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Treatment of Hypertrophic Scars With Intradermal Botox

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ClinicalTrials.gov Identifier: NCT03631368
Recruitment Status : Recruiting
First Posted : August 15, 2018
Last Update Posted : September 26, 2018
Sponsor:
Collaborator:
Allergan
Information provided by (Responsible Party):
Roy G. Geronemus, M.D., Laser and Skin Surgery Center of New York

Tracking Information
First Submitted Date  ICMJE August 9, 2018
First Posted Date  ICMJE August 15, 2018
Last Update Posted Date September 26, 2018
Estimated Study Start Date  ICMJE October 1, 2018
Estimated Primary Completion Date May 31, 2019   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: August 13, 2018)
Improvement of hypertrophic scars based on the Subject and Observer Scar Assessment Scale [ Time Frame: change from baseline at 6 months after treatment ]
Original Primary Outcome Measures  ICMJE Same as current
Change History Complete list of historical versions of study NCT03631368 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE Not Provided
Original Secondary Outcome Measures  ICMJE Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Treatment of Hypertrophic Scars With Intradermal Botox
Official Title  ICMJE Treatment of Hypertrophic Scars With Intradermal Botox
Brief 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.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 2
Study Design  ICMJE Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Hypertrophic Scar
Intervention  ICMJE Drug: Botox
Intradermal injection with Botox 100U/mL will be performed using a 25g needle. Each subject will receive three treatments spaced 1 month apart.
Study Arms  ICMJE Experimental: Botox
Intervention: Drug: Botox
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Recruiting
Estimated Enrollment  ICMJE
 (submitted: August 13, 2018)
20
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE May 31, 2019
Estimated Primary Completion Date May 31, 2019   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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 and requirements.
  6. Able to understand and provide written Informed Consent.

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 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.
  9. History of intralesional corticosteroids or any other injectable medication to the area 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 might make it unsafe for the subject to participate in this study.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 75 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE
Contact: Jennifer Moreno 212-686-7306 research@laserskinsurgery.com
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03631368
Other Study ID Numbers  ICMJE LSSC-BOTOXSCAR-2018
Has Data Monitoring Committee Not Provided
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Roy G. Geronemus, M.D., Laser and Skin Surgery Center of New York
Study Sponsor  ICMJE Roy G. Geronemus, M.D.
Collaborators  ICMJE Allergan
Investigators  ICMJE Not Provided
PRS Account Laser and Skin Surgery Center of New York
Verification Date September 2018

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP