Botulinum Toxin for Keloids

Recruiting in Palo Alto (17 mi)

Age: 18+

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Phase < 1

Waitlist Available

Sponsor: University of California, San Diego

Approved in 3 Jurisdictions

Trial Summary

What is the purpose of this trial?

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.

Research Team

Eligibility Criteria

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.

Inclusion Criteria

History of keloid scar for at least 12 months

Participants who score at least 8 or higher on the Vancouver Scar Scale

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

Exclusion Criteria

History of hypersensitivity to botulinum toxin

I am currently taking aminoglycoside antibiotics.

Patients with pre-existing neuromuscular disorders

Treatment Details

Interventions

• Botulinum Toxin Type A (Neurotoxin)

Trial Overview 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.

Participant Groups

Group I: Keloid treatment with botulinum toxin type A Experimental Treatment 1 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 Group 1 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.

Botulinum Toxin Type A is already approved in Canada for the following indications:

Approved in Canada as Botox for:

• Temporary improvement in the appearance of moderate to severe glabellar lines associated with corrugator and/or procerus muscle activity
• Temporary improvement in the appearance of moderate to severe facial wrinkles and folds
• Axillary hyperhidrosis
• Blepharospasm
• Strabismus
• Cervical dystonia
• Chronic migraine
• Overactive bladder
• Detrusor overactivity associated with a neurologic condition

Who Is Running the Clinical Trial?

University of California, San Diego

Lead Sponsor

Trials

1,215

Recruited

1,593,000+

Dr. Christopher Longhurst

University of California, San Diego

Chief Medical Officer since 2021

MD and MS in Medical Informatics from UC Davis

Patty Maysent

University of California, San Diego

Chief Executive Officer since 2016

MBA from Stanford University