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

Study Overview
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Brief Summary
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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: To assess the vagina laxity of women in Malaysia after using the formulation. To observe any adverse effect occurrence with the use of the formulation.

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

Conditions
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Healthy

Intervention / Treatment
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* Other: Formulation X


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 40 Years
Maximum Age: 55 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Other
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Formulation X<br>Participants will use the formulation once every 72 hour for 5 weeks | Other: Formulation X<br>* This formulation containing stem cell secretome and liquorice root extract<br>|

What is the study measuring?
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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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Vagina laxity