Treatment of Hypertrophic Scars With Intradermal Botox
1 other identifier
interventional
20
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for phase_2
Started Oct 2018
Shorter than P25 for phase_2
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
August 9, 2018
CompletedFirst Posted
Study publicly available on registry
August 15, 2018
CompletedStudy Start
First participant enrolled
October 1, 2018
CompletedPrimary Completion
Last participant's last visit for primary outcome
May 31, 2019
CompletedStudy Completion
Last participant's last visit for all outcomes
May 31, 2019
CompletedSeptember 26, 2018
September 1, 2018
8 months
August 9, 2018
September 25, 2018
Conditions
Outcome Measures
Primary Outcomes (1)
Improvement of hypertrophic scars based on the Subject and Observer Scar Assessment Scale
change from baseline at 6 months after treatment
Study Arms (1)
Botox
EXPERIMENTALInterventions
Intradermal injection with Botox 100U/mL will be performed using a 25g needle. Each subject will receive three treatments spaced 1 month apart.
Eligibility Criteria
You may qualify if:
- 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.
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Roy G. Geronemus, M.D.lead
- Allergancollaborator
Study Sites (1)
Laser & Skin Surgery Center of New York
New York, New York, 10016, United States
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- NA
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR INVESTIGATOR
- PI Title
- Principal Investigator
Study Record Dates
First Submitted
August 9, 2018
First Posted
August 15, 2018
Study Start
October 1, 2018
Primary Completion
May 31, 2019
Study Completion
May 31, 2019
Last Updated
September 26, 2018
Record last verified: 2018-09