Tokyo, July 10 -- UMIN Clinical Trials Registry (UMIN-CTR) received information related to the study (UMIN000058413) titled 'Clinical Efficacy of PRP Therapy for the Face: A Self-Controlled Prospective Evaluation' on July 9.
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 PRP treatment on skin tissue that has atrophied or been deformed due to aging, trauma, congenital conditions, etc.
Basic objectives2 - Efficacy
Intervention:
Interventions/Control_1 - PRP is prepared using the patient's own blood as the source material.
The prepared PRP is then administered to the patient's face.
Injection is performed on both the right and left sides of the face as follows:
Right side: PRP
Left side: Normal saline
The injections are performed using a mesotherapy device, with the target depth being the dermal layer.
The volume of PRP administered ranges from 1 to 6 mL, depending on the size and condition of the treated area.
Eligibility:
Age-lower limit - 18
years-old
<=
Age-upper limit - Not applicable
Gender - Male and Female
Key inclusion criteria - Individuals who meet all of the following criteria
Have clear tissue deformity or atrophy due to congenital conditions, trauma, or aging
Are expected to benefit from this treatment
Wish to receive the treatment and have been deemed suitable for it by a physician
Are able to attend outpatient visits
adults
Have provided written informed consent for this treatment
Key exclusion criteria - Have a clearly apparent infection in the area surrounding the injection site
Have a predisposition to keloid formation
Have an insufficient understanding of this treatment
Lack the capacity to make an informed decision regarding this treatment
Do not wish to receive this treatment or are unable to provide informed consent
Are deemed inappropriate for the treatment by the physician, such as those with malignant tumors, infectious tumors, infectious diseases, or inflammatory diseases
Target Size - 10
Recruitment Status:
Recruitment status - Enrolling by invitation
Date of protocol fixation - 2025 Year 04 Month 01 Day
Date of IRB - 2025 Year 03 Month 29 Day
Anticipated trial start date - 2025 Year 04 Month 15 Day
Last follow-up date - 2025 Year 10 Month 31 Day
To know more, visit https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000066783
Disclaimer: Curated by HT Syndication.