Treatment of Hypertrophic Scars With Intradermal Botox
Status unconfirmed · Phase 2
Conditions studied: Hypertrophic Scar
In brief
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.
Key facts
- Study ID
- NCT03631368
- Run by
- Roy G. Geronemus, M.D.
- People needed
- 20
- Starts
- 2018-10-01
- Expected to finish
- 2019-05-31
- Last updated by the study team
- 2018-09-26
Who can join
Age: 18 and older, up to 75. Sex: any. Healthy volunteers: not accepted.
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.
Where it is running
- Laser & Skin Surgery Center of New York — New York, New York, United States (enrolling)
Full record on ClinicalTrials.gov
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