Good-looking color at Hour Four.
SeneGence International, Inc. · Independent Clinical Substantiation
§ Synopsis
In a one-day study of 32 women, mean LipSense® Cream appearance scores stayed 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. Transfer and brief water-exposure endpoints were measured separately.
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."
See the product results in one view.
Compare the product, timing, and measured result in the diagrams below.
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 (formerly HydraMatte)
- 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.
| 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 |
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.
| 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.
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 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.
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.
Essex Testing Clinic, Inc.
Essex Testing Clinic, Inc.
Accessible source-page companion
PDF pages 6–16 are image facsimiles. This companion follows their page order, summarizes narrative passages, and transcribes the reported score tables, timepoints, scales, and units for screen-reader, keyboard, and search access.
The source reports 32 female participants ages 19 to 50 years. Lip color appearance was evaluated at baseline and 4, 6, and 8 hours, after towel rubbing, and after brief water exposure.
Administrative report and study identifiers are omitted here. The unchanged signed source PDF remains available above. The tested product is identified publicly as LipSense® Cream, formerly HydraMatte.
PDF page 6 — Final report cover
Final Report
Clinical Evaluation of the Wear Properties of a Lipstick
Tested product: LipSense® Cream, formerly HydraMatte.
Sponsor
SeneGence International
19651 Alter
Foothill Ranch, CA 92610
Sponsor Representative
Nikki Chew
Clinical Testing Facility
Essex Testing Clinic, Inc.
799 Bloomfield Avenue
Verona, NJ 07044
Date of Final Report: April 4, 2023.
Footer: 799 Bloomfield Avenue · Verona, NJ 07044 · (973) 857-9541 · Fax (973) 857-9662.
PDF page 7 — Signature page
Signature Page
Clinical Evaluation of the Wear Properties of a Lipstick
Tested product: LipSense® Cream, formerly HydraMatte.
- Gabriela Argueta, Project Manager and Study Director — signed March 31, 2023.
- Toni F. Miller, PhD, DABT, BCFE, Scientific Director and Principal Investigator — signed March 31, 2023.
Essex Testing Clinic, Inc.
PDF page 8 — Quality Assurance statement
Quality Assurance Statement
The study was conducted in accordance with the intent and purpose of Good Clinical Practice regulations described in 21 CFR Part 50, Protection of Human Subjects — Informed Consent, and the Standard Operating Procedures of Essex Testing Clinic, Inc.
For this clinical study, informed consent was obtained. An IRB review was not required.
The Quality Assurance Unit audited the applicable study records and report for protocol compliance. The report is considered a true and accurate reflection of the testing methods and source data.
Sherri L. Sayles, MS, Manager, Quality Assurance — signed March 31, 2023. Essex Testing Clinic, Inc.
PDF page 9 — Table of contents
Table of Contents
- 1.0 Objectives — page 1
- 2.0 Sponsor — page 1; 2.1 Sponsor Representatives — page 1
- 3.0 Clinical Investigators — page 1
- 4.0 Clinical Testing Facility — page 1
- 5.0 Study Date — page 1
- 6.0 Ethics — page 2; 6.1 Ethical Conduct of the Study — page 2; 6.2 Subject Information and Consent — page 2
- 7.0 Test Article — page 2
- 8.0 Test Subjects — page 2
- 9.0 Study Design — page 3; 9.1 Subject Selection — page 3; 9.1.1 Inclusion Criteria — page 3; 9.1.2 Exclusion Criteria — page 3
- 9.2 Test Procedure — page 4; 9.2.1 Long-wear Evaluation — page 4; 9.2.2 Transfer-proof Evaluation — page 4; 9.2.3 Water-proof Evaluation — page 5
- 10.0 Results and Discussion — page 5; 10.1 Long-wear Evaluation — page 5; 10.2 Transfer-proof Evaluation — page 6; 10.3 Water-proof Evaluation — page 6
- 11.0 Conclusions — page 7
- Appendix 1 — Subject Demographics
- Appendix 2 — Long-wear Evaluation
- Appendix 3 — Transfer-proof Evaluation
- Appendix 4 — Water-proof Evaluation
PDF page 10 — Final report, page 1 of 7: objectives, sponsor, investigators, facility, and date
Clinical Evaluation of the Wear Properties of a Lipstick
Tested product: LipSense® Cream, formerly HydraMatte.
1.0 Objectives
The objectives were to determine the lipstick’s long-wear potential 4, 6, and 8 hours post-application, determine whether it was transfer-proof, and determine its water-proof potential in a panel of 30 female volunteers between 18 and 50 years old.
2.0 Sponsor
SeneGence International, 19651 Alter, Foothill Ranch, CA 92610. 2.1 Sponsor Representative: Nikki Chew.
3.0 Clinical Investigators
- Study Director: Gabriela Argueta, Project Manager.
- Principal Investigator: Toni F. Miller, PhD, DABT, BCFE, Scientific Director.
4.0 Clinical Testing Facility
Essex Testing Clinic, Inc., 799 Bloomfield Avenue, Verona, NJ 07044.
5.0 Study Date
Start and end: February 6, 2023.
PDF page 11 — Final report, page 2 of 7: ethics, test article, and planned participants
6.0 Ethics
6.1 Ethical Conduct. The study followed the intent and purpose of Good Clinical Practice regulations in Title 21 of the U.S. Code of Federal Regulations, the Declaration of Helsinki, and/or Essex Testing Clinic Standard Operating Procedures.
6.2 Subject Information and Consent. The study complied with CFR Title 21, Part 50. Each subject gave written informed consent before participation and received a copy.
7.0 Test Article
The test article was supplied by SeneGence International and received December 27, 2022. The record describes 35 pieces of a mauve cream. The public tested-product identity is LipSense® Cream, formerly HydraMatte.
8.0 Test Subjects
Enough female subjects ages 18 to 50 were to be empaneled for 30 to complete. Each was to read, understand, and sign an Informed Consent Form and complete a Medical History Form.
PDF page 12 — Final report, page 3 of 7: participant selection
9.0 Study Design — 9.1 Subject Selection
A sufficient number of women between 18 and 50 years, in general good health, were to be empaneled so approximately 30 completed. Each had to read, understand, and sign an Informed Consent Form and complete a Medical History Form.
9.1.1 Inclusion Criteria
- Women ages 18 to 50 years, in general good health, able to read, understand, and sign informed consent.
- Willing to participate, follow directions, and remain for the entire duration.
- Free of skin or lip conditions, or a history of them, that might interfere with the study’s purpose, conduct, or integrity.
- Regular users of lipstick.
9.1.2 Exclusion Criteria
- Pregnant, planning pregnancy, lactating, and/or nursing.
- Failure to meet inclusion criteria.
- Known sensitivity to cosmetic products.
- Systemic or topical anti-inflammatory agents, except OTC acetaminophen, ibuprofen, or aspirin, during the 5 days before testing.
- Unable to avoid those agents during the study, subject to the same exceptions.
PDF page 13 — Final report, page 4 of 7: application, long-wear scale, and transfer scale
9.2 Test Procedure
The 1-day design included long-wear, transfer-proof, and water-proof evaluations. Sponsor directions were: apply to clean, dry lips; once applied, do not press lips together; let dry.
9.2.1 Long-wear Evaluation
Subjects arrived without cosmetics on the face or lips and applied lipstick until its appearance scored 4. Immediately after application, both technician and subject scored appearance:
- 4 = Excellent appearance
- 3 = Good appearance
- 2 = Fair appearance
- 1 = Poor appearance
- 0 = No product visible
Scoring was repeated 4, 6, and 8 hours post-application. Baseline was compared with each later observation. A mean in or near the good category or above, defined as 2.5 to 4.0, supported a long-wear claim.
9.2.2 Transfer-proof Evaluation
After the 8-hour assessment, a technician marked one 2 cm × 2 cm site on each clean forearm and applied product until appearance was excellent. Approximately 5 minutes later, the technician gently rubbed the forearm with a white towel and scored transference:
- 0 = No evidence of any transference
- 1–3 = Slight transference visible
- 4–6 = Moderate transference visible
- 7–9 = Severe transference visible
A mean in or near the slight category, defined as 0–3, supported a transfer-proof claim.
PDF page 14 — Final report, page 5 of 7: water exposure and participant completion
9.2.3 Water-proof Evaluation
After the transfer assessment, the technician marked a 2 cm × 2 cm forearm site, applied product until appearance was excellent, and obtained immediate technician and subject scores. Subjects also applied the lipstick to their lips under supervision until the appearance score reached 4; both assessors scored the lips immediately.
Five minutes after lip application, subjects splashed water on the lips for approximately 30 seconds. Five minutes after forearm application, each subject submerged the forearm in 27°C water for approximately 30 seconds. Both evaluations were repeated.
The lip and forearm scales were identical: 4 = excellent, 3 = good, 2 = fair, 1 = poor, and 0 = no product visible. Baseline was compared with the post-water score. A mean in or near good or above, 2.5 to 4.0, supported a water-proof claim.
10.0 Results and Discussion
A total of 32 female subjects, ages 19 to 50, enrolled and completed on January 13, 2023.
The report’s Study Date section prints February 6, 2023 as the start and end date, while this Results section prints completion on January 13, 2023. Both dates are presented as printed.
10.1 Long-wear Evaluation
At baseline and 4, 6, and 8 hours post-application, a trained technician and the subjects evaluated lipstick appearance on the lips. Individual scores appear in Appendix 2; the next page reports the summary means.
PDF page 15 — Final report, page 6 of 7: long-wear, transfer, and lip water results
10.1 Long-wear Evaluation Continued
| Timepoint | Technician mean | Subject mean |
|---|---|---|
| Baseline | 4.0 | 4.0 |
| 4 hours | 3.2 | 3.4 |
| 6 hours | 1.9 | 2.3 |
| 8 hours | 0.8 | 1.0 |
Both assessors saw decreased appearance at each later timepoint. At 4 hours, means were in the good category; at 6 hours, in or near fair; at 8 hours, in or near poor.
10.2 Transfer-proof Evaluation
| Assessment | Mean score |
|---|---|
| After rubbing | 0.4 |
The technician observed slight transfer. The mean remained near the no-evidence category after rubbing.
10.3 Water-proof Evaluation — Lips
| Assessor | Baseline | After water exposure |
|---|---|---|
| Technician | 4.0 | 4.0 |
| Subjects | 4.0 | 4.0 |
PDF page 16 — Final report, page 7 of 7: forearm water results and conclusions
10.3 Water-proof Evaluation Continued
For lips, neither assessor saw a change after splashing: 4.0 versus 4.0. All means remained in the excellent category.
| Assessor | Baseline | After water exposure |
|---|---|---|
| Technician | 4.0 | 4.0 |
| Subjects | 4.0 | 4.0 |
For forearms, neither assessor saw a change after 30-second submersion: 4.0 versus 4.0. All means remained excellent.
11.0 Conclusions
A 1-day long-wear, transfer-proof, and water-proof study of LipSense® Cream, formerly HydraMatte, was conducted with 32 female subjects.
At 4 hours, both technician and participant means remained in the good category, so the source considered a 4-hour long-wear claim supported. Scores at 6 and 8 hours were lower, as shown above.
Slight transference was observed after rubbing; under the study criterion, the source considered “transfer-proof” supported. No appearance change was observed on lips or forearms after the specified water exposure; under that protocol, the source considered “water-proof” supported.