The Effect of Lipmatte K

The Effect of Lipmatte K on Lip Hydration and Brightening

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.

Study Overview

• Status: Completed
• Conditions: Healthy; Aesthetic; Cosmetic
• Intervention / Treatment: Other: Lipmatte K

• Study Type: Interventional
• Enrollment (Actual): 34
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Malaysia
  • Selangor
    • Petaling Jaya, Selangor, Malaysia, 47810
      • Ungku Shahrin Medical Aesthetic Research & Innovation (USMARI) Centre

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 30 years to 55 years (Adult)
• Accepts Healthy Volunteers: Yes

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Other
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Lipmatte K; Participants will used Lipmatte K everyday for 4 weeks	Other: Lipmatte K; Lipmatte K contain ingredients that may hydrate and brighten the lip

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
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
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
Adverse effect after using Lipmatte K	Based on adverse effect occurrence on participants that occur during study period (4 weeks)	Week 4

Collaborators and Investigators

• Sponsor: Ungku Shahrin Medical Aesthetic Research & Innovation (USMARI) Centre

Study record dates

Study Major Dates

• Study Start (Actual): September 1, 2022
• Primary Completion (Actual): December 31, 2022
• Study Completion (Actual): March 1, 2023

Study Registration Dates

• First Submitted: January 12, 2023
• First Submitted That Met QC Criteria: January 12, 2023
• First Posted (Actual): January 23, 2023

Study Record Updates

• Last Update Posted (Estimate): May 11, 2023
• Last Update Submitted That Met QC Criteria: May 9, 2023
• Last Verified: May 1, 2023

More Information

Terms related to this study

• Other Study ID Numbers: UMRAMREC002-22

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No