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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:
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Formulation X | Experimental | Participants will use the formulation once every 72 hour for 5 weeks |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Formulation X | Other | This formulation containing stem cell secretome and liquorice root extract |
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| 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 |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Ungku Shahrin Medical Aesthetic Research & Innovation (USMARI) Centre | Petaling Jaya | Selangor | 47810 | Malaysia |
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