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.
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 Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
30
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.
UT Southwestern Department of Plastic Surgery
Dallas, Texas, United States
Change in Dyspigmentation Spots
Numeric analysis of dyspigmentation (spots) will be analyzed using VISIA System. The change from baseline was calculated at Month 1 and Month 3. An increase in the absolute count would indicate improvement.
Time frame: Baseline, Month 1 and Month 3
Change in UV Spots
Numeric analysis of lesions resulting from photodamage will be analyzed using VISIA System. The change from baseline was calculated at Month 1 and Month 3. An increase in the absolute count would indicate improvement.
Time frame: Baseline, Month 1 and Month 3
Change in Brown Spots
Numeric analysis of lentigines and melasma will be analyzed using the VISIA system. The change from baseline was calculated at Month 1 and Month 3. An increase in the absolute count would indicate improvement.
Time frame: Baseline, Month 1 and Month 3
Physician's Global Assessment Scores (PGAS)- Right Face
Clinician evaluators assessed the right side of each participants 1 and 3 month photographs to subjectively score clinical improvement. PGAS Score Description 0 Clear, except for possible residual discoloration, 100% improvement. 1. Almost clear, very significant clearance, 90% improvement; only minor evidence of hyperpigmentation remains. 2. Marked improvement, significant improvement, 75% improvement. Some disease evidence of hyperpigmentation remains. 3. Moderate improvement, intermediate between slight and marked improvement; 50% improvement in appearance of hyperpigmentation 4. Slight improvement, some improvement, 25% improvement; significant evidence of hyperpigmentation remains 5. No improvement; hyperpigmented condition unchanged 6. Worse; condition worse than at week 0
Time frame: Month 1 and Month 3
Physician's Global Assessment Scores (PGAS)- Left Face
Clinician evaluators assessed the left side of each participants 1 and 3 month photographs to subjectively score clinical improvement. PGAS Score Description 0 Clear, except for possible residual discoloration, 100% improvement. 1. Almost clear, very significant clearance, 90% improvement; only minor evidence of hyperpigmentation remains. 2. Marked improvement, significant improvement, 75% improvement. Some disease evidence of hyperpigmentation remains. 3. Moderate improvement, intermediate between slight and marked improvement; 50% improvement in appearance of hyperpigmentation 4. Slight improvement, some improvement, 25% improvement; significant evidence of hyperpigmentation remains 5. No improvement; hyperpigmented condition unchanged 6. Worse; condition worse than at week 0
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Time frame: Month 1 and Month 3
Physician's Global Assessment Score (PGAS)- Overall
Clinician evaluators assessed 1 and 3 month photographs to subjectively score clinical overall improvement. PGAS Score Description 0 Clear, except for possible residual discoloration, 100% improvement. 1. Almost clear, very significant clearance, 90% improvement; only minor evidence of hyperpigmentation remains. 2. Marked improvement, significant improvement, 75% improvement. Some disease evidence of hyperpigmentation remains. 3. Moderate improvement, intermediate between slight and marked improvement; 50% improvement in appearance of hyperpigmentation 4. Slight improvement, some improvement, 25% improvement; significant evidence of hyperpigmentation remains 5. No improvement; hyperpigmented condition unchanged 6. Worse; condition worse than at week 0
Time frame: Month 1 and Month 3