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

Safety and Efficacy of Formulation Containing Stem Cell Secretome and Liquorice Root Extract for Improving Vagina Laxity of Women in Malaysia: A Pilot Study.

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 Overview

• Status: Terminated
• Conditions: Healthy
• Intervention / Treatment: Other: Formulation X

• Study Type: Interventional
• Enrollment (Actual): 18
• 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: 40 years to 55 years (Adult)
• Accepts Healthy Volunteers: Yes

Description

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

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: Formulation X; Participants will use the formulation once every 72 hour for 5 weeks	Other: Formulation X; This formulation containing stem cell secretome and liquorice root extract

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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)	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.	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)	week 5

Collaborators and Investigators

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

Study record dates

Study Major Dates

• Study Start (Actual): December 1, 2023
• Primary Completion (Actual): October 31, 2024
• Study Completion (Actual): December 30, 2024

Study Registration Dates

• First Submitted: January 13, 2023
• First Submitted That Met QC Criteria: January 24, 2023
• First Posted (Actual): February 2, 2023

Study Record Updates

• Last Update Posted (Actual): March 6, 2026
• Last Update Submitted That Met QC Criteria: March 4, 2026
• Last Verified: March 1, 2026

More Information

Terms related to this study

• Keywords: Vagina laxity
• Other Study ID Numbers: UMRAMREC006-22

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