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Treatment of Hypertrophic Scars With Intradermal Botox

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03631368
Recruitment Status : Unknown
Verified September 2018 by Roy G. Geronemus, M.D., Laser and Skin Surgery Center of New York.
Recruitment status was:  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

Study Description
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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.

Condition or disease Intervention/treatment Phase
Hypertrophic Scar Drug: Botox Phase 2

Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 20 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Treatment of Hypertrophic Scars With Intradermal Botox
Estimated Study Start Date : October 1, 2018
Estimated Primary Completion Date : May 31, 2019
Estimated Study Completion Date : May 31, 2019

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Botox Scars

Arms and Interventions
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Arm Intervention/treatment
Experimental: Botox 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.


Outcome Measures
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Primary Outcome Measures :
  1. Improvement of hypertrophic scars based on the Subject and Observer Scar Assessment Scale [ Time Frame: change from baseline at 6 months after treatment ]

Eligibility Criteria
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Ages Eligible for Study:   18 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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.
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03631368


Contacts
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Contact: Jennifer Moreno 212-686-7306 research@laserskinsurgery.com

Locations
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United States, New York
Laser & Skin Surgery Center of New York Recruiting
New York, New York, United States, 10016
Contact: Jennifer Moreno    212-686-7306    research@laserskinsurgery.com   
Sponsors and Collaborators
Roy G. Geronemus, M.D.
Allergan
More Information
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Responsible Party: Roy G. Geronemus, M.D., Principal Investigator, Laser and Skin Surgery Center of New York
ClinicalTrials.gov Identifier: NCT03631368    
Other Study ID Numbers: LSSC-BOTOXSCAR-2018
First Posted: August 15, 2018    Key Record Dates
Last Update Posted: September 26, 2018
Last Verified: September 2018

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Hypertrophy
Cicatrix, Hypertrophic
Pathological Conditions, Anatomical
 Cicatrix
Fibrosis
Pathologic Processes