Split Face Study of the Effects of Micro Needling With and Without Platelet Rich Plasma

Not Applicable

Terminated

• Conditions: Aging
• Interventions: Device: Microneedling w/ and w/o PRP

• Registration Number: NCT04219293
• Lead Sponsor: Dallas Plastic Surgery Institute

Brief Summary

This pilot study will expand knowledge and application of 2 X concentration of Platelet Rich Plasma (PRP) in conjunction with microneedling using the SkinPen device.

Detailed Description

There have been numerous studies demonstrating benefits of microneedling. However, to date there is no published research expanding on the benefits of using platelet rich plasma in conjunction with microneedling for facial aesthetics. This pilot study will expand knowledge and application of 2 X concentration of Platelet Rich Plasma (PRP) in conjunction with microneedling using the SkinPen device. The pilot aims to objectively measure skin quality using the Visia systemTM and provide objective data to compare Microneedling with the use of (PRP) versus microneedling without the use of PRP. The pilot also aims to subjectively measure skin improvement using the Face QTM and the Global Aesthetic Improvement ScaleTM.

Study Timeline

• Study Start: 2019-08-26
• Study First Submitted: 2019-12-09
• Primary Completion: 2020-01-01
• Study First Submitted QC: 2020-01-03
• Study First Posted: 2020-01-07
• Study Completion: 2020-02-01
• Status Verified: 2021-08
• Last Update Submitted: 2021-08-04
• Last Update Posted: 2021-08-11

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 23

Inclusion Criteria

• Healthy males and females ages 30-60 years old.
• No previous minimally invasive or invasive skin resurfacing within the prior 12 months (i.e. fractionated laser, ablated laser, chemical peels, microneedling, etc...
• VisiaTM Scan showing aging including skin texture, wrinkles, brown spots, and pores.
• Patient willing to sign informed consent.

Exclusion Criteria

• Keloid scars;
• History of eczema in treatment area; psoriasis and any other chronic skin conditions the Investigator determines disqualifies the patient for participation in treatment area;
• History of actinic (solar) keratosis in treatment area;
• History of hemophilia;
• History of diabetes;
• The presence of raised moles, warts on the targeted area.
• Absolute contraindications include; scleroderma, collagen vascular diseases or cardiac abnormalities; blood clotting problems; active bacterial or fungal infection; facial melanosis; malignant tumors, immunosuppression; use of blood thinners or prednisone; pregnant or nursing women; corticosteroids within two weeks of the procedure, chronic liver disease, porphyria or other skin diseases.
• Patient not willing to sign informed consent.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Microneedling with NO PRP	Microneedling w/ and w/o PRP	Patient will receive Standard of Care micro needling on randomized side of the face.
Microneedling WITH PRP	Microneedling w/ and w/o PRP	Patient will receive Standard of care microneedling with PRP on randomized side of the face.

Primary Outcome Measures

Name	Time	Method
Overall Patient satisfaction of skin improvement assessed by the Face-Q Aesthetic Satisfaction with Skin.	6 months	The FACE-Q© is a patient-reported outcome (PRO) measure that can be used to measure outcomes of. aesthetic facial procedures and products from the patient's perspective.
Overall Patient satisfaction of skin improvement assessed by the Global Aesthetic Improvement Scale.	6 months	The Global Aesthetic Improvement Scale (GAIS) is a 5-point scale rating global aesthetic improvement in appearance, compared to pretreatment, as judged by the investigator.
Overall Patient satisfaction of skin improvement assessed by the Face-Q Aesthetic Satisfaction with Outcome.	6 months	The FACE-Q© is a patient-reported outcome (PRO) measure that can be used to measure outcomes of. aesthetic facial procedures and products from the patient's perspective.
Overall Skin improvement assessed by a Visia Scan.	6 months	The VISIA® facial scan uses 3-D imaging to accurately identify and quantify all aesthetic skin concerns, even before there are visible signs of damage or aging. Using a state-of-the-art, multi-point positioning system the visia scanner captures multiple angles of your skin.

Trial Locations

Locations (1)

Dallas Plastic Surgery Institute; 🇺🇸 Dallas, Texas, United States