Microneedling for Burn Scars

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

Trial Summary

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. ^{1 2 3 4 5}

Is 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. ^{2 4 6 7 8}

How 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. ^{2 3 4 9 10}

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.

Eligibility 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

Exclusion Criteria

I cannot understand English or French.

My surgical scar has fully healed.

I am currently taking blood thinner medications.

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)

Treatment Details

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.

Participant Groups

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+

Findings from Research

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]

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 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]

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]

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 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]

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]

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]

References

1. Netherlands pubmed.ncbi.nlm.nih.gov

Percutaneous collagen induction therapy: an alternative treatment for burn scars. [2022]

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

Microneedling Outcomes in Early Postsurgical Scars. [2022]

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

Multiple microneedling sessions for minimally invasive facial rejuvenation: an objective assessment. [2015]

4. Czech Republic pubmed.ncbi.nlm.nih.gov

MICRONEEDLING - A FORM OF COLLAGEN INDUCTION THERAPY - OUR FIRST EXPERIENCES. [2019]

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

Microneedling of Scars: A Large Prospective Study with Long-Term Follow-Up. [2021]

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

Dermatotoxicology of microneedles (MNs) in man. [2020]

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

Microneedling: A Comprehensive Review. [2017]

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

Microneedling in All Skin Types: A Review. [2017]

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

Microneedling: A Review and Practical Guide. [2018]

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

Microneedling Therapy for Atrophic Acne Scars: An Objective Evaluation. [2022]