Status:
COMPLETED
Assess the Impact of Lip Rejuvenation on Projected First Impressions and Mood Perceptions
Lead Sponsor:
DeNova Research
Conditions:
Lip Rejuvenation
Eligibility:
All Genders
21+ years
Phase:
NA
Brief Summary
20 subjects with mild to severe oral commissures or none to severe perioral lines will be enrolled and injected with Restylane® Silk. Photographs will be taken prior to and 14 days after Optimal Cosme...
Eligibility Criteria
Inclusion
- Subject is an adult of at least 21 years of age;
- Subject has mild to severe oral commissures or none to severe perioral lines, as assessed by the treating investigator;
- Subject is willing and able to provide written informed consent prior to the performance of any study related procedure;
- Subject is willing and able to comply with the protocol requirements; and
- Subject is willing and able to provide written photo consent and adhere to the photography and video procedures such as removal of jewelry and makeup
Exclusion
- Subjects who have received lip filler treatments in the past 12 months or neurotoxin injections in the past 6 months;
- Subjects who plan to undergo neurotoxin treatments, ablative skin treatments, facial cosmetic surgery, or other injectable filler treatments during the course of the study;
- Subjects with a known allergy or sensitivity to any component of the study ingredients;
- Subjects with a history of bleeding disorders;
- Female subjects who are pregnant or nursing as well as those who are of childbearing potential but do not employ adequate birth control methods;
- Subjects with severe allergies manifested by a history of anaphylaxis or presence of multiple severe allergies;
- Subjects with previous history of sensitivity to amide type local anesthetics;
- Current history of chronic drug or alcohol abuse;
- Concurrent therapy that, in the investigator's opinion, would interfere with the evaluation of the safety or efficacy of the study product;
- Subjects who, in the investigator's opinion, have a history of poor cooperation, non-compliance with medical treatment, or unreliability; and
- Enrollment in any active study involving the use of investigational devices or drugs.
Key Trial Info
Start Date :
September 1 2015
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
June 16 2017
Estimated Enrollment :
20 Patients enrolled
Trial Details
Trial ID
NCT03241862
Start Date
September 1 2015
End Date
June 16 2017
Last Update
November 4 2020
Active Locations (1)
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1
DeNova Research
Chicago, Illinois, United States, 60611