Hypertrophic ScarPhase 2NCT03631368
Treatment of Hypertrophic Scars With Intradermal Botox
A Phase 2 study testing Botox in people with Hypertrophic Scar, run by Roy G. Geronemus, M.D. at 1 site in United States.
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. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Hypertrophic Scar
- What is being tested?
- Botox
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Oct 2018to 31 May 2019
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
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- 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.
Trial locations and contacts
1 site in 1 country.
United States1 site, 1 recruiting
- Recruiting
Laser & Skin Surgery Center of New York
New York, New York, 10016
Jennifer Moreno, 212-686-7306, research@laserskinsurgery.com
About this study
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
- Being tested
- Botox
- Medical subject headings
- Cicatrix, Hypertrophic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
BotoxDrug
Intradermal injection with Botox 100U/mL will be performed using a 25g needle. Each subject will receive three treatments spaced 1 month apart.
| Study group | Role | What they receive |
|---|---|---|
| Botox | Experimental | Not described Receives: Drug: Botox |
What is being measured
The primary outcome is the main question the study is designed to answer.
Improvement of hypertrophic scars based on the Subject and Observer Scar Assessment Scale
Measured: change from baseline at 6 months after treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Aug 2018
- Study start1 Oct 2018 (estimated)
- Primary completion31 May 2019 (estimated)
- Study completion31 May 2019 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Hypertrophic ScarStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 20 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Roy G. Geronemus, M.D.
- Sponsor type
- University, hospital or other
- Collaborators
- Allergan
- Responsible party
- Sponsor-investigator, Roy G. Geronemus, M.D., Laser and Skin Surgery Center of New York
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03631368
- Sponsor's protocol ID
- LSSC-BOTOXSCAR-2018
- Status last verified
- Sep 2018
- First submitted
- 9 Aug 2018
- Last updated
- 26 Sep 2018
- Results posted
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 26 Sep 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Treatment of Hypertrophic Scars With Intradermal Botox
- ClinicalTrials.gov ID
- NCT03631368
- Acronym / sponsor ID
- LSSC-BOTOXSCAR-2018
- Conditions
- Hypertrophic Scar
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 20 participants (estimated)
- Lead sponsor
- Roy G. Geronemus, M.D.University, hospital or other
- Collaborators
- Allergan
- Study start
- 1 Oct 2018 (estimated)
- Primary completion
- 31 May 2019 (estimated)
- Study completion
- 31 May 2019 (estimated)
- First posted
- 15 Aug 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Botox | Experimental | Drug: Botox |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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.
Key exclusion criteria (12 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| BotoxIntradermal injection with Botox 100U/mL will be performed using a 25g needle. Each subject will receive three treatments spaced 1 month apart. | Drug | Botox |
Primary outcome
Improvement of hypertrophic scars based on the Subject and Observer Scar Assessment Scale
Time frame: change from baseline at 6 months after treatment
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Sep 2018.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Botox in people with Hypertrophic Scar, run by Roy G. Geronemus, M.D. at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 12 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 26 Sep 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Jennifer Moreno (212-686-7306, research@laserskinsurgery.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the 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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 26 Sep 2018.