Healthy
Conditions
Keywords
Vagina laxity
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. 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.
Interventions
OTHERFormulation X
This formulation containing stem cell secretome and liquorice root extract
Sponsors
Ungku Shahrin Medical Aesthetic Research & Innovation (USMARI) Centre
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
OTHER
Masking
NONE
Eligibility
Sex/Gender
FEMALE
Age
40 Years to 55 Years
Healthy volunteers
Yes
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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) |
Countries
Malaysia
Outcome results
None listed