NCT05694442

Brief Summary

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. 1.The hydration effect of the product on lip.
  2. 2.The brightening effect of the product on lip.
  3. 3.To observe any adverse effect occurrence with the usage of the product.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
34

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Sep 2022

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

September 1, 2022

Completed
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2022

Completed
12 days until next milestone

First Submitted

Initial submission to the registry

January 12, 2023

Completed
11 days until next milestone

First Posted

Study publicly available on registry

January 23, 2023

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2023

Completed
Last Updated

May 11, 2023

Status Verified

May 1, 2023

Enrollment Period

4 months

First QC Date

January 12, 2023

Last Update Submit

May 9, 2023

Conditions

AestheticCosmeticHealthy

Outcome Measures

Primary Outcomes (4)

  • 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

Study Arms (1)

Lipmatte K

EXPERIMENTAL

Participants will used Lipmatte K everyday for 4 weeks

Other: Lipmatte K

Interventions

Lipmatte KOTHER

Lipmatte K contain ingredients that may hydrate and brighten the lip

Lipmatte K

Eligibility Criteria

Age30 Years - 55 Years
Sexfemale(Gender-based eligibility)
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • Malaysia citizen
  • Female (age 30-55 years old)
  • Lip with mild-to-moderate dryness

You may not qualify if:

  • Subjects who have history of performing lips-related treatments such as lip augmentation (filler, botox, laser)
  • Heavy lips desquamation or chapped lip conditions

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Ungku Shahrin Medical Aesthetic Research & Innovation (USMARI) Centre

Petaling Jaya, Selangor, 47810, Malaysia

Location

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
OTHER
Intervention Model
SINGLE GROUP
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

January 12, 2023

First Posted

January 23, 2023

Study Start

September 1, 2022

Primary Completion

December 31, 2022

Study Completion

March 1, 2023

Last Updated

May 11, 2023

Record last verified: 2023-05

Data Sharing

IPD Sharing
Will not share

Locations

MY(1)