Botox for Improving Scars After Cleft Lip Surgery
Cleft Lip Scarring After Botox
Recruiting
Phase 2
Interventional Study
Cleft Lip
Cleft Lip Scar
Prior Safety Data
This treatment has already been tested in at least one earlier human trial.
At a Glance
- Age
- 0 Days – 12 Months
- Sex
- Any
- Trial phase
- Phase 2
- Study type
- Interventional
- Purpose
- Prevention
- Participants needed
- 40 (estimated)
- Sponsor
- Children's National Research Institute · Other
Who this trial is looking for
This trial is looking for infants who need cleft lip repair surgery. Participants will receive either a Botox injection or a placebo during the surgery to see if it helps their scars heal better.
Are You a Good Fit for This Trial?
You may be able to join if
- I am an infant scheduled for cleft lip repair surgery.
- I am less than 12 months old at the time of surgery.
- My parent or legal guardian can give consent for me.
You may not be able to join if
- I am allergic to Botox or any related medications.
- I have a medical condition that may make participation unsafe.
- I have had treatment that could affect how the scar looks.
- I cannot complete the follow-up visits required for the study.
- The doctor thinks I have a condition that would interfere with the study.
Summarized in plain language from this trial's official eligibility criteria. The full criteria are further down this page — only the research team can confirm whether you qualify.
Think this trial could be right for you?
Answer three quick questions written from this study's own rules to see if you may qualify. No account needed to find out.
Check Your Eligibility
About This Trial
This study is investigating whether botulinum toxin type A (Botox) can improve scar appearance after cleft lip repair surgery. Cleft lip repair is commonly performed during infancy, but visible scarring can occur as the incision heals. Botox may reduce muscle movement around the surgical site during healing, which could decrease tension on the wound and improve scar formation.
In this study, infa…
Trial Locations
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Eligibility Criteria
Inclusion Criteria:
* Infants undergoing cleft lip repair
* Age less than 12 months at the time of surgery
* Parent or legal guardian able to provide informed consent
* Eligible to undergo study procedures and follow-up evaluations
Exclusion Criteria:
* Known hypersensitivity or contraindication …
Contacts