Treatment of Hypertrophic Scars With Intradermal Botox

Last updated: September 25, 2018
Sponsor: Roy G. Geronemus, M.D.
Overall Status: Active - Recruiting

Phase

2

Condition

Scar Tissue

Treatment

N/A

Clinical Study ID

NCT03631368
LSSC-BOTOXSCAR-2018
  • Ages 18-75
  • All Genders

Study Summary

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.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  1. Healthy female and male subjects between the ages 18-75.

  2. Non-Smoker.

  3. Fitzpatrick skin type I-VI.

  4. Desire to improve hypertrophic scarring.

  5. Able and willing to comply with all visit, treatment and evaluation schedules andrequirements.

  6. Able to understand and provide written Informed Consent.

Exclusion

Exclusion Criteria:

  1. Pregnant or planning to become pregnant, having given birth less than 3 months ago,and/or breast feeding.

  2. Presence of any active systemic or local infections.

  3. Presence of active local skin disease that may alter wound healing.

  4. Known allergy to botulinum toxin.

  5. History of smoking in past 10 years.

  6. History of chronic drug or alcohol abuse.

  7. Inability to understand the protocol or to give informed consent.

  8. History of cosmetic treatments in the area to be treated, including injectable fillerof any type within the past year; Botox in the treatment area within the past 6months; ablative or non-ablative resurfacing/rejuvenation laser treatment or lighttreatment within the past 6 months, dermabrasion or deep peels within the past 6months; surgery to the area within the past 6 months.

  9. History of intralesional corticosteroids or any other injectable medication to thearea within the last 3 months.

  10. History of topical corticosteroids to the area within the past 4 weeks.

  11. History of any musculoskeletal disease or any weakness in the area to be treated.

  12. As per the investigator's discretion, any physical or mental condition which mightmake it unsafe for the subject to participate in this study.

Study Design

Total Participants: 20
Study Start date:
October 01, 2018
Estimated Completion Date:
May 31, 2019

Connect with a study center

  • Laser & Skin Surgery Center of New York

    New York, New York 10016
    United States

    Active - Recruiting

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