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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT03631368
Other study ID # LSSC-BOTOXSCAR-2018
Secondary ID
Status Recruiting
Phase Phase 2
First received
Last updated
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
Health authority
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.

Study Design


Related Conditions & MeSH terms


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
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