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Defensins
enhanced DefenAge 8-in-1 BioSerum for Crow's Feet
Phase 3
Waitlist Available
Led By Sabrina G Fabi, MD
Research Sponsored by Goldman, Butterwick, Fitzpatrick and Groff
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Having no uterus
Barrier method used with an additional form of contraception (e.g., sponge, spermicide or condom)
Timeline
Screening 3 weeks
Treatment Varies
Follow Up day 30, 60 and 90
Awards & highlights
Study Summary
This trial will test the effectiveness of a new wrinkle serum that contains a higher concentration of defensins.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
You are 30 years of age or older.
Select...
Subjects with moderate to severe periorbital wrinkles (at least a grade II in wrinkles and score of 4 in elastosis on the Fitzpatrick-Goldman wrinkle scale) are eligible for the treatment.
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You have not had menses for at least 12 months.
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Use of oral contraceptive pill, injection, implant, patch, vaginal ring, intrauterine device.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ day 30, 60 and 90
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~day 30, 60 and 90
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Asses the change of Percent of improvement at different time points
Clinician evaluator assessment of change using Fitzpatrick-Goldman Classification of Wrinkling and Degree of Elastosis Scale
Secondary outcome measures
Investigator assessment of tolerability of study drug including erythema, burning/stinging, dryness, peeling (desquamation), and tenderness
Investigator-assessed Global Aesthetic Improvement Score (I-GAIS)
Patient questionnaire
+1 moreTrial Design
1Treatment groups
Experimental Treatment
Group I: DefenAge 8-in-1 BioSerum supplemented with enhanced concentration of defensinsExperimental Treatment1 Intervention
Enrolled subjects will all receive enhanced DefenAge 8-in-1 BioSerum to be applied on the face including periorbital area.
Find a Location
Who is running the clinical trial?
Goldman, Butterwick, Fitzpatrick and GroffLead Sponsor
28 Previous Clinical Trials
570 Total Patients Enrolled
MediCell Technologies, LLCUNKNOWN
Advanced DermatologyOTHER
2 Previous Clinical Trials
61 Total Patients Enrolled
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Has the FDA cleared Defenage 8-in-1 BioSerum for use?
"There is both efficacy and safety data available for review as this is a Phase 3 trial, so our team has rated the DefenAge 8-in-1 BioSerum as a 3."
Answered by AI
How many individuals have been chosen to participate in this clinical trial?
"That is correct. The clinicaltrials.gov website says that this research is looking for 20 people to enroll at a single location. The trial was first advertised on October 11th, 2021 and was updated on October 26th, 2021."
Answered by AI
Who else is applying?
What state do they live in?
Texas
California
How old are they?
65+
18 - 65
What site did they apply to?
West Dermatology Research Center/Cosmetic Laser Dermatology
What portion of applicants met pre-screening criteria?
Met criteria
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