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Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up baseline versus week 4
Awards & highlights
No Placebo-Only Group
Summary
This trial will study the effects of Botox on sebum production in 34 female participants. The study will be double blind, meaning neither the researchers nor the participants will know who is receiving the Botox treatment or the placebo.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ baseline versus week 4
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~baseline versus week 4
Treatment Details
Study Objectives
Study objectives can provide a clearer picture of what you can expect from a treatment.Primary study objectives
Skin quality assessment
Awards & Highlights
No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.
Trial Design
2Treatment groups
Experimental Treatment
Active Control
Group I: Group 2Experimental Treatment1 Intervention
Subjects will receive the traditional, deep injection technique, in addition to a superficial intradermal injection technique, which uses micro-aliquots of toxin. The superficial technique will deposit 0.1 units of toxin at 5mm intervals, at the level of the deep dermis.
Group II: Group 1Active Control1 Intervention
Subjects will receive BTX in the glabella and forehead regions, using a traditional injection technique commonly utilized in aesthetic medicine. The traditional injection technique will deposit the neurotoxin into the targeted muscles; with up to 24 units being injected into the forehead and 20 units in the glabella.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Botox Cosmetic
2021
N/A
~40
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Who is running the clinical trial?
Andreas NikolisLead Sponsor
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