Microneedling for Burn Scars

Recruiting at 1 trial location

Overseen By Bernadette Nedelec

Age: Any Age

Sex: Any

Trial Phase: Academic

Sponsor: Centre hospitalier de l'Université de Montréal (CHUM)

Must not be taking: Anticoagulants

Disqualifiers: Keloid scars, Psychiatric condition, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Approved in 3 Jurisdictions This treatment is already approved in other countries

Compensation: Varies

Number of Visits: 7

Duration: 30 weeks

36 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores the effectiveness of microneedling in improving burn scars that are raised, red, and rigid, often causing discomfort and distress. Microneedling uses a device to create tiny channels in the skin, followed by cortisone application to reduce scar thickness and redness. Participants must have at least two such scars to join the trial. By treating one scar and comparing it to another without treatment, researchers aim to determine if microneedling makes a noticeable difference.

As an unphased trial, this study offers participants the chance to contribute to innovative research that could enhance scar treatment options.

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 prior data suggests that microneedling is safe for treating burn scars?

Research has shown that microneedling is generally safe with few side effects. Studies indicate it is a well-tolerated method for treating scars, including those from burns. Most people experience only mild effects like redness or slight swelling, which usually disappear quickly.

A review of microneedling found it to be a safe option with few serious issues reported. It is considered minimally invasive, meaning it doesn't involve major surgery or long recovery times. This makes it a popular choice for improving the appearance of scars.

In summary, microneedling has a good safety record, making it a promising treatment for those seeking to improve hypertrophic burn scars. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Unlike the standard care for burn scars, which often involves topical treatments, surgery, or laser therapy, microneedling offers a minimally invasive approach. Researchers are excited about microneedling because it uses tiny needles to create micro-injuries, prompting the skin's natural healing process and stimulating collagen production. This method can improve the texture and appearance of scars without the downtime associated with more invasive procedures. Additionally, microneedling may enhance the absorption of topical treatments applied afterward, potentially boosting overall effectiveness.

What evidence suggests that microneedling is effective for improving hypertrophic burn scars?

Research has shown that microneedling, which participants in this trial may receive, can significantly improve the appearance of raised scars, including those from burns. Studies have found that microneedling smooths scars and enhances skin texture, with effects lasting up to a year after treatment. This technique involves creating tiny holes in the skin, which not only directly treats scars but also increases the skin's ability to absorb beneficial products like cortisone by about 80%. Many patients consider microneedling a safe and satisfying method for treating scars. Overall, microneedling is regarded as a promising option for improving the quality and appearance of scars. ^{1 3 6 7 8}

Are You a Good Fit for This Trial?

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

Exclusion Criteria

I cannot understand English or French.

My surgical scar has fully healed.

I am currently taking blood thinner medications.

Timeline for a Trial Participant

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)

What Are the Treatments Tested in This Trial?

Interventions

• Microneedling

Trial Overview 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.

How Is the Trial Designed?

Group I: Microneedling treated scar Experimental Treatment 1 Intervention

Microneedling

Group II: Control scar Active Control 1 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

Who Is Running the Clinical Trial?

Centre hospitalier de l'Université de Montréal (CHUM)

Lead Sponsor

Trials

389

Recruited

143,000+

Published Research Related to This Trial

Microneedling is a safe and effective treatment for various dermatological conditions, including scars, acne, melasma, and skin rejuvenation, with minimal permanent adverse effects reported.

While transient side effects like redness and hyperpigmentation can occur, the procedure is generally well-tolerated, and further research with larger randomized trials is needed to explore its efficacy across different skin types.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Microneedling: A Comprehensive Review. Hou, A., Cohen, B., Haimovic, A., et al.[2017]

Microneedling is an effective treatment for various skin conditions, particularly acne scars and cosmetic rejuvenation, and has shown benefits for other issues like burn scars and alopecia, with mild and self-limited side effects.

The procedure is considered safe and cost-effective for all skin types, although more rigorous studies are needed to confirm its efficacy across different conditions.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Microneedling in All Skin Types: A Review. Bonati, LM., Epstein, GK., Strugar, TL.[2017]

In a study of 120 patients with various types of scars, microneedling resulted in at least 50% improvement in all cases after an average of 2.5 treatments, with over 80% of patients experiencing 50 to 75% improvement and 65% showing over 75% improvement.

The study demonstrated that microneedling is effective for treating both facial and nonfacial scars across different skin types, with minimal side effects, suggesting it is a safe and versatile treatment option.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Microneedling of Scars: A Large Prospective Study with Long-Term Follow-Up. Alster, TS., Li, MKY.[2021]

Microneedles (MNs) have gained popularity in cosmetics, but their safety profile is still being established as the FDA begins to regulate these devices.

Current literature indicates that while MNs are widely used, there is a need for more research to fully understand potential adverse effects, such as infections and skin reactions, associated with their use.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Dermatotoxicology of microneedles (MNs) in man. Cary, JH., Li, BS., Maibach, HI.[2020]

Microneedling therapy is an effective treatment for atrophic acne scars, showing noticeable clinical improvement in patients after six sessions over three months, as evaluated through patient assessments and histological changes.

The treatment significantly increased collagen types I, III, and VII, as well as newly synthesized collagen, while reducing total elastin, indicating a positive remodeling effect on the skin.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Microneedling Therapy for Atrophic Acne Scars: An Objective Evaluation. El-Domyati, M., Barakat, M., Awad, S., et al.[2022]

Minimally invasive percutaneous collagen induction is a safe and effective treatment for improving the appearance of postsurgical scars, as shown by significant improvements in scar assessment scores in a study of 25 patients.

Starting treatment early (6 to 7 weeks post-surgery) leads to better aesthetic outcomes compared to starting later (13 to 16 weeks post-surgery), highlighting the importance of timing in scar management.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Microneedling Outcomes in Early Postsurgical Scars. Claytor, RB., Sheck, CG., Chopra, V.[2022]

Microneedling is a safe and effective minimally invasive treatment for various skin conditions, including acne scars, wrinkles, and stretch marks, with significant clinical improvements and quick recovery times.

The treatment works by creating controlled micro-injuries in the skin, which stimulates the body's natural wound healing process and boosts collagen production, leading to enhanced skin rejuvenation.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Microneedling: A Review and Practical Guide. Alster, TS., Graham, PM.[2018]

Percutaneous collagen induction (PCI) significantly improved the appearance of post-burn scars, with patients reporting an average improvement of 80% after treatment, based on a visual analogue scale.

Histological analysis 12 months after PCI showed increased collagen and elastin deposition, along with a 45% thickening of the epidermis, indicating that PCI promotes healthy skin remodeling without damaging the epidermis.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Percutaneous collagen induction therapy: an alternative treatment for burn scars. Aust, MC., Knobloch, K., Reimers, K., et al.[2022]

Microneedling with the Dermaroller® has shown promising results in improving the quality of burn scars, as evidenced by a subjective improvement reported by patients and an objective average reduction of two points in the Vancouver Scar Score after treatment.

In a pilot study involving six patients, the microneedling procedure was performed three times at 6 to 8-week intervals, indicating that this method can effectively activate the healing process and enhance collagen production in scar tissue.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

MICRONEEDLING - A FORM OF COLLAGEN INDUCTION THERAPY - OUR FIRST EXPERIENCES. Šuca, H., Zajíček, R., Vodsloň, Z.[2019]

Microneedling is an effective treatment for photoaged skin, leading to significant clinical improvements and increased production of collagen types I, III, and VII after six sessions in ten patients with aging skin.

The treatment resulted in a notable increase in newly synthesized collagen and tropoelastin, although total elastin levels decreased, indicating a complex response in skin remodeling that requires multiple sessions for sustained benefits.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Multiple microneedling sessions for minimally invasive facial rejuvenation: an objective assessment. El-Domyati, M., Barakat, M., Awad, S., et al.[2015]

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC6880027/

Percutaneous collagen induction (microneedling) for the ... Level 3 data suggest that needling can render significant resurfacing effects to both mature and actively hypertrophic burn scars at 12-month ...

2. sciencedirect.com sciencedirect.com/science/article/abs/pii/S1748681517302504

Review Microneedling: Where do we stand now? A ... This systematic review positions microneedling as a safe and effective therapeutic option for the treatment of scars and wrinkles.

3. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC7764156/

Microneedling for the Treatment of Scars MN is a well-tolerated, minimally invasive procedure that can be used for the treatment of scars with a high level of patient satisfaction.

4. journals.sagepub.com journals.sagepub.com/doi/10.1177/2059513119880301

Percutaneous collagen induction (microneedling) for the ... Level 3 data suggest that needling can render significant resurfacing effects to both mature and actively hypertrophic burn scars at 12-month ...

5. cureus.com cureus.com/articles/353772-microneedling-for-anterior-neck-surgical-scars-a-systematic-review-of-effectiveness-and-evidence-gaps

Microneedling for Anterior Neck Surgical Scars However, emerging evidence indicates that early interventions, such as microneedling, may enhance collagen remodelling and improve scar quality ...

6. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC7869810/

A Systematic Review Examining the Potential Adverse ... This review found that microneedling, regardless of the specific device used, is a relatively safe procedure with minimal adverse effects.

7. iranjd.ir iranjd.ir/article_227020_8024a879eca0ec55304b9d28bebc0e91.pdf

Microneedling side effects and complications Microneedling is widely recognized as a minimally invasive cosmetic procedure with generally favorable safety outcomes and a low incidence of severe ...

8. semanticscholar.org semanticscholar.org/paper/Safety-and-efficacy-of-microneedling-technology-in-Casabona-Alfertshofer/dd0e026e25b5470817fe8b802ccd04dbdf7a557a

Safety and efficacy of microneedling technology in the ... Percutaneous collagen induction via microneedling poses an alternative treatment method due to its low rates of reported adverse events and side effects.