Treatment of Hypertrophic Scars With Intradermal Botox

September 25, 2018 updated by: Roy G. Geronemus, M.D.
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.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Anticipated)

20

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 75 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Improvement of hypertrophic scars based on the Subject and Observer Scar Assessment Scale
Time Frame: change from baseline at 6 months after treatment
change from baseline at 6 months after treatment

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Roy G. Geronemus, M.D.

Collaborators

Allergan

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Anticipated)

October 1, 2018

Primary Completion (Anticipated)

May 31, 2019

Study Completion (Anticipated)

May 31, 2019

Study Registration Dates

First Submitted

August 9, 2018

First Submitted That Met QC Criteria

August 13, 2018

First Posted (Actual)

August 15, 2018

Study Record Updates

Last Update Posted (Actual)

September 26, 2018

Last Update Submitted That Met QC Criteria

September 25, 2018

Last Verified

September 1, 2018

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • LSSC-BOTOXSCAR-2018

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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