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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT05694442
Other study ID # UMRAMREC002-22
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date September 1, 2022
Est. completion date March 1, 2023

Study information

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

Clinical Trial 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. 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.


Recruitment information / eligibility

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

Study Design


Related Conditions & MeSH terms


Intervention

Other:
Lipmatte K
Lipmatte K contain ingredients that may hydrate and brighten the lip

Locations

Country Name City State
Malaysia Ungku Shahrin Medical Aesthetic Research & Innovation (USMARI) Centre Petaling Jaya Selangor

Sponsors (1)

Lead Sponsor Collaborator
Ungku Shahrin Medical Aesthetic Research & Innovation (USMARI) Centre

Country where clinical trial is conducted

Malaysia, 

Outcome

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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