Safety and Efficacy of Formulation for Improving Vagina Laxity
Study Details
Study Description
Brief Summary
This study is conducted to investigate the safety and efficacy of the formulation containing stem cell secretome, cobrotoxin (CTX) peptides, Sophora Flavescens root extract 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:
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To assess the vagina laxity of women in Malaysia after using the formulation.
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To observe any adverse effect occurrence with the use of the formulation.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
N/A |
Study Design
Arms and Interventions
| 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, CTX peptides,lLiquorice root and Sophora Flavescens root extract
|
Outcome Measures
Primary Outcome Measures
- Change in vagina laxity condition from baseline and at week 2 and week 5 after using the product [Baseline, Week 2 and Week 5]
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)
- Change in vagina tone from baseline and at week 2 and week 5 after using the product [Baseline, Week 2 and Week 5]
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.
- Adverse effect after using the formulation [week 5]
Based on adverse effect occurrence on participants that occur during study period (5 weeks)
Eligibility Criteria
Criteria
Inclusion Criteria:
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Malaysian women ( age 40 to 55 years old)
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Complaint of vagina laxity
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Willingness to participate in the study
Exclusion Criteria:
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Pregnant and breastfeeding women
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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
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Presence of illness or taking any medication that might impact the study outcome or participants well-being
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Ungku Shahrin Medical Aesthetic Research & Innovation (USMARI) Centre | Petaling Jaya | Selangor | Malaysia | 47810 |
Sponsors and Collaborators
- Ungku Shahrin Medical Aesthetic Research & Innovation (USMARI) Centre
Investigators
None specified.Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- UMRAMREC006-22