Evaluation of safety and efficacy of Sunekos solution injection on genital area
Phase 2
Recruiting
- Conditions
- Dryness and itching of the genital area.Dryness and itching
- Registration Number
- IRCT20190210042676N20
- Lead Sponsor
- Radin Medical Idea Company
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Recruiting
- Sex
- Female
- Target Recruitment
- 10
Inclusion Criteria
Postmenopausal women
Itching and dryness in the external genital area
Voluntary participation and signing written informed consent
Exclusion Criteria
Active infection in the area include HPV, etc.
Systemic diseases including diabetes and malignancies
History of treatments related to darkness of the region such as laser, local lightening products and PRP in the past 6 months
Study & Design
- Study Type
- interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Apparent changes in dryness and itching of genital area. Timepoint: Before intervention, 2 weeks and three months after third session of injection. Method of measurement: Comparing before-after photos, based on the following criteria: 0= no improvement(0–25%), 1= fair improvement(25–49%), 2= good improvement(50–74%) and 3= excellent improvement(>75%).
- Secondary Outcome Measures
Name Time Method Changes in skin elasticity. Timepoint: Before intervention ,2 weeks and three months after third session of injection. Method of measurement: Cutometery performed by related probes of MPA580 device.;Changes in skin hydration in the genital area. Timepoint: Before intervention ,2 weeks and three months after third session of injection. Method of measurement: Corneometry performed by related probes of MPA580 device.