Phase 3
N=26
Lateral Canthal Rhytides With Medium Depth Chemical Peel With or Without Pretreatment With Botulinum Toxin A
Wrinkles
Bottom Line
View on ClinicalTrials.gov: NCT01586819 ↗Enrolled (actual)
26
Serious AEs
0.0%
Results posted
Sep 2017
Primary outcome: Primary: Posttreament Results of Chemical Peel if Botox A is Added as Pre-treatment — 1; 2 Units on a wrinkle severity scale — p=.002
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 3
- Interventions
- Botulinum Toxin (Drug); Chemical Peel Only (Procedure)
- Age
- Adult, Older Adult · 30+ yrs
- Sex
- All
- Sponsor
- Loyola University
- Primary completion
- May 2013
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Posttreament Results of Chemical Peel if Botox A is Added as Pre-treatment |
1; 2 | .002 sig |
| PRIMARY Change From Pre- to Post-treatment Scores of Chemical Peel if Botox A is Added as Pre-treatment |
2; 1 | .001 sig |
Summary
This study is being done to find out if the use of botulinum toxin prior to a medium strength combination chemical peel (Jessner's peel followed by 35% Trichloroacetic acid peel) will improve the appearance of crow's feet wrinkles when compared to a chemical peel alone. Botulinum toxin type A is a purified substance, derived from a bacteria that block muscular nerve signals. Jessner's Peel, a combination of resorcinol (14g), salicylic acid (14g), and lactic acid (85%) in ethanol (95%), is a superficial chemical peel. These two products/procedures have been FDA approved to improve the appearance of facial wrinkles.
Eligibility Criteria
Inclusion Criteria
- Age 30 to 75 years old
- In good health
- Has static and dynamic lateral canthal wrinkles ("crow's feet")
- Has the willingness and the ability to understand and provide informed consent and communicate with the investigator
Exclusion Criteria
- Pregnant or lactating
- Has received the following treatments:
- botulinum toxin injections in the past 6 months
- ablative laser procedure in the past 6 months
- radiofrequency device treatment in the past 6 months
- ultrasound device treatment in the past 6 months
- medium to deep chemical peel in the past 6 months
- temporary soft tissue augmentation material in the past year
- semi-permanent soft tissue augmentation material in the past 2 years
- permanent soft tissue augmentation material
- Is planning to receive within the next 3 months, any cosmetic procedure (such as any chemical peels, botulinum toxin injections, ablative or non-ablative laser procedures, filler injections, radiofrequency procedures, dermabrasion, ultrasound and face lifting procedures)
- Has an active infection on their face (excluding mild acne
- Has a history of neuromuscular disorders
- Has an allergy to albumin
- Has an allergy to Aquaphor AND petroleum jelly
- Has a history of bleeding disorders
- Is unable to understand the protocol or to give informed consent
- Has a mental illness
Data sourced from ClinicalTrials.gov (NCT01586819). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.