ISRCTN72858148
Active, Not Recruiting
N/A
Assessment of the safety and effectiveness of the use of Perfectha® Derm Lidocaine and Perfectha® Deep Lidocaine in the treatment of lips
Sinclair Pharma0 sites68 target enrollmentNovember 17, 2022
Overview
- Phase
- N/A
- Intervention
- Not specified
- Conditions
- For Perfectha® Derm Lidocaine: very thin to thin lip volume and with lip contour somewhat well-defined to poorly defined
- Sponsor
- Sinclair Pharma
- Enrollment
- 68
- Status
- Active, Not Recruiting
- Last Updated
- 3 years ago
Overview
Brief Summary
No summary available.
Investigators
Eligibility Criteria
Inclusion Criteria
- •1\. Sex: female or male
- •2\. Age: between 18 and 65 years
- •3\.1\. For group 1: subject seeking treatment for lip volume and for lip contour redefinition
- •3\.2\. For group 2: subject seeking treatment for lip volume
- •4\.1\. For group 1: subject with very thin to thin lip volume (grade 1 to 2 for superior and/or inferior lip on the Rossi scale) and with lip contour somewhat well\-defined to poorly defined (grade 2 or 3 on the Draelos vermilion border scale)
- •4\.2\. For group 2: subject with thin to moderate lip volume (grade 2 to 3 for superior and/or inferior lip on the Rossi scale)
- •5\. Subject having given freely and expressly his/her informed consent and data privacy consent
- •6\. Subject willing to have photographs of the face taken and who are willing to provide approval for the use of their study data and anonymized photographs in published literature
- •7\. Subject willing and able to comply with study follow\-up procedures and schedule
- •8\. Subject affiliated with a health social security system
Exclusion Criteria
- •1\. Pregnant or nursing woman or planning a pregnancy during the study
- •2\. Subject who had been deprived of their freedom by administrative or legal decision or who is under guardianship
- •3\. Subject in a social or sanitary establishment
- •4\. Subject is an employee of the investigational site, the CRO or the study sponsor
- •5\. Subject with scar(s), mole(s) or anything on the studied zones which might interfere with the evaluation (tattoo, permanent make\-up)
- •6\. Subject with major dental problems or major dental procedure within 6 weeks before screening visit or planned during the study
- •7\. Subject not eligible for scientific reasons at the interpretation of the investigator
- •8\. Subject under epidemiologic surveillance/in quarantine linked to the COVID\-19 pandemic
- •9\. Subject having a medical history which may interfere, at the interpretation of the investigator, with the study objectives in terms of effectiveness and safety
- •10\. Subject suffering from a severe or progressive disease or any other pathology that may interfere with the evaluation of the study result and/or subject safety
Outcomes
Primary Outcomes
Not specified
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