Microneedling for Burn Scars
Recruiting in Palo Alto (17 mi)
Age: Any Age
Sex: Any
Travel: May Be Covered
Time Reimbursement: Varies
Trial Phase: Academic
Recruiting
Sponsor: Centre hospitalier de l'Université de Montréal (CHUM)
Must not be taking: Anticoagulants
Disqualifiers: Keloid scars, Psychiatric condition, others
No Placebo Group
Approved in 3 Jurisdictions
Trial Summary
What is the purpose of this trial?Approximately 33 to 91% of severe burn victims will develop hypertrophic scars. Hypertrophic scars are defined as erythematous (red), raised and rigid scars that can cause pain and itching, among other things. They cause psychological distress and affect the quality of life of burn victims. Microneedling is a technique that uses an electrical device to create hundreds of microchannels that penetrate the skin layers. This study is interested in determining the effectiveness of microneedling in improving the pliability, thickness and erythema of hypertrophic scars. Each scar will receive up to 5 ACS-pen treatments followed by the application of cortisone (triamcinolone acetonide). Knowing that microneedling increases the absorption of products applied to the skin by about 80%, it is logical to think that creating these channels to the dermis and applying cortisone afterwards would have a beneficial effect on the hypertrophic scars of these patients.
Do I need to stop my current medications for the trial?
The trial does not specify if you need to stop taking your current medications, but you cannot participate if you are on anticoagulant medications (blood thinners).
What data supports the effectiveness of the treatment Microneedling for burn scars?
Research shows that microneedling, which involves creating tiny injuries in the skin to stimulate healing, can improve the appearance of various types of scars, including burn scars. It works by activating growth factors and increasing collagen production, which helps remodel the scar tissue.
12345Is microneedling safe for treating burn scars?
Microneedling is generally considered safe for various skin conditions, including burn scars, with mild and temporary side effects like skin discoloration and rare allergic reactions.
24678How is microneedling treatment for burn scars different from other treatments?
Microneedling is unique because it uses tiny needles to create micro-injuries in the skin, which triggers the body's natural healing process, leading to increased collagen production and improved scar appearance. This minimally invasive approach offers a way to remodel scars with minimal downtime compared to more invasive procedures.
234910Eligibility Criteria
This trial is for individuals aged 16 or older with at least two hypertrophic scars from burns, who can consent to treatment. It's not suitable for those with keloid scars, mature scar sites, certain psychiatric or cognitive impairments, skin conditions like psoriasis or eczema near the scar site, allergies to ultrasound gel, language barriers in English or French, or those on anticoagulants.Inclusion Criteria
I am 16 years old or older.
My gender or race does not limit my participation.
Have at least 2 HSc that meet the clinical criteria for HSc
+1 more
Exclusion Criteria
I cannot understand English or French.
My surgical scar has fully healed.
I am currently taking blood thinner medications.
+4 more
Trial Timeline
Screening
Participants are screened for eligibility to participate in the trial
2-4 weeks
Treatment
Participants receive microneedling treatments every six weeks for a maximum of five treatments, followed by the application of cortisone
30 weeks
5 visits (in-person)
Follow-up
Participants are monitored for changes in skin elasticity, thickness, and erythema after treatment
12 weeks
2 visits (in-person)
Participant Groups
The study tests microneedling's effectiveness on burn-related hypertrophic scars. Microneedling involves an electrical device creating microchannels in the skin followed by cortisone application. The goal is to improve scar pliability, thickness and redness through up to five treatments.
2Treatment groups
Experimental Treatment
Active Control
Group I: Microneedling treated scarExperimental Treatment1 Intervention
Microneedling
Group II: Control scarActive Control1 Intervention
No intervention, standard of care
Microneedling is already approved in United States, European Union, Canada for the following indications:
🇺🇸 Approved in United States as Microneedling for:
- Facial rejuvenation
- Acne scars
- Burn scars
- Hypertrophic scars
🇪🇺 Approved in European Union as Microneedling for:
- Skin rejuvenation
- Scars
- Burn scars
- Hypertrophic scars
🇨🇦 Approved in Canada as Microneedling for:
- Cosmetic skin treatments
- Scars
- Burn scars
Find a Clinic Near You
Research Locations NearbySelect from list below to view details:
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Who Is Running the Clinical Trial?
Centre hospitalier de l'Université de Montréal (CHUM)Lead Sponsor
References
Percutaneous collagen induction therapy: an alternative treatment for burn scars. [2022]This study aims to evaluate percutaneous collagen induction (PCI) in post-burn scarring.
Microneedling Outcomes in Early Postsurgical Scars. [2022]Scars are a vexing sequela of surgery. Microneedling, also known as minimally invasive percutaneous collagen induction, has demonstrated impressive improvements in chronic acne scars; however, no evidence exists for treating postsurgical scars during active wound healing. The purpose of this study was to demonstrate the utility and safe use of minimally invasive percutaneous collagen induction in acute postsurgical scars.
Multiple microneedling sessions for minimally invasive facial rejuvenation: an objective assessment. [2015]Microneedling or percutaneous collagen induction is a new modality used for skin rejuvenation, tightening, and scar remodeling. It offers a simple and effective treatment for photoaged skin with minimal disruption of the epidermis, thus limiting adverse effects and minimizing downtime.
MICRONEEDLING - A FORM OF COLLAGEN INDUCTION THERAPY - OUR FIRST EXPERIENCES. [2019]Microneedling (percutaneous collagen induction therapy) is a new promising miniinvasive therapeutic method for the treatment of skin alterations of different aetiology, including burn scars. Since 2016, it is also available at our department. The microtraumatization of scars with the Dermaroller® leads to an activation of the healing cascade, activation of growth factors, which activate cell proliferation in the wound, increased synthesis and deposit of collagen - elastin complex with successive transformation of collagen III to collagen I, to neoangiogenesis and thus to accelerated scar remodelling.
Microneedling of Scars: A Large Prospective Study with Long-Term Follow-Up. [2021]In recent years, microneedling has been increasingly used to treat a number of dermatologic conditions, including scars. Although initial studies demonstrated improvement of (mostly) atrophic scars with microneedling, the number of patients evaluated was relatively small, and the devices and treatment protocols used and posttreatment follow-up varied widely. Through this prospective observational study, the results of microneedling on 120 patients with a variety of scars are described.
Dermatotoxicology of microneedles (MNs) in man. [2020]Developed within the last few decades, microneedles (MNs) have only recently seen wide-scale use among the general population, especially in the area of cosmetics. With the FDA only starting to regulate microneedling devices and the many new microneedling products that enter the modern global market, it is of utmost importance to establish the safety profile and reasonable expectations of the microneedling practice and its products. In our review of current literature, the authors searched the keyword "microneedle" with the following terms: "safety", "side effect", "toxicology", "adverse effect", "adverse event", "infection", "dermatitis", "granuloma", "scarring", and "hyperpigmentation". Despite wide-scale implementation of MNs, we are likely only beginning to understand the potential of MNs as a medical and consumer product, and we should, therefore, be aware of any potential adverse events associated with the product.
Microneedling: A Comprehensive Review. [2017]Microneedling is a minimally invasive procedure that uses fine needles to puncture the epidermis. The microwounds created stimulate the release of growth factors and induce collagen production. The epidermis remains relatively intact, therefore helping to limit adverse events. The indications for microneedling therapy have grown significantly, and it is becoming a more widely used treatment in dermatology.
Microneedling in All Skin Types: A Review. [2017]INTRODUCTION: Microneedling procedures are growing in popularity for a wide variety of skin conditions. This paper comprehensively reviews the medical literature regarding skin needling efficacy and safety in all skin types and in multiple dermatologic conditions. METHODS: A PubMed literature search was conducted in all languages without restriction and bibliographies of relevant articles reviewed. Search terms included: "microneedling," "percutaneous collagen induction," "needling," "skin needling," and "dermaroller." RESULTS: Microneedling is most commonly used for acne scars and cosmetic rejuvenation, however, treatment benefit has also been seen in varicella scars, burn scars, keloids, acne, alopecia, and periorbital melanosis, and has improved flap and graft survival, and enhanced transdermal delivery of topical products. Side effects were mild and self-limited, with few reports of post-inflammatory hyperpigmentation, and isolated reports of tram tracking, facial allergic granuloma, and systemic hypersensitivity. DISCUSS: Microneedling represents a safe, cost-effective, and efficacious treatment option for a variety of dermatologic conditions in all skin types. More double-blinded, randomized, controlled trials are required to make more definitive conclusions. J Drugs Dermatol. 2017;16(4):308-314..
Microneedling: A Review and Practical Guide. [2018]Microneedling is a relatively new treatment option in dermatology and has been touted for a broad range of applications including skin rejuvenation, acne scarring, rhytides, surgical scars, dyschromia, melasma, enlarged pores, and transdermal drug delivery. The significant increase in minimally invasive procedures that has been reported over the past several years suggest that microneedling may occupy a specific niche for patients who desire measurable clinical results from treatments with little to no recovery.
Microneedling Therapy for Atrophic Acne Scars: An Objective Evaluation. [2022]Treatment of acne scarring is always a challenge. Microneedling therapy or percutaneous collagen induction is a new addition to the treatment modalities for such scars and has been reported to be simple and effective in atrophic acne scar treatment. The aim of this study is to evaluate the clinical effect and objectively quantify the histological changes of acne scarring in response to skin microneedling.