Tokyo, July 18 -- UMIN Clinical Trials Registry (UMIN-CTR) received information related to the study (UMIN000058498) titled 'Clinical Efficacy of Sunekos Therapy for the Face: A Self-Controlled Prospective Evaluation' on July 17.

Study Type: Interventional

Study Design: Basic Design - Single arm Randomization - Non-randomized Blinding - Open -no one is blinded Control - Self control

Primary Sponsor: Institute - Tokyo Chuo Beauty Clinic (TCB), BS Clinic, Umeda Osaka Ekimae Branch

Condition: Condition - Skin tissue that has atrophied or changed due to aging, trauma, congenital etc. Classification by malignancy - Others Genomic information - NO

Objective: Narrative objectives1 - This study will use a prospective survey based on patient data to examine the effectiveness of Snekos treatment on skin tissue that has atrophied or been deformed due to aging, trauma, congenital conditions, etc. Basic objectives2 - Efficacy

Intervention: Interventions/Control_1 - The injection will be administered separately to each side of the face as follows: Right side: SUNEKOS Left side: Normal saline The injection method will be water-light injection (mesotherapy), targeting the dermal layer. The total injection volume will be 3 mL.

Eligibility: Age-lower limit - 30 years-old

Gender - Male and Female Key inclusion criteria - Individuals who meet all of the following criteria: who have clear tissue deformity or atrophy due to congenital conditions, trauma, or aging. who are expected to benefit from this treatment. who wish to receive the treatment and have been deemed suitable for it by a physician. who are able to attend outpatient visits. who are adults. who have provided written informed consent for this treatment. Key exclusion criteria - who have insufficient understanding of this treatment. who lack the capacity to make an appropriate decision regarding this treatment. who do not wish to receive this treatment or for whom obtaining consent is difficult. Who are deemed unsuitable by the physician. Target Size - 10

Recruitment Status: Recruitment status - Enrolling by invitation Date of protocol fixation - 2025 Year 05 Month 01 Day Date of IRB - 2025 Year 04 Month 26 Day Anticipated trial start date - 2025 Year 05 Month 15 Day Last follow-up date - 2025 Year 07 Month 24 Day

To know more, visit https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000066869

Disclaimer: Curated by HT Syndication.