Recruiting
Phase 2

Intradermal Botox

Sponsor:

Roy G. Geronemus, M.D.

Code:

NCT03631368

Conditions

Hypertrophic Scar

Eligibility Criteria

Sex: All

Age: 18 - 70+

Healthy Volunteers: Not accepted

Interventions

Botox

Study Details

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.

Conditions

Hypertrophic Scar

Study ID

NCT03631368

Start date

Oct 1, 2018

Status verified date

Sep, 2018

Completion date

May 31, 2019

Anticipated

Primary completion date

May 31, 2019

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18 - 70+

Healthy Volunteers: Not accepted

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

Enrollment

20 participants

Anticipated

Intervention Model

Single group

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: Botox

Interventions

Botox

Intradermal injection with Botox 100U/mL will be performed using a 25g needle. Each subject will receive three treatments spaced 1 month apart.

Primary outcome measure

  • Improvement of hypertrophic scars based on the Subject and Observer Scar Assessment Scale [ Time Frame: change from baseline at 6 months after treatment ]

Central Contacts and Locations

Central contacts

Locations

Laser & Skin Surgery Center of New York

Recruiting

New York, New York, United States, 10016

Contacts

More Information

Sponsor

Roy G. Geronemus, M.D.

Last update posted

Sep 26, 2018

Last verified

Sep, 2018

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Roy G. Geronemus, M.D. on 2018-09-26.