Examining the Therapeutic Potential of Botulinum Toxin Type A in the Treatment of Keloids

  • STATUS
    Recruiting
  • End date
    Jan 2, 2032
  • participants needed
    10
  • sponsor
    University of California, San Diego
Updated on 2 May 2022
botulinum toxin
laser therapy
drug test
botulinum toxin type a
keloid
Accepts healthy volunteers

Summary

Keloids are a common form of hypertrophic scars that by definition last beyond 6 months and grow beyond the site of initial injury. Keloids are a common complaint from patients in dermatology and cause significant functional impairment due to cosmetic disfigurement, itching and pain. Current treatment modalities include intralesional corticosteroids, chemotherapeutic agents and laser therapy. Initial reports have demonstrated that Botulinum toxin type A may be a viable treatment option for keloids that can reduce keloid size and reduce associated symptoms while having fewer side effects when compared to intralesional corticosteroid injection, which can cause unnatural blood vessel growth or skin thinning. To date, no study has carefully examined the efficacy of Botulinum toxin type A in treating keloids or its mechanistic effects on keloid biology. Our aim in this study is to pursue a rigorous, randomized control trial to assess the potential use Botulinum toxin type A to treat keloids. Efficacy will be objectively be mentioned by change in keloid size after treatment, along with subjective measures of patient satisfaction and symptoms, and finally physician rated scores. Also, samples from three patients will be analyzed in the laboratory setting to determine the underlying molecular mechanism behind the effects of Botulinum toxin type A on keloid biology.

Details
Condition Keloid
Treatment Botulinum Toxin Type A, Vehicle
Clinical Study IdentifierNCT05330078
SponsorUniversity of California, San Diego
Last Modified on2 May 2022

Eligibility

Yes No Not Sure

Inclusion Criteria

Adults aged 18 to 80
History of keloid scar for at least 12 months
Absence of keloid treatment for past 12 months
Participant must have a keloid scar of at least 4cm in length
Participants who score at least 8 or higher on the Vancouver Scar Scale
Subjects who score 5 (neither satisfied nor dissatisfied) to 10 (maximally dissatisfied) on the patient subjective score of dissatisfaction with keloid
Participants must be in stable health, as confirmed by medical history, per investigator judgment
Participants must be able to read, sign, and understand the informed consent
Participants must be willing to avoid any other treatments to the keloid that will be treated including corticosteroid injections, surgical excision, chemotherapeutic injection, lasers, light-based therapy, radiation therapy, cryotherapy, or pressure therapy, during the study period

Exclusion Criteria

Pregnant women
Keloids on face, neck or scalp
History of hypersensitivity to botulinum toxin
Ongoing or planned treatment with chemotherapy, radiation, isotretinoin, cytokine-based immunotherapies
Any planned surgery during study period
Known diagnosis of insulin dependent diabetes mellitus
Patients being treating with dupilumab for any indication
Patients taking aminoglycoside antibiotics
Patients with pre-existing neuromuscular disorders
Patients with infection around potential injection sites
Clear my responses

How to participate?

Step 1 Connect with a study center
What happens next?
  • You can expect the study team to contact you via email or phone in the next few days.
  • Sign up as volunteer to help accelerate the development of new treatments and to get notified about similar trials.

You are contacting

Investigator Avatar

Primary Contact

site

0/250

Additional screening procedures may be conducted by the study team before you can be confirmed eligible to participate.

Learn more

If you are confirmed eligible after full screening, you will be required to understand and sign the informed consent if you decide to enroll in the study. Once enrolled you may be asked to make scheduled visits over a period of time.

Learn more

Complete your scheduled study participation activities and then you are done. You may receive summary of study results if provided by the sponsor.

Learn more

Similar trials to consider

Loading...

Browse trials for

Not finding what you're looking for?

Every year hundreds of thousands of volunteers step forward to participate in research. Sign up as a volunteer and receive email notifications when clinical trials are posted in the medical category of interest to you.

Sign up as volunteer

user name

Added by • 

 • 

Private

Reply by • Private
Loading...

Lorem ipsum dolor sit amet consectetur, adipisicing elit. Ipsa vel nobis alias. Quae eveniet velit voluptate quo doloribus maxime et dicta in sequi, corporis quod. Ea, dolor eius? Dolore, vel!

  The passcode will expire in None.
Loading...

No annotations made yet

Add a private note
  • abc Select a piece of text from the left.
  • Add notes visible only to you.
  • Send it to people through a passcode protected link.
Add a private note