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Neurotoxin

Botulinum Toxin for Keloids

Q: What criteria must be met for someone to qualify as a participant in this experiment?

This clinical trial aims to recruit 10 adults aged 18 and 80 with keloid scars persisting for at least a year. Qualifying individuals must have an appropriate score on the Vancouver Scar Scale, be discontent with their scar as specified by patient subjective scoring, possess stable health judged by medical history review, understand the informed consent form in its entirety, demonstrate a minimum of 4cm-long keloid scarring, abstain from any other treatments such as steroid injections or cryotherapy throughout the study's duration.

Q: How many research participants are involved in this clinical investigation?

Affirmative. Clinicaltrials.gov provides evidence that this clinical trial is open for patient participation, having been first posted on March 11th 2022 and last updated April 8th 2022. Currently, the study requires 10 volunteers to be recruited from 1 medical centre.

Q: Does this trial accept applicants over the age of thirty-five?

This clinical investigation is open to individuals over 18 and below 80 years of age.

Q: Are there any opportunities available for participation in this clinical trial?

Affirmative. Information available on clinicaltrials.gov attests that this experiment is actively searching for participants, having originally been posted on March 11th 2022 and was last modified April 8th 2022. This search requires 10 patients from one centre to be recruited.

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

Timeline

Screening 3 weeks

Treatment Varies

Follow Up measurements obtained at 0 and 24 weeks.

Awards & highlights

Study Summary

This trial will assess whether Botulinum toxin type A is an effective treatment for keloids, which are a common and painful type of scar.

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.Check my eligibility

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.See study design

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.

Select...

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.

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

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

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

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 / 3Eligibility criteria met

Find a Location

Who is running the clinical trial?

University of California, San DiegoLead Sponsor

1,120 Previous Clinical Trials

1,521,625 Total Patients Enrolled

Media Library

Botulinum Toxin Type A (Neurotoxin) Clinical Trial Eligibility Overview. Trial Name: NCT05330078 — Phase < 1

Botulinum Toxin Type A (Neurotoxin) 2023 Treatment Timeline for Medical Study. Trial Name: NCT05330078 — Phase < 1

Keloid Research Study Groups: Keloid treatment with vehicle control (saline), Keloid treatment with botulinum toxin type A

Keloid Clinical Trial 2023: Botulinum Toxin Type A Highlights & Side Effects. Trial Name: NCT05330078 — Phase < 1

Keloid Patient Testimony for trial: Trial Name: NCT05330078 — Phase < 1

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

What criteria must be met for someone to qualify as a participant in this experiment?

"This clinical trial aims to recruit 10 adults aged 18 and 80 with keloid scars persisting for at least a year. Qualifying individuals must have an appropriate score on the Vancouver Scar Scale, be discontent with their scar as specified by patient subjective scoring, possess stable health judged by medical history review, understand the informed consent form in its entirety, demonstrate a minimum of 4cm-long keloid scarring, abstain from any other treatments such as steroid injections or cryotherapy throughout the study's duration."

Answered by AI

How many research participants are involved in this clinical investigation?

"Affirmative. Clinicaltrials.gov provides evidence that this clinical trial is open for patient participation, having been first posted on March 11th 2022 and last updated April 8th 2022. Currently, the study requires 10 volunteers to be recruited from 1 medical centre."

Answered by AI

Does this trial accept applicants over the age of thirty-five?

"This clinical investigation is open to individuals over 18 and below 80 years of age."

Answered by AI

Are there any opportunities available for participation in this clinical trial?

"Affirmative. Information available on clinicaltrials.gov attests that this experiment is actively searching for participants, having originally been posted on March 11th 2022 and was last modified April 8th 2022. This search requires 10 patients from one centre to be recruited."

Answered by AI

Who else is applying?

What state do they live in?

Nevada

Maryland

California

How old are they?

18 - 65

What site did they apply to?

University of California San Diego

What portion of applicants met pre-screening criteria?

Did not meet criteria

Met criteria

How many prior treatments have patients received?

Why did patients apply to this trial?

have a keloid in my ear lobe and don’t have insurance to remove it. I tried surgical method and administering injections to site every 4 weeks. Keloids came back again.

PatientReceived 1 prior treatment