Treatment of Hypertrophic Scars With Intradermal Botox

Hypertrophic Scar Clinical Trial

Official title:

Treatment of Hypertrophic Scars With Intradermal Botox

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03631368
• Other study ID #: LSSC-BOTOXSCAR-2018
• Status: Recruiting
• Phase: Phase 2
• Start date: October 1, 2018
• Est. completion date: May 31, 2019

Study information

• Verified date: September 2018
• Source: Laser and Skin Surgery Center of New York
• Contact: Jennifer Moreno
• Phone: 212-686-7306
• Email: research[@]laserskinsurgery.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 20
• Est. completion date: May 31, 2019
• Est. primary completion date: May 31, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 75 Years

Eligibility

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.

Related Conditions & MeSH terms

• Cicatrix, Hypertrophic
• Hypertrophic Scar
• Hypertrophy

Intervention

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.

Locations

Country	Name	City	State
United States	Laser & Skin Surgery Center of New York	New York	New York

Sponsors (2)

Lead Sponsor	Collaborator
Roy G. Geronemus, M.D.	Allergan

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Improvement of hypertrophic scars based on the Subject and Observer Scar Assessment Scale		change from baseline at 6 months after treatment