SeneGence International, Inc. · Independent Clinical Substantiation
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.
Technician / subject means; both in the "good" category.
Mean after rubbing on a white towel; scale range 0-9.
All lip and forearm means remained "excellent."
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.
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.
Mean appearance scores on lips; higher score = better visible product appearance.
| Timepoint | Technician mean | Subject mean | Study category |
|---|---|---|---|
| Baseline | 4.0 | 4.0 | Excellent |
| 4 hours | 3.2 | 3.4 | Good |
| 6 hours | 1.9 | 2.3 | Fair / near fair |
| 8 hours | 0.8 | 1.0 | Poor / near poor |
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.
| Assessment | Mean score | Scale | Source-report observation |
|---|---|---|---|
| After rubbing | 0.4 | 0-9 | Slight 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.
Five minutes after application, lips were splashed with water and forearms were submerged in 27 degrees C water, each for approximately 30 seconds.
| Test site | Assessor | Baseline | After water | Change |
|---|---|---|---|---|
| Lips | Technician | 4.0 | 4.0 | 0.0 |
| Lips | Subjects | 4.0 | 4.0 | 0.0 |
| Forearm | Technician | 4.0 | 4.0 | 0.0 |
| Forearm | Subjects | 4.0 | 4.0 | 0.0 |
Every mean remained in the "excellent appearance" category. The source report concluded that a "water-proof" claim was supported under these protocols.
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.