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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

NA

Total Enrollment

18 participants

Study Classification

INTERVENTIONAL

Study Start Date

2023-12-01

Study Completion Date

2024-12-30

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:

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.

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Detailed Description

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Conditions

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Healthy

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

OTHER

Blinding Strategy

NONE

Study Groups

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Formulation X

Participants will use the formulation once every 72 hour for 5 weeks

Group Type EXPERIMENTAL

Formulation X

Intervention Type OTHER

This formulation containing stem cell secretome and liquorice root extract

Interventions

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Formulation X

This formulation containing stem cell secretome and liquorice root extract

Intervention Type OTHER

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

Minimum Eligible Age

40 Years

Maximum Eligible Age

55 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

Yes