Safety and Efficacy of Formulation for Improving Vagina Laxity: A Pilot Study

Ungku Shahrin Medical Aesthetic Research & Innovation (USMARI) Centre18 enrolled

Overview

This study is conducted to investigate the safety and efficacy of the formulation containing stem cell secretome and licorice root extract in improving vagina laxity (VL) condition of women in Malaysia. This formulation may stimulate cell rejuvenation and trigger cell renewal efficiently as they contained rich mixture of natural, bioavailable polypeptides and plant extracts and these might help improving the VL condition in women. The study duration is 5 weeks and vagina assessment will be carried out at baseline, week 2 and week 5.The main objectives of this study are: 1. To assess the vagina laxity of women in Malaysia after using the formulation. 2. To observe any adverse effect occurrence with the use of the formulation.

Study Type

INTERVENTIONAL

Allocation

Purpose

OTHER

Masking

NONE

Enrollment

Conditions

Healthy

Interventions

Eligibility

Sex: FEMALEMin age: 40 YearsMax age: 55 YearsHealthy volunteers:

Medical Language ↔ Plain English

Inclusion Criteria: * Malaysian women ( age 40 to 55 years old) * Complaint of vagina laxity * Willingness to participate in the study Exclusion Criteria: * Pregnant and breastfeeding women * Doing any surgical or non-surgical procedures to improved vaginal laxity condition such as laser and radiofrequency before participating in the study that might affect the study outcome * Presence of illness or taking any medication that might impact the study outcome or participants well-being

Outcomes

Primary Outcomes

Change in vagina laxity condition from baseline and at week 2 and week 5 after using the product

Vagina laxity questionnaire (VLQ) will be used to assess participant's vagina laxity conditions at baseline, week 2 and week 5. This is a self-reported tool where participants will be asking to score their vagina laxity on a scale of 1 to 7 (1= very loose, 2= moderately loose, 3= slightly loose, 4= neither tight nor loose, 5= very tight, 6= moderately tight, 7= very tight)

Time frame: Baseline, Week 2 and Week 5

Change in vagina tone from baseline and at week 2 and week 5 after using the product

Vagina tone is measured using a perineometer (measurement of vaginal squeeze pressure). This assessment will be carried out by trained clinician at baseline, week 2 and week 5 and it will determine participant vagina tone.

Time frame: Baseline, Week 2 and Week 5

Adverse effect after using the formulation

Based on adverse effect occurrence on participants that occur during study period (5 weeks)

Time frame: week 5