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Evaluation of safety and efficacy of Sunekos solution injection on genital area

Evaluation of safety and efficacy of Sunekos solution injection on dryness and pruritus of the genital area due to menopause

Status
Recruiting
Phases
Phase 2
Study type
Interventional
Source
IRCT
Registry ID
IRCT20190210042676N20
Enrollment
10
Registered
2022-04-30
Start date
2022-05-22
Completion date
Unknown
Last updated
2022-05-30

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Dryness and itching of the genital area. Dryness and itching

Interventions

Intervention group: Three sessions of mesotherapy are performed in the genital area at intervals of 0.5 cm. The injection volume per session will be 2 cc and a total of 9 cc. This product includes 3ml

Sponsors

Radin Medical Idea Company
Lead Sponsor

Eligibility

Sex/Gender
Female

Inclusion criteria

Inclusion criteria: Postmenopausal women Itching and dryness in the external genital area Voluntary participation and signing written informed consent

Exclusion criteria

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

Design outcomes

Primary

MeasureTime frame
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

MeasureTime frame
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.

Countries

Iran (Islamic Republic of)

Contacts

Public ContactAniseh Samadi

Tehran University of Medical Sciences

aniseh_samadi@yahoo.com+98 21 8896 0880

Outcome results

None listed

Source: IRCT (via WHO ICTRP) · Data processed: Feb 4, 2026