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

Healthy Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05710536
• Other study ID #: UMRAMREC006-22
• Status: Recruiting
• Phase: N/A
• Start date: December 1, 2023
• Est. completion date: December 30, 2024

Study information

• Verified date: November 2023
• Source: Ungku Shahrin Medical Aesthetic Research & Innovation (USMARI) Centre
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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. 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 18
• Est. completion date: December 30, 2024
• Est. primary completion date: October 31, 2024
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 40 Years to 55 Years

Eligibility

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

Related Conditions & MeSH terms

• Healthy

Intervention

Other:
• Formulation X
This formulation containing stem cell secretome and liquorice root extract

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 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
Primary	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
Primary	Adverse effect after using the formulation	Based on adverse effect occurrence on participants that occur during study period (5 weeks)	week 5