Status:
UNKNOWN
TEOSYAL RHA® 1 for Neck Lines, Perioral Lines and Smiling Lines
Lead Sponsor:
Teoxane SA
Conditions:
Skin Aging
Fine Lines of the Face and Neck
Eligibility:
All Genders
35-70 years
Phase:
NA
Brief Summary
Prospective, low-interventional, multicentric, open-labelled study to assess the performance and safety of skin beautification treatment by TEOSYAL RHA® 1 for fine lines in the neck, perioral region, ...
Eligibility Criteria
Inclusion
- Inclusion Criteria (General):
- Healthy adults, 35 to 70 years old seeking an improvement of their aesthetic appearance and beautification of their skin in 3 areas: perioral lines, smiling lines and neck lines.
- Subjects having given their informed consent.
- Subjects having wrinkle severity ranked as mild to moderate neck lines (grade 2 or grade 3 on the NLDS)
- Inclusion Criteria (Cohort) 4. Healthy adult having wrinkle severity in at least one of the two indications (50% for each of the following cohort): i. Moderate to severe perioral rhytids (grade 2 or grade 3 on the PR-SRS) ii. Moderate to severe smiling lines (grade 3 or grade 4 on the SLDS)
- Exclusion Criteria:
- Minor subjects
- Subjects who already had fillers and/or other skin quality treatment(s) in the 6 months preceding the study.
- Subjects undergoing or planning to undergo peeling treatment or laser/ultrasound-based treatment during the study or having had one of these treatments in the 6 months preceding the study.
- Subjects showing cutaneous disorders, inflammation or infection (acne, herpes, scars…) at the treatment site or near to this site.
- Subjects having a known hypersensibility to lidocaine and/or amide local anesthetic agents or hyaluronic acid, or with history of severe allergy or anaphylactic shock.
- Subjects with autoimmune or cardiac diseases and/or undergoing treatment for heart diseases (beta blockers).
- Subjects with hepatocellular insufficiency and/or undergoing treatment for liver disease.
- Subjects suffering from epilepsy or porphyria.
- Subjects with severe, ongoing and/or uncontrolled disease that may pose a health risk to the subject during the study and/or may have an impact on the study assessments.
- Subjects receiving or planning to receive high dose Vitamin E, aspirin, anti-inflammatories, or anti-coagulant during the week preceding each injection.
- Subjects receiving any long-term medical treatment or any treatment that, in the opinion of the clinical investigator, may interfere with test results or put the subject at undue risk.
- Subjects under guardianship/tutorship.
- Pregnant women or breastfeeding mother.
- Subjects participating to another research on human beings or being in an exclusion period for a previous study.
Exclusion
Key Trial Info
Start Date :
October 5 2021
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
May 31 2022
Estimated Enrollment :
67 Patients enrolled
Trial Details
Trial ID
NCT05349799
Start Date
October 5 2021
End Date
May 31 2022
Last Update
May 4 2022
Active Locations (4)
Enter a location and click search to find clinical trials sorted by distance.
1
Site 4
Alicante, Spain
2
Site 3
Barcelona, Spain
3
Site 1
Bilbao, Spain
4
Site 2
Madrid, Spain