Treatment of Hypertrophic Scars With Intradermal Botox

Phase 2

• Conditions: Hypertrophic Scar
• Interventions: Drug: Botox

• Registration Number: NCT03631368
• Lead Sponsor: Roy G. Geronemus, M.D.

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2018-08-09
• Study First Submitted QC: 2018-08-13
• Study First Posted: 2018-08-15
• Status Verified: 2018-09
• Last Update Submitted: 2018-09-25
• Last Update Posted: 2018-09-26
• Study Start: 2018-10-01
• Primary Completion: 2019-05-31
• Study Completion: 2019-05-31

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 20

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Botox	Botox	-

Primary Outcome Measures

Name	Time	Method
Improvement of hypertrophic scars based on the Subject and Observer Scar Assessment Scale	change from baseline at 6 months after treatment

Trial Locations

Locations (1)

Laser & Skin Surgery Center of New York; 🇺🇸 New York, New York, United States