PRP for Solar Elastosis

Age: 18 - 65

Sex: Any

Trial Phase: Phase 1 & 2

Sponsor: Northwestern University

Must not be taking: Anticoagulants, Antiplatelets, Steroids, Immunosuppressants

Disqualifiers: Pregnancy, Blood disorders, Skin cancer, others

Approved in 2 Jurisdictions This treatment is already approved in other countries

Compensation: Varies

Number of Visits: 2

23 Participants Needed

Trial Summary

Will I have to stop taking my current medications?

The trial does not specify if you need to stop taking your current medications, but you cannot participate if you are on anticoagulant (blood-thinning) or antiplatelet therapy, or if you require steroids or immunosuppressive agents.

What data supports the effectiveness of the treatment Platelet Rich Plasma (PRP) for Solar Elastosis?

Research shows that PRP can help rejuvenate aging skin by promoting new collagen formation and improving skin healing, which suggests it might be effective for conditions like solar elastosis, where skin damage occurs due to sun exposure. ^{1 2 3 4 5}

Is PRP generally safe for humans?

PRP (Platelet Rich Plasma) is generally considered safe, with adverse reactions being extremely rare. It has been used in various medical fields, including dermatology and surgery, for its healing properties. ^{1 4 6 7 8}

How is the PRP treatment for solar elastosis different from other treatments?

PRP (Platelet Rich Plasma) is unique because it uses a concentration of your own blood platelets to release growth factors that help rejuvenate and repair skin, unlike other treatments that may use synthetic ingredients or chemicals. This natural approach reduces the risk of immune reactions and focuses on stimulating the body's own healing processes. ^{1 2 3 9 10}

What is the purpose of this trial?

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.

Research Team

Murad Alam, MD

Principal Investigator

Northwestern University

Eligibility Criteria

This trial is for men and women aged 35-60 who want to improve facial wrinkles. They must be in good health, understand the study, and consent to participate. Excluded are those with skin cancer history, active skin diseases or infections, immune system issues, blood disorders, recent cosmetic treatments or surgeries on the face, certain allergies like lidocaine allergy, genetic disorders affecting collagen or fibroblasts.

Inclusion Criteria

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.

Subjects of either gender (M/F), 35-60 years old.

Subjects are in good health.

Exclusion Criteria

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.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment Part 1

Safety and tolerability of platelet rich plasma injections compared to sterile saline injections in subjects' arm

6 months

Multiple visits for injections and assessments

Treatment Part 2

Effect of platelet rich plasma on facial skin in a split face study with injections on one side of the face

6 months

Multiple visits for injections and assessments

Follow-up

Participants are monitored for safety and effectiveness after treatment

12 months

Follow-up visits at 2 weeks, 3 months, 6 months, and 12 months

Treatment Details

Interventions

• Platelet Rich Plasma

Trial Overview The study tests platelet rich plasma (PRP) against sterile saline injections for treating photoaged skin. It has two parts: one checks PRP's safety on the arm; the other compares PRP's effect on one side of the face versus saline on the other over twelve months.

Participant Groups

Group I: Platelet Rich Plasma Experimental Treatment 1 Intervention

Concentrated blood platelets from subject will be injected multiple times into the superficial layer of either their arm (Part 1) or one side of their upper face and cheek (Part 2).

Group II: Sterile Saline Placebo Group 1 Intervention

Sterile saline will be injected multiple times into the superficial layer of either their arm (Part 1) or one side of their upper face and cheek (Part 2)that has not been injected with PRP.

Platelet Rich Plasma is already approved in United States, European Union for the following indications:

Approved in United States as Platelet Rich Plasma for:

• Facet-mediated lumbar low back pain
• Degenerative joint disease
• Chronic pain

Approved in European Union as Platelet Rich Plasma for:

• Orthopedic conditions
• Musculoskeletal disorders
• Pain management

Who Is Running the Clinical Trial?

Northwestern University

Lead Sponsor

Trials

1,674

Recruited

989,000+

Findings from Research

Activated platelet-rich plasma (PRP) significantly enhances the proliferation of dermal papilla (DP) cells and stimulates key signaling pathways (ERK and Akt), which are important for hair growth.

In an in vivo study with mice, injections of activated PRP led to a quicker transition from the resting phase (telogen) to the growth phase (anagen) of hair follicles compared to control mice, suggesting its potential effectiveness in promoting hair growth.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Autologous platelet-rich plasma: a potential therapeutic tool for promoting hair growth. Li, ZJ., Choi, HI., Choi, DK., et al.[2022]

Platelet-rich plasma (PRP) is derived from a patient's own blood and contains a high concentration of platelets, which can enhance tissue regeneration.

PRP has shown effectiveness in treating various types of hair loss, including androgenic alopecia and alopecia areata, expanding its use beyond orthopedic applications.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Platelet Rich Plasma for the Treatment of Scarring Alopecia Due to Discoid Lupus Erythematosus. Polster, H., Kagha, K., Luke, J.[2022]

A 41-year-old woman developed serum sickness disease (SSD) after her third platelet rich plasma (PRP) treatment for alopecia areata, highlighting a rare but serious adverse reaction to this generally safe procedure.

The case suggests that individuals with active autoimmune diseases, like alopecia areata, may face increased risks from PRP treatments, indicating that such conditions should be considered as significant contraindications.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Serum sickness disease in a patient with alopecia areata and Meniere' disease after PRP procedure. Owczarczyk-Saczonek, A., Wygonowska, E., Budkiewicz, M., et al.[2019]

Autologous plasma rich in platelets (PRP) has shown to improve gingival recession in chronic periodontitis, with a significant effect size (SMD of 0.54) based on data from four randomized controlled trials.

The efficacy of PRP in promoting complete healing of chronic skin ulcers remains inconclusive, and while adverse effects were reported, there were no significant differences between treatment groups, indicating a need for further research on its safety.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Efficacy and safety of the use of autologous plasma rich in platelets for tissue regeneration: a systematic review. Martínez-Zapata, MJ., Martí-Carvajal, A., Solà, I., et al.[2018]

References

1. Korea (South) pubmed.ncbi.nlm.nih.gov

Histologic Evidence of New Collagen Formulation Using Platelet Rich Plasma in Skin Rejuvenation: A Prospective Controlled Clinical Study. [2022]

2. Spain pubmed.ncbi.nlm.nih.gov

Application of platelet-rich plasma in the treatment of chronic skin ulcer - case report. [2021]

3. England pubmed.ncbi.nlm.nih.gov

Cervical lymphadenopathy from PRP treatment with microneedling therapy. [2019]

4. United States pubmed.ncbi.nlm.nih.gov

Autologous platelet-rich plasma: a potential therapeutic tool for promoting hair growth. [2022]

5. United States pubmed.ncbi.nlm.nih.gov

Platelet Rich Plasma for the Treatment of Scarring Alopecia Due to Discoid Lupus Erythematosus. [2022]

6. United States pubmed.ncbi.nlm.nih.gov

Serum sickness disease in a patient with alopecia areata and Meniere' disease after PRP procedure. [2019]

7. United States pubmed.ncbi.nlm.nih.gov

Efficacy and safety of the use of autologous plasma rich in platelets for tissue regeneration: a systematic review. [2018]

8. India pubmed.ncbi.nlm.nih.gov

Platelet-Rich Plasma with Microneedling in Androgenetic Alopecia: Study of Efficacy of the Treatment and the Number of Sessions Required. [2022]

9. United States pubmed.ncbi.nlm.nih.gov

The Use of Platelet-Rich Plasma in Aesthetic and Regenerative Medicine: A Comprehensive Review. [2023]

10. England pubmed.ncbi.nlm.nih.gov

History of autologous platelet-rich plasma: A short review. [2022]