What side effects are associated with this type of intervention?

Common treatments for keloids include intralesional corticosteroids, chemotherapeutic agents, laser therapy, and Botulinum toxin type A. Intralesional corticosteroids can cause side effects such as skin thinning, hypopigmentation, and unnatural blood vessel growth. Chemotherapeutic agents may lead to local irritation and systemic toxicity. Laser therapy can result in temporary redness, swelling, and changes in skin pigmentation. Botulinum toxin type A, which is being studied for keloid treatment, has fewer side effects compared to corticosteroids, but potential side effects include localized pain, infection at the injection site, and transient muscle weakness.

What prior FDA approvals exist?

Currently, there are no FDA-approved treatments specifically for keloids that function in the same way as Botulinum toxin type A, which inhibits acetylcholine release at neuromuscular junctions to potentially reduce fibroblast activity and scar formation. Traditional treatments for keloids include intralesional corticosteroids, which are FDA-approved and work by reducing inflammation and collagen production. Other treatments like chemotherapeutic agents and laser therapy are also used, but their mechanisms differ from that of Botulinum toxin type A.

What other types of research exist?

Promising novel alternatives to Botulinum toxin type A for keloid treatment include: 1) Intralesional corticosteroids, which are commonly used but can have side effects like skin thinning and unnatural blood vessel growth. 2) Chemotherapeutic agents, which can reduce keloid size but may have systemic side effects. 3) Laser therapy, which can improve keloid appearance and symptoms. Emerging treatments under investigation include targeted molecular therapies and advanced laser technologies, which aim to minimize side effects while effectively managing keloid scars.

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Neurotoxin

Botulinum Toxin for Keloids

Q: What is the mechanism of action of this treatment?

Botulinum toxin type A, a common treatment for keloids, works by inhibiting the release of acetylcholine at neuromuscular junctions, which can reduce fibroblast activity and subsequent scar formation. This mechanism is significant for keloid patients as it potentially minimizes the size and symptoms of keloids, such as itching and pain, while avoiding the side effects associated with other treatments like intralesional corticosteroids. By targeting the underlying cellular processes, Botulinum toxin type A offers a promising approach to managing keloid scars more effectively.

Phase < 1

Waitlist Available

Research Sponsored by University of California, San Diego

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Adults aged 18 to 80

Participant must have a keloid scar of at least 4cm in length

Must not have

Patients taking aminoglycoside antibiotics

Patients with infection around potential injection sites

Timeline

Screening 3 weeks

Treatment Varies

Follow Up measurements obtained at 0 and 24 weeks.

Awards & highlights

All Individual Drugs Already Approved

Summary

This trial is testing Botox to see if it can help people with keloid scars. Keloids are tough scars that don't respond well to usual treatments and can cause discomfort. Botox might help by relaxing the tissue and reducing the scar's size and symptoms.

Who is the study for?

This trial is for adults aged 18-80 with keloid scars at least 4cm long, lasting over a year, and scoring ≥8 on the Vancouver Scar Scale. Participants must be in stable health and not have had any keloid treatments in the past year. Pregnant individuals, those with facial/neck/scalp keloids, botulinum toxin hypersensitivity, or certain medical conditions are excluded.

What is being tested?

The study tests Botulinum toxin type A's effectiveness against keloids compared to a placebo (vehicle). It measures changes in scar size, patient satisfaction, symptoms relief and physician assessments. The trial randomly assigns participants to receive either the treatment or placebo.

What are the potential side effects?

Botulinum toxin type A may cause localized pain at injection site, muscle weakness near treated area, flu-like symptoms or allergic reactions. Compared to corticosteroids used for keloids which can thin skin or cause abnormal blood vessels growth.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I am between 18 and 80 years old.

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I have a keloid scar that is at least 4cm long.

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I agree not to seek other treatments for my keloid during the study.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I am currently taking aminoglycoside antibiotics.

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I have an infection near where I might get an injection.

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I am currently being treated with dupilumab.

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I have no surgeries planned during the study period.

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I am currently undergoing or planning to start treatment with chemotherapy, radiation, isotretinoin, or cytokine-based immunotherapies.

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I have keloids on my face, neck, or scalp.

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I have diabetes that requires insulin treatment.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ measurements obtained at 0 and 24 weeks.

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~measurements obtained at 0 and 24 weeks.

This trial's timeline: 3 weeks for screening, Varies for treatment, and measurements obtained at 0 and 24 weeks. for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Change in Keloid volume

Side effects data

From 2016 Phase 4 trial • 42 Patients • NCT02321436

Head injury

Insomnia

Pain

Asthma

Tachycardia

Constipation

Pyrexia

Cough

Hypertensive crisis

Pneumonia

Vomiting

Fall

Hypokalaemia

Urinary tract infection

100%

80%

60%

40%

20%

Study treatment Arm

Dysport ® 500 U

Placebo

Awards & Highlights

All Individual Drugs Already Approved

Therapies where all constituent drugs have already been approved are likely to have better-understood side effect profiles.

Trial Design

2Treatment groups

Experimental Treatment

Placebo Group

Group I: Keloid treatment with botulinum toxin type AExperimental Treatment1 Intervention

Participants will receive Botulinum toxin type A 5 units / cm3 with injections of 0.2mL spaced evenly 1cm apart within the treatment area (half of the keloid). Each treatment will consist of a maximum of 2 mL (10 injection sites, 50 unit total) of the study drug. Patients will undergo 3 treatments, 6 weeks apart.

Group II: Keloid treatment with vehicle control (saline)Placebo Group1 Intervention

Participants will receive saline injections of 0.2mL spaced evenly 1cm apart within the placebo area (half of the keloid). Each treatment will consist of a maximum of 2 mL (10 injection sites) of the vehicle control (saline). Patients will undergo 3 treatments, 6 weeks apart.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Botulinum toxin type A

FDA approved

0 / 10Eligibility criteria met

Research Highlights

Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.

Mechanism Of Action

Side Effect Profile

Prior Approvals

Other Research

Botulinum toxin type A, a common treatment for keloids, works by inhibiting the release of acetylcholine at neuromuscular junctions, which can reduce fibroblast activity and subsequent scar formation. This mechanism is significant for keloid patients as it potentially minimizes the size and symptoms of keloids, such as itching and pain, while avoiding the side effects associated with other treatments like intralesional corticosteroids. By targeting the underlying cellular processes, Botulinum toxin type A offers a promising approach to managing keloid scars more effectively.