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

NCT04219293 | Terminated FDA Device

• 1 other identifier: PRP01
• Study Type: interventional
• Target: 23
• Locations: 1 country
• Sites: 1

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.

Conditions

Aging

Outcome Measures

Primary Outcomes (4)

• Overall Skin improvement assessed by a Visia Scan.

  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.

  6 months

• Overall Patient satisfaction of skin improvement assessed by the Global Aesthetic Improvement Scale.

  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.

  6 months

• Overall Patient satisfaction of skin improvement assessed by the Face-Q Aesthetic Satisfaction with Outcome.

  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.

  6 months

• Overall Patient satisfaction of skin improvement assessed by the Face-Q Aesthetic Satisfaction with Skin.

  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.

  6 months

Study Arms (2)

Microneedling with NO PRP

OTHER

Patient will receive Standard of Care micro needling on randomized side of the face.

Device: Microneedling w/ and w/o PRP

Microneedling WITH PRP

ACTIVE COMPARATOR

Patient will receive Standard of care microneedling with PRP on randomized side of the face.

Device: Microneedling w/ and w/o PRP

Interventions

Microneedling w/ and w/o PRP DEVICE

i. Split face comparison. Vertical line drawn midline nose extending upwards to hairline and downwards to jawline separating face into two equal treatment areas. The patients determined side of face will be treated with SkinPen Microneedling and PRP the other (nondetermined from randomization) will be treated with SkinPen Microneedling and glide. The patient side of face that will not use PRP will be treated first. The following settings will be used as treatment protocol. Topical anesthetic Benzocaine 20%, Lidocaine 10%, and Tetracaine 10% will be applied covering entire treatment area. The anesthetic will remain on skin for 30 minutes.

Microneedling WITH PRP; Microneedling with NO PRP

Eligibility Criteria

• Age: 30 Years - 60 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Dallas Plastic Surgery Institute: lead

Study Sites (1)

Dallas Plastic Surgery Institute

Dallas, Texas, 75231, United States

Location

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 9, 2019
• First Posted: January 7, 2020
• Study Start: August 26, 2019
• Primary Completion: January 1, 2020
• Study Completion: February 1, 2020
• Last Updated: August 11, 2021

Record last verified: 2021-08

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)