Clinical trial NCT01372566: Effect of Platelet Rich Plasma on Photoaged Skin
Official title: Effect of Autologous Platelet-rich Plasma on Photoaged Skin: A Prospective Randomized Controlled Trial (Phases A and B)
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: PHASE1
PHASE2
Conditions: Photoaging
Lead sponsor: Northwestern University
Sponsor class: OTHER
First posted: 2011-06-14
Enrollment: 23
Sex: ALL
Minimum age (years): 35
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: The goal of this study is to assess the safety, tolerability and effectiveness of platelet rich plasma in the treatment of photoaged skin. This study will be divided into two parts. The first part will assess the safety and tolerability of platelet rich plasma injections as compared to sterile saline injections in subjects' arm with six months follow-up. The second part will assess the effect of platelet rich plasma on the appearance of facial skin in a split face study with platelet rich plasma injections on one side of the face and sterile saline on the other. Outcomes will be recorded for twelve months.


Eligibility criteria: Inclusion Criteria:

Part 1:

* Subjects of either gender (M/F), 35-60 years old.
* Subjects are in good health.
* Subjects who are willing and have the ability to understand and provide informed consent for participation in the study and are able to communicate with the investigator.

Part 2:

* Subjects of either gender (M/F), 35-60 years old.
* Subjects are in good health.
* Bilateral cheek wrinkles "in motion" with severities of ≥ type II of Glogau photoaging classification (APPENDIX I).
* Subjects who are willing and have the ability to understand and provide informed consent for participation in the study and are able to communicate with the investigator.
* Subject requests cosmetic improvement of facial wrinkles.

Exclusion Criteria:

* Pregnant or lactating.
* Subjects who are unable to understand the protocol or to give informed consent.
* Subjects who have a self-reported history of blood or platelet disorders e.g. anemia, thrombocytopenia, coagulopathy, hypofibrinogenemia, or are on anticoagulant or antiplatelet therapy.
* Subjects who have active skin disease or skin infection in treatment area. Subjects who have a history of hypertrophic scars and keloids.
* Subjects who have any requirement for the use of local or systemic steroids or immunosuppressive agents.
* Subject notes that he/she is HIV positive
* Subjects with history of skin cancer or actinic keratosis
* Uncooperative patients or patients with neurological disorders who are incapable of following directions or who are predictably unwilling to return for follow-up examinations.
* Skin conditions that interfere with wrinkle assessment/treatment (excessive dermatochalasis, inability to lessen the wrinkles by physically spreading the area apart).
* Excessive exposure to the sun, such as jobs requiring constant outdoor exposure.
* Known genetic disorders affecting fibroblasts or collagen, such as achondroplasia, osteogenesis imperfecta, ect.

Part 2:

* Pregnant or lactating.
* Subjects who are unable to understand the protocol or to give informed consent.
* Subjects who have a history of blood or platelet disorders e.g. anemia, thrombocytopenia, coagulopathy, hypofibrinogenemia, or are on anticoagulant or anti-platelet therapy.
* Subjects who have had topical or oral tretinoin, chemical peeling, botulinum toxin injection or laser and light treatment for facial rhytides or rejuvenation within past 6 months or planning to undergo treatments as described in the next 3 months.
* Facial surgery in the lower 2/3 of the face or semi-permanent dermal fillers within 1 year prior to study enrollment
* Subjects who have history of recurrent facial or labial herpes simplex infection.
* Subjects who have active skin disease or skin infection in treatment area.
* Subjects who are allergic to lidocaine or prilocaine.
* Subjects who have a history of hypertrophic scars and keloids.
* Subjects who have any requirement for the use of local or systemic steroids or immunosuppressive agents.
* Subject notes that he/she is HIV positive
* Subjects with history of skin cancer or actinic keratosis
* Uncooperative patients or patients with neurological disorders who are incapable of following directions or who are predictably unwilling to return for follow-up examinations.
* Skin conditions that interfere with wrinkle assessment/treatment (excessive dermatochalasis, inability to lessen the wrinkles by physically spreading the area apart).
* Excessive exposure to the sun, such as jobs requiring constant outdoor exposure.
* Known genetic disorders affecting fibroblasts or collagen, such as achondroplasia, osteogenesis imperfecta, ect.

Primary outcomes:
measure: Primary Outcome Study Part 1: Safety and Tolerability
timeFrame: 2 weeks, 1 month, 3 months and 6 months
measure: Primary Outcome Study Part 2: Change in Photoaging scores from Baseline at 2 weeks, 3 months, and 6 months
timeFrame: Treatment visit, 2 weeks, 3 months and 6 months
Secondary outcomes:
measure: Secondary Outcome of Study Part 1: Histologic analysis
timeFrame: 1 month
measure: Secondary Outcome Study Part 2: Self-Assessment
timeFrame: 3 and 6 months
measure: Secondary Outcome Study Part 2: Subject Satisfaction
timeFrame: 6 months
measure: Secondary Outcome Study Part 2: Rate of Adverse Events
timeFrame: 2 weeks, 3 months, 6 months, 12 months
Other outcomes:
Locations:
city: Chicago
country: United States
facility: Northwestern University Dermatology
state: Illinois
Study officials:
affiliation: Northwestern University
name: Murad Alam, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Alam M, Hughart R, Champlain A, Geisler A, Paghdal K, Whiting D, Hammel JA, Maisel A, Rapcan MJ, West DP, Poon E. Effect of Platelet-Rich Plasma Injection for Rejuvenation of Photoaged Facial Skin: A Randomized Clinical Trial. JAMA Dermatol. 2018 Dec 1;154(12):1447-1452. doi: 10.1001/jamadermatol.2018.3977.