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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
Roy G. Geronemus, M.D.
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Hypertrophic Scar

Eligibility Criteria

18 Years - 75 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

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

First Posted
August 9, 2018
Last Updated
September 25, 2018
Sponsor
Roy G. Geronemus, M.D.
Collaborators
Allergan
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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

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Treatment of Hypertrophic Scars With Intradermal Botox

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