Treatment of Hypertrophic Scars With Intradermal Botox
Primary Purpose
Hypertrophic Scar
Status
Unknown status
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
Botox
Sponsored by
About this trial
This is an interventional treatment trial for Hypertrophic Scar
Eligibility Criteria
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.
Sites / Locations
- Laser & Skin Surgery Center of New YorkRecruiting
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Botox
Arm Description
Outcomes
Primary Outcome Measures
Improvement of hypertrophic scars based on the Subject and Observer Scar Assessment Scale
Secondary Outcome Measures
Full Information
NCT ID
NCT03631368
First Posted
August 9, 2018
Last Updated
September 25, 2018
Sponsor
Roy G. Geronemus, M.D.
Collaborators
Allergan
1. Study Identification
Unique Protocol Identification Number
NCT03631368
Brief Title
Treatment of Hypertrophic Scars With Intradermal Botox
Official Title
Treatment of Hypertrophic Scars With Intradermal Botox
Study Type
Interventional
2. Study Status
Record Verification Date
September 2018
Overall Recruitment Status
Unknown status
Study Start Date
October 1, 2018 (Anticipated)
Primary Completion Date
May 31, 2019 (Anticipated)
Study Completion Date
May 31, 2019 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor-Investigator
Name of the Sponsor
Roy G. Geronemus, M.D.
Collaborators
Allergan
4. Oversight
Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Hypertrophic Scar
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
20 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Botox
Arm Type
Experimental
Intervention Type
Drug
Intervention Name(s)
Botox
Intervention Description
Intradermal injection with Botox 100U/mL will be performed using a 25g needle. Each subject will receive three treatments spaced 1 month apart.
Primary Outcome Measure Information:
Title
Improvement of hypertrophic scars based on the Subject and Observer Scar Assessment Scale
Time Frame
change from baseline at 6 months after treatment
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Jennifer Moreno
Phone
212-686-7306
Email
research@laserskinsurgery.com
Facility Information:
Facility Name
Laser & Skin Surgery Center of New York
City
New York
State/Province
New York
ZIP/Postal Code
10016
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Jennifer Moreno
Phone
212-686-7306
Email
research@laserskinsurgery.com
12. IPD Sharing Statement
Learn more about this trial
Treatment of Hypertrophic Scars With Intradermal Botox
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