A Prospective, Single-center, Single-blind, Randomized split-face, controlled trial will be conducted. The goal of this clinical trial is to evaluate the efficacy and safety of monopolar radiofrequency combined with SkinCeuticals A.G.E and Skinceuticals CE FERULIC for improving facial skin elasticity, tightening and fading fine lines
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Enrollment
50
Each subject underwent monopolar radiofrequency treatment (Thermage FLX ™ ) on both sides of the face
Test Side receives SkinCeuticals A.G.E and Skinceuticals CE FERULIC
Control Side applies Standard Cream
Global aesthetic improvement scale (GAIS) score
Investigator Satisfaction Assessment Form. Scoring criteria: 3 (very much improved), 2 (marked improvement), 1 (improved), 0 (no change), or -1 (worse).
Time frame: at day 90 after procedure
Global aesthetic improvement scale (GAIS) score
Investigator Satisfaction Assessment Form. Scoring criteria: 3 (very much improved), 2 (marked improvement), 1 (improved), 0 (no change), or -1 (worse).
Time frame: at 30, 60 days after procedure
Improvement of skin glossiness
Skin glossiness was assessed by an independent investigator on both sides of the face (three measurements averaged) according to DermaLab ® Combo (Multipurpose Skin Detector, Cortex) + Chromaticity Test Probe
Time frame: at 30, 60, 90 days after procedure
Improvement in skin elasticity and tightness
Skin elasticity was assessed by an independent investigator on both sides of the face (averaged over three measurements) according to the DermaLab ® Combo + Elastic Probe
Time frame: at 30, 60, 90 days after procedure
Improvement in dermal thickness/density
Dermal thickness/density was assessed on both sides of the face (averaged over three measurements) by an independent investigator using the DermaLab ® Combo + HF ultrasound probe
Time frame: at 30, 60, 90 days after procedure
Improvement of transepidermal water loss (TEWL)
TEWL was assessed by an independent investigator on both sides of the face (three measurements averaged) according to the DermaLab ® Combo + TEWL test probe
Time frame: at 30, 60, 90 days after procedure
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Improvement of skin stratum corneum water content
Skin stratum corneum moisture was assessed on both sides of the face (three measurements averaged) by an independent investigator using the DermaLab ® Combo + Moisture Testing Probe
Time frame: at 30, 60, 90 days after procedure
Improvement in fine lines score
Skin Parameter Assessment Form. Fine lines: Grading was performed on a Griffith 's scale (10-point scale) with different scores representing: 0 (no fine lines/wrinkles, skin completely smooth and no wrinkles); 1-3 (mild, few fine lines and wrinkles, and distant intervals within the treatment area); 4-6 (moderate, moderate number of fine lines/wrinkles within the treatment area and close to each other); and 7-9 (severe, dense clusters of fine lines/wrinkles within the treatment area). Fine lines status should be evaluated by an independent investigator.
Time frame: at 30, 60, 90 days after procedure
Subject satisfaction evaluation
Subject Satisfaction Assessment Form. 1: very dissatisfied, 2: dissatisfied, 3: fair, 4: satisfied, and 5: very satisfied, and the proportion of people in each rating was statistically summarized
Time frame: at 30, 60, 90 days after procedure