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

NCT ID: NCT04219293

Last Updated: 2021-08-11

Basic Information

• Recruitment Status: TERMINATED
• Clinical Phase: NA
• Total Enrollment: 23 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2019-08-26
• Study Completion Date: 2020-02-01

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.

Conditions

Aging

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

Microneedling with NO PRP

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

Group Type: OTHER

Microneedling w/ and w/o PRP

Intervention Type: 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

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

Group Type: ACTIVE_COMPARATOR

Microneedling w/ and w/o PRP

Intervention Type: 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.

Interventions

Microneedling w/ and w/o PRP

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.

Intervention Type: DEVICE

Eligibility Criteria

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.

• Minimum Eligible Age: 30 Years
• Maximum Eligible Age: 60 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Dallas Plastic Surgery Institute

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Dallas Plastic Surgery Institute

Dallas, Texas, United States

Countries

United States

Other Identifiers

PRP01

Identifier Type: -

Identifier Source: org_study_id