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Consumer Clinical Results · Independent Laboratory Substantiation
SeneGence
Clinical Evaluation Report
ETC Panel No. 23076
ETC Entry No. 50474
Clinical Evaluation Report

A One-Day Evaluation of LipSense® Cream

Long-wear, low-transfer, and brief water-exposure performance of a lip color.
Sponsor
SeneGence International, Inc.
Test Facility
Essex Testing Clinic (ETC) - Verona, New Jersey, USA
Design
1-day, single-arm clinical use study with long-wear, transfer-proof and water-proof evaluations
Population
32 female subjects, ages 19-50, enrolled and completed
Conducted under
Good Clinical Practice, informed consent and ETC Standard Operating Procedures
Evaluation points
Baseline; 4, 6 and 8 hours; after rubbing; and after 30-second water exposure
Tested product. LipSense Cream - identified in the signed Essex source as LipSense Hydra Matte Lip Color.
Conducted by Essex Testing Clinic (ETC), an independent claim-substantiation laboratory. Final report dated April 4, 2023.
SeneGence

SeneGence International, Inc. · Independent Clinical Substantiation

§ Synopsis

In a 1-day study of 32 women, Essex evaluated LipSense Cream under the source name LipSense Hydra Matte Lip Color. Mean appearance scores remained in the study's "good appearance" category at 4 hours: 3.2 by trained-technician assessment and 3.4 by participant assessment on a 0-to-4 scale.

The transfer assessment produced a mean transference score of 0.4 after rubbing, near the scale's "no evidence" category, although slight transference was observed. After 30 seconds of water exposure, all technician and subject mean appearance scores remained unchanged at 4.0 for both lips and forearm.

3.2 / 3.4
4-hour appearance

Technician / subject means; both in the "good" category.

0.4
Transfer score

Mean after rubbing on a white towel; scale range 0-9.

4.0
After water

All lip and forearm means remained "excellent."

1 Objectives & Methods

1.1 Objectives

To determine the long-wear potential of the lip color at 4, 6 and 8 hours after application, and to evaluate its transfer-proof and water-proof potential under the study protocols.

1.2 Test article

  • LipSense Cream, identified in the source report as LipSense Hydra Matte Lip Color
  • Physical description: mauve cream

1.3 Use & assessments

  • Applied to clean, dry lips and allowed to dry without pressing lips together
  • Lip appearance scored by a trained technician and each subject on a 0-to-4 scale
  • Transfer assessed by rubbing a white towel over a forearm test site
  • Water exposure assessed on lips and a forearm test site for approximately 30 seconds

1.4 Claim criteria & analysis

The report used descriptive mean scores and prespecified category thresholds; it did not present statistical hypothesis testing. No control or comparator, randomization or blinding was reported. A long-wear or water-proof claim was considered supported when the applicable mean was in or near the "good appearance" category or above (2.5-4.0). A transfer-proof claim was considered supported when the mean was in or near the "slight transference" category (0-3).

Appearance scale: 4 = excellent; 3 = good; 2 = fair; 1 = poor; 0 = no product visible. Transfer scale: 0 = no evidence; 1-3 = slight; 4-6 = moderate; 7-9 = severe transference.

2 Results - Long-wear Evaluation

Mean appearance scores on lips; higher score = better visible product appearance.

TimepointTechnician meanSubject meanStudy category
Baseline4.04.0Excellent
4 hours3.23.4Good
6 hours1.92.3Fair / near fair
8 hours0.81.0Poor / near poor
Interpretation. The 4-hour means remained above the prespecified 2.5 threshold, supporting a 4-hour long-wear claim. The 6- and 8-hour means were below that threshold.

3 Results - Transfer & Water Exposure

3.1 Transfer evaluation

Approximately 5 minutes after application to a 2 cm by 2 cm forearm test site, a technician gently rubbed the site with a white towel and scored product transference.

AssessmentMean scoreScaleSource-report observation
After rubbing0.40-9Slight transfer; mean near 0

Individual scores: 18 subjects scored 0 and 14 scored 1; no score exceeded 1. The source report concluded that the claim "transfer-proof" was supported under this forearm protocol.

3.2 Brief water-exposure evaluation

Five minutes after application, lips were splashed with water and forearms were submerged in 27 degrees C water, each for approximately 30 seconds.

Test siteAssessorBaselineAfter waterChange
LipsTechnician4.04.00.0
LipsSubjects4.04.00.0
ForearmTechnician4.04.00.0
ForearmSubjects4.04.00.0

Every mean remained in the "excellent appearance" category. The source report concluded that a "water-proof" claim was supported under these protocols.

4 Conclusion

Under the conditions of this 32-subject study, LipSense® Cream met the report's criterion for a 4-hour long-wear claim. The forearm assessment showed low transfer after rubbing, and appearance scores were unchanged after 30 seconds of water exposure on lips and forearm. In the signed source report, Essex Testing Clinic concluded that 4-hour long-wear, "transfer-proof," and "water-proof" claims were supported under those specified procedures.

Gabriela ArguetaProject Manager / Study Director
Essex Testing Clinic, Inc.
Toni F. Miller, PhD, DABT, BCFEScientific Director / Principal Investigator
Essex Testing Clinic, Inc.