Treatment of Hypertrophic Scars With Intradermal Botox

R

Roy G. Geronemus, M.D.

Status and phase

Unknown
Phase 2

Conditions

Hypertrophic Scar

Treatments

Drug: Botox

Study type

Interventional

Funder types

Other
Industry

Identifiers

NCT03631368
LSSC-BOTOXSCAR-2018

Details and patient eligibility

About

This is a prospective, open label, single center, self-controlled clinical study to demonstrate the safety and efficacy of intradermal botulinum toxin in treating hypertrophic scarring.

Enrollment

20 estimated patients

Sex

All

Ages

18 to 75 years old

Volunteers

No Healthy Volunteers

Inclusion criteria

  • Healthy female and male subjects between the ages 18-75.
  • Non-Smoker.
  • Fitzpatrick skin type I-VI.
  • Desire to improve hypertrophic scarring.
  • Able and willing to comply with all visit, treatment and evaluation schedules and requirements.
  • Able to understand and provide written Informed Consent.

Exclusion criteria

  • Pregnant or planning to become pregnant, having given birth less than 3 months ago, and/or breast feeding.
  • Presence of any active systemic or local infections.
  • Presence of active local skin disease that may alter wound healing.
  • Known allergy to botulinum toxin.
  • History of smoking in past 10 years.
  • History of chronic drug or alcohol abuse.
  • Inability to understand the protocol or to give informed consent.
  • History of cosmetic treatments in the area to be treated, including injectable filler of any type within the past year; Botox in the treatment area within the past 6 months; ablative or non-ablative resurfacing/rejuvenation laser treatment or light treatment within the past 6 months, dermabrasion or deep peels within the past 6 months; surgery to the area within the past 6 months.
  • History of intralesional corticosteroids or any other injectable medication to the area within the last 3 months.
  • History of topical corticosteroids to the area within the past 4 weeks.
  • History of any musculoskeletal disease or any weakness in the area to be treated.
  • As per the investigator's discretion, any physical or mental condition which might make it unsafe for the subject to participate in this study.

Trial design

Primary purpose

Treatment

Allocation

N/A

Interventional model

Single Group Assignment

Masking

None (Open label)

20 participants in 1 patient group

Botox
Experimental group
Treatment:
Drug: Botox

Trial contacts and locations

1

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Central trial contact

Jennifer Moreno

Data sourced from clinicaltrials.gov

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