Side Effects

CandyLipz Clinical Trial Class 4

CandyLipz lip plumper system does not cause bruising. It has been validated by our Clinical Trial Class 4 that the temporary side effect of cupping marks are actually erythema- superficial skin reddening. It does not cause bruising, broken blood vessels, vascular hemorrhage or broken red blood cells.

Over a 56-day period, the study evaluated approximately 50 women who were assigned use of the test device, in accordance with typical use instructions, and 25 women using the test device without suction (placebo control). As a control, the same device was used without the application of pressure.  In order to closely examine the biophysical, physiological, hematological and histological effects of lip cupping, this clinical trial evaluated treated skin by multiple clinical methodologies (see definitions at end below). We measured the appearance of dermal vasculature by image analysis, evidence of objective and subjective irritation, color of the lips and the area above the upper lip, blood perfusion, skin barrier properties and structural aspects of the treated lips and lip area skin by ultrasound and by histological analysis of treated skin tissue samples.

The image above shows cupping marks, 24 hours after device use. Whether mild, moderate or severe, these marks were transient and were not seen by Day 28 and through Day 56. In the treated group, the results showed 31% had no marks (1st image); 45% had mild marks (2nd image); 19 % had moderate marks (3rd image); and 5% had intense marks (4th image).

95% of subjects showed cupping marks resolved between Day 1 and Day 9.  By Day 56, lips appeared smooth and plumper.

Each of the following methods below demonstrated the system to be safe:

A total of 11 methodologies were carried out in the clinical study of cupping marks (Appendix 2): Blue Color Image Analysis , RGB Digital Imaging Analysis, Dermatologist Grading , Chromameter Readings, Laser Doppler Readings, Tewameter® TM300 (C+K, Germany) Measurements, Spectrophotometer measurements, Ultrasound Imaging, Primoslite High Resolution Small Field Capture Imaging, VISIA Contrast Image Analysis, and Subject questionnaire responses and Subject Satisfaction Scale.

You can learn more about the CandyLipz Clinical Trial here.

Individual results may vary.
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