Clinical Trials Logo

Clinical Trial Summary

This is a single-site, non-randomized, non-controlled study at UT Southwestern Medical Center at Dallas in the Department of Plastic Surgery designed to follow up to 30 qualified and consenting subjects receiving a fractionated 1927 combination treatments for diffuse hyperpigmentation and/or melasma. Patients will receive treatment using f1927 devices and will be treated twice over the affected areas, once each month for a total of two months, followed by two follow-up visits at 1-month and 3-months post-treatment.


Clinical Trial Description

This is a prospective, non-controlled study where subjects will receive treatment using f1927 devices and will be treated twice over the affected areas of the face once each month for a total of two months. Patients will be evaluated at 1-month and 3-months post-treatment to monitor the clinical effects of treatment. Overall assessment of treatment efficacy will be based on evaluation of standard and close-up photography using pre- and post-procedural photos as well as images obtained by the Vectra H2 3D Imaging System. Baseline changes in the visualization and numeric analysis of pigmented areas will be evaluated utilizing the 3D Facial Skin Analysis software on the H2 System. Subjects will also undergo non-invasive skin measurements using optical coherence tomography (OCT) to noninvasively gather topographical and histological images of pre- and post-treated skin. Screening, treatment(s) with f1927, and OCT measurements are all for research purposes. ;


Study Design


Related Conditions & MeSH terms


NCT number NCT05226104
Study type Interventional
Source University of Texas Southwestern Medical Center
Contact
Status Completed
Phase N/A
Start date May 18, 2022
Completion date September 28, 2022

See also
  Status Clinical Trial Phase
Recruiting NCT06144541 - Correlation Between Objective Skin Pigment Measurement and Fitzpatrick Skin Type
Completed NCT03421691 - A Single-Center Open-Label Study of 1064 nm for Nonablative Skin Rejuvenation N/A
Recruiting NCT03022773 - Macular Pigment Measurements in Eye & Other Tissues N/A
Completed NCT05646953 - Safety and Efficacy Study of Vasu Facial Beauty Oil N/A
Withdrawn NCT03862872 - Effects of Bend Beauty's Anti-Aging Formula on Inflammatory Markers N/A
Completed NCT03530787 - Cosmetic Effects of Topical Acetyl Zingerone N/A
Recruiting NCT05554510 - Pulse Oximetry Errors in Hospitalized Patients Across Varying Skin Pigmentation
Recruiting NCT06063148 - Neonatal Pulse Oximetry Disparities Due to Skin Pigmentation N/A