NCT05808842

Laser Treatment for Facial and Neck Rejuvenation

Evaluation of the UltraClear Laser Workstation for the Treatment of Facial and Neck Rejuvenation and Skin Resurfacing Augmented With Mesenchymal Stem Cell Extract

• Status: Unknown
• Phase: N/A
• Study type: Interventional
• Enrollment: 15 (estimated)
• Sponsor: Goldman, Butterwick, Fitzpatrick and Groff · Academic / Other
• Sex: All
• Age: 18 Years – 75 Years
• Healthy volunteers: Accepted

Summary

To assess the efficacy, safety, and patient satisfaction associated with the treatment of the face and neck with the 2,910nm mid-infrared UltraClear Laser System using both superficial epidermal ablation and deep ablative and coagulative capabilities in the dermis for rejuvenation of photodamaged skin. Additionally, this study will assess the additive value of a post-treatment skincare regimen consisting of a serum and cream containing red deer umbilical cord lining mesenchymal stem cell conditioned media for faster healing and more robust rejuvenation.

Detailed description

Subjects will be treated with the UltraClear 2,910nm mid-infrared laser using both superficial epidermal ablation and deep ablative and coagulative capabilities in the dermis for rejuvenation of photodamaged skin of the face and neck. Subjects will be randomized to have one of two post-laser skincare regimens which will be applied to the face and neck following laser treatment. All subjects will receive three (3) laser treatments to the face and neck using the UltraClear 2,910nm mid-infrared laser, performed 5 weeks ± 7 days apart.

Conditions

• Face Rejuvenation
• Neck Rejuvenation

Interventions

Type	Name	Description
OTHER	CeraVe	* CeraVe gentle facial cleanser (CeraVe; New York, NY) to be used morning and evening * CeraVe lotion (CeraVe; New York, NY) to be used morning and evening, reapply as needed for dry skin * A mineral CeraVe sunscreen (CeraVe; New York, NY) to be applied in the morning and reapplied every 2 hours if going outside
OTHER	CeraVe and Calecim	* CeraVe gentle facial cleanser (CeraVe; New York, NY) to be used morning and evening * Calecim® Professional Serum (CellResearch Corporation; Singapore) to be used morning and evening * Calecim® Restorative Hydration Cream (CellResearch Corporation; Singapore) to be used morning and evening, reapply as needed for dry skin * A mineral CeraVe sunscreen (CeraVe; New York, NY) to be applied in the morning and reapplied every 2 hours if going outside

Timeline

• Start date: 2023-04-03
• Primary completion: 2024-02-28
• Completion: 2024-02-28
• First posted: 2023-04-11
• Last updated: 2023-04-11

Regulatory

• FDA-regulated device study