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

NCT05710536 | Terminated

• 1 other identifier: UMRAMREC006-22
• Study Type: interventional
• Target: 18
• Locations: 1 country
• Sites: 1

Brief Summary

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. 1.To assess the vagina laxity of women in Malaysia after using the formulation.
2. 2.To observe any adverse effect occurrence with the use of the formulation.

Conditions

Healthy

Keywords

Vagina laxity

Outcome Measures

Primary Outcomes (3)

• 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

Study Arms (1)

Formulation X

EXPERIMENTAL

Participants will use the formulation once every 72 hour for 5 weeks

Other: Formulation X

Interventions

Formulation X OTHER

This formulation containing stem cell secretome and liquorice root extract

Formulation X

Eligibility Criteria

• Age: 40 Years - 55 Years
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• Malaysian women ( age 40 to 55 years old)
• Complaint of vagina laxity
• Willingness to participate in the study

You may not qualify if:

• 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

Sponsors & Collaborators

• USMARI Research & Innovation Centre: lead

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 13, 2023
• First Posted: February 2, 2023
• Study Start: December 1, 2023
• Primary Completion: October 31, 2024
• Study Completion: December 30, 2024
• Last Updated: March 6, 2026

Record last verified: 2026-03

Data Sharing

• IPD Sharing: Will not share

Locations

MY (1)