Clinical trial NCT04219293: Split Face Study of the Effects of Micro Needling With and Without Platelet Rich Plasma
Official title: A Single-center, Randomized, Split Face Study of the Effects of Micro Needling With Platelet Rich Plasma Compared to Microneedling Without Platelet Rich Plasma
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: NA
Conditions: Aging
Lead sponsor: Dallas Plastic Surgery Institute
Sponsor class: OTHER
First posted: 2020-01-07
Enrollment: 23
Sex: ALL
Minimum age (years): 30
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.

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.

Primary outcomes:
measure: Overall Skin improvement assessed by a Visia Scan.
timeFrame: 6 months
measure: Overall Patient satisfaction of skin improvement assessed by the Global Aesthetic Improvement Scale.
timeFrame: 6 months
measure: Overall Patient satisfaction of skin improvement assessed by the Face-Q Aesthetic Satisfaction with Outcome.
timeFrame: 6 months
measure: Overall Patient satisfaction of skin improvement assessed by the Face-Q Aesthetic Satisfaction with Skin.
timeFrame: 6 months
Secondary outcomes:
Other outcomes:
Locations:
city: Dallas
country: United States
facility: Dallas Plastic Surgery Institute
state: Texas
Study officials:
References: