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

D

Dallas Plastic Surgery Institute

Status

Terminated

Conditions

Aging

Treatments

Device: Microneedling w/ and w/o PRP

Study type

Interventional

Funder types

Other

Identifiers

Details and patient eligibility

About

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.

Full 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.

Enrollment

23 patients

Sex

All

Ages

30 to 60 years old

Volunteers

Accepts Healthy Volunteers

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.

Trial design

Primary purpose

Treatment

Allocation

Non-Randomized

Interventional model

Single Group Assignment

Masking

Single Blind

23 participants in 2 patient groups

Microneedling with NO PRP
Other group
Description:
Patient will receive Standard of Care micro needling on randomized side of the face.
Treatment:
Device: Microneedling w/ and w/o PRP
Microneedling WITH PRP
Active Comparator group
Description:
Patient will receive Standard of care microneedling with PRP on randomized side of the face.
Treatment:
Device: Microneedling w/ and w/o PRP

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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