 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
- 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
- \-
Key Trial Info
Start Date :
July 15 2021
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
November 10 2021
Estimated Enrollment :
3 Patients enrolled
Trial Details
Trial ID
NCT05202834
Start Date
July 15 2021
End Date
November 10 2021
Last Update
January 24 2022
Active Locations (1)
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1
FA Corporation
Lincoln, Rhode Island, United States, 02865