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

Ungku Shahrin Medical Aesthetic Research & Innovation (USMARI) Centre

Status: Enrolling

Conditions: Healthy

Treatments: Other: Formulation X

Study type: Interventional

Funder types: Industry

Identifiers

NCT05710536

UMRAMREC006-22

Details and patient eligibility

About

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.

Enrollment: 18 estimated patients

Sex: Female

Ages: 40 to 55 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Other

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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18 participants in 1 patient group

Formulation X

Experimental group

Description:

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

Treatment:

Other: Formulation X