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

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores the safety and effectiveness of platelet-rich plasma (PRP) for treating sun-damaged skin. It compares PRP injections to saline injections, first on the arm to assess safety, then on one side of the face to evaluate effectiveness. Ideal participants are healthy individuals seeking to improve facial wrinkles and have noticeable cheek wrinkles when moving their face. Participants should not have blood disorders, recent facial surgeries, or ongoing skin conditions. As a Phase 1, Phase 2 trial, it will help researchers understand how PRP works in people and measure its effectiveness in a smaller group.

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.

Is there any evidence suggesting that platelet rich plasma is likely to be safe for humans?

Research has shown that platelet-rich plasma (PRP) is generally safe for treating various conditions. Strong evidence indicates that PRP is well-tolerated and does not cause major problems. Most side effects are mild, such as infections after treatment, but these are uncommon.

Studies have also demonstrated that PRP treatment is safe for improving skin appearance. Individuals who received PRP injections in areas like under the eyes found the process simple and almost painless. Additionally, PRP has been compared with other treatments and, in some cases, found to be safer, such as for treating frozen shoulder.

Overall, because PRP uses a person's own blood components, it is considered a safe option with a low risk of serious side effects. ^{1 2 3 4 5}

Why do researchers think this study treatment might be promising?

Unlike the standard treatments for solar elastosis, such as topical retinoids or chemical peels, Platelet Rich Plasma (PRP) is unique because it harnesses the body's own healing powers. PRP involves concentrating platelets from the patient's own blood and injecting them into the affected skin, potentially offering a more natural and regenerative approach. Researchers are excited about PRP because it directly stimulates collagen production and skin rejuvenation, which could lead to more effective and longer-lasting improvements in skin texture and elasticity compared to existing methods.

What evidence suggests that platelet rich plasma might be an effective treatment for photoaged skin?

Research has shown that platelet-rich plasma (PRP), which participants in this trial may receive, can enhance skin appearance, particularly signs of aging. Studies have found that PRP treatment reduces wrinkles and improves skin tone, especially around the eyes. PRP increases collagen and elastin, essential for maintaining skin strength and elasticity. It also improves skin texture and fullness, making the skin appear firmer and smoother. Previous findings suggest that PRP effectively supports tissue repair and renewal, which may explain its effectiveness for sun-damaged skin. In this trial, PRP will be compared to a placebo treatment using sterile saline. ^{3 6 7 8 9}

Who Is on the Research Team?

Murad Alam, MD

Principal Investigator

Northwestern University

Are You a Good Fit for This Trial?

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 for a Trial Participant

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

What Are the Treatments Tested in This Trial?

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.

How Is the Trial Designed?

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+

Published Research Related to This Trial

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]

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]

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC8182581/

Platelet-rich Plasma use for facial rejuvenation The overall pooled comparison showed that PRP treatment was significantly effective on both wrinkles and skin tone in infraorbital skin (12). Yuksel et al.

2. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC8664171/

Platelet-Rich Plasma in Aesthetics - PMC Results showed improvements in the volume, texture, and tone of facial skin and decrease both fine and deep wrinkles. To evaluate the effect of ...

3. sciencedirect.com sciencedirect.com/science/article/pii/S2589004224029328

The role of platelet-rich plasma in biomedicine This blood derivative, enriched with platelet components, has shown great potential for promoting tissue repair and regeneration.

4. cureus.com cureus.com/articles/11999-platelet-rich-plasma-for-skin-rejuvenation-and-treatment-of-actinic-elastosis-in-the-lower-eyelid-area

Platelet-rich Plasma for Skin Rejuvenation and Treatment ... In terms of the Physician's and Patient's Global Assessment, the data indicated a gradual improvement/increase in the skin volume/skin thickness ...

5. mdpi.com mdpi.com/2075-1729/14/1/40

Platelet-Rich Plasma in Dermatology: New Insights on the ... The application of PRP to aged skin has been shown to thicken the reticular dermis due to increased collagen and elastin fibre deposition. Additionally, ...

6. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC11295534/

Adverse events related to platelet-rich plasma therapy and ... PRP therapy is a relatively safe and simple treatment but may involve several AEs. •. The most commonly reported AE is postoperative infections.

7. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC10652151/

Current Status and Advancements in Platelet-Rich Plasma ... PRP is a promising conservative treatment modality for a variety of conditions with healing and regenerative capabilities and clear evidence of safety.

8. bmcmusculoskeletdisord.biomedcentral.com bmcmusculoskeletdisord.biomedcentral.com/articles/10.1186/s12891-024-07629-1

The clinical efficacy and safety of platelet-rich plasma on ... The results showed that PRP was more durable and safer than corticosteroids and other control groups in the treatment of frozen shoulder.

9. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC3565396/

Evaluation of the Effects of Platelet-Rich Plasma (PRP ... Many clinicians feel that PRP therapy is safe given its autologous nature and long-term usage without any reported major complications. For this reason in ...