Healthy Clinical Trial
Official title:
The Effect of Lipmatte K on Lip Hydration and Brightening
| Verified date | May 2023 |
| Source | Ungku Shahrin Medical Aesthetic Research & Innovation (USMARI) Centre |
| Contact | n/a |
| Is FDA regulated | No |
| Health authority | |
| Study type | Interventional |
This study is conducted to evaluate the safety and the effectiveness of Lipmatte K on lip hydration and brightening. The study duration is 4 weeks and the lip assessment will be carried out at baseline, week 2 and week 4.The main questions this study aims to answer are: 1. The hydration effect of the product on lip. 2. The brightening effect of the product on lip. 3. To observe any adverse effect occurrence with the usage of the product.
| Status | Completed |
| Enrollment | 34 |
| Est. completion date | March 1, 2023 |
| Est. primary completion date | December 31, 2022 |
| Accepts healthy volunteers | Accepts Healthy Volunteers |
| Gender | Female |
| Age group | 30 Years to 55 Years |
| Eligibility | Inclusion Criteria: - Malaysia citizen - Female (age 30-55 years old) - Lip with mild-to-moderate dryness Exclusion Criteria: - Subjects who have history of performing lips-related treatments such as lip augmentation (filler, botox, laser) - Heavy lips desquamation or chapped lip conditions |
| Country | Name | City | State |
|---|---|---|---|
| Malaysia | Ungku Shahrin Medical Aesthetic Research & Innovation (USMARI) Centre | Petaling Jaya | Selangor |
| Lead Sponsor | Collaborator |
|---|---|
| Ungku Shahrin Medical Aesthetic Research & Innovation (USMARI) Centre |
Malaysia,
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | Change in lip roughness from baseline and at week 2 and 4 after using Lipmatte K | Degree of lip roughness for each participant's will be determined by dermatologist based on score 0 to 2 (0= no desquamations, 1 = slight desquamations and 2 = heavy desquamations) | Baseline, Week 2, Week 4 | |
| Primary | Change in lip wrinkles from baseline and at week 2 and 4 after using Lipmatte K | Degree of lip wrinkle for each participant's will be determined by dermatologist based on score 0- 2 (0 = no/almost no vertical wrinkles, 1 = no deep vertical wrinkles and 2 = many deep vertical wrinkles) | Baseline, Week 2, Week 4 | |
| Primary | Visual assessment of the lip from baseline and at week 2 and 4 after using Lipmatte K | Image of the lip will be captured using digital camera (Nikon D5100) to observed the brightening effect of the lipmatte | Baseline, Week 2, Week 4 | |
| Primary | Adverse effect after using Lipmatte K | Based on adverse effect occurrence on participants that occur during study period (4 weeks) | Week 4 |
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