A study to assess the safety and efficacy of Poly-L-lactic acid dermal fillers in the treatment of facial ageing
- Conditions
- Facial ageingNot Applicable
- Registration Number
- ISRCTN66942709
- Lead Sponsor
- Sinclair Pharma
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Ongoing
- Sex
- All
- Target Recruitment
- 142
1. Male or female subjects between the ages of 25 and 75 years of age
2. Subject seeking an aesthetic improvement of her/his face with a poly-L-lactic acid dermal filler product
3. Any one or more of the following clinician-assessed criteria:
3.1. Mild to significant volume deficit in the mid-face (score of 2-4 on the designated photographic assessment scale)
3.2. Moderate to severe nasolabial folds (3-4 on the designated photographic assessment scale)
3.3. Mild to moderate jawline ptosis as assessed (score of 1-2 on the designated photographic assessment scale)
3.4. Minimal to severe temporal hollowing (2-4 on the designated photographic assessment scale)
4. Subject having given freely and expressly his/her informed consent
5. Subject willing to have photographs of the face taken and who is willing to provide approval for the use of their study data including photographs
6. Subjects must be willing and able to comply with protocol requirements, instructions, and protocol-stated restrictions and be likely to complete the study as planned.
7. Women of childbearing potential should be using a medically accepted contraceptive regimen for at least 12 weeks prior to study entry and over the entire study duration
8. Subjects willing to commit to having no further facial aesthetic treatments that will affect the appearance of the study treatment areas for the duration of the study period, including follow-up
1. Subjects who, in the months prior to their enrolment assessment have undergone any of the following treatments in the facial region to be treated:
1.1. 3 months prior:
1.1.1. Mesotherapy
1.1.2. Resurfacing (e.g., laser, radio frequency, dermabrasion, or chemical peel)
1.2. 6 months prior:
1.2.1 Temporary filler (e.g., Ha, CaHA, PCL)
1.2.2. Neuromodulator injections
1.3. 12 months prior:
1.3.1. Cosmetic facial plastic surgery (other than rhinoplasty)
1.3.2. Tissue grafting (e.g., fat injections)
1.3.3. Tissue lifting implants (e.g., threads, barbs) or other implants
1.3.4. Augmentation with semi-permanent filler (e.g., PLLA)
2. Subjects who have received treatment with a permanent, silicone or PMMA filler in the region of the face to be treated
3. Subjects who have received any other facial aesthetic procedures that will affect the appearance of the region of the face to be treated, at any time during the study period
4. Pregnant women or nursing women or women planning to become pregnant during the study
5. Subject, who is likely to become pregnant during the course of the study, who is not using or has changed or started their medically accepted contraceptive regimen or any other hormonal treatment during the 12 weeks prior to study entry
6. Subject with a known history of, or susceptibility to, keloid formation or hypertrophic scarring
7. 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
8. Subject with scar(s), mole(s), tattoos, permanent make-up, facial hair, or anything in the studied zones which might interfere with the evaluation
9. Subject with a known history of or suffering from autoimmune disease and/or immune deficiency unless stable and controlled by medication and will not interfere, at the interpretation of the investigator, with the study objectives in terms of efficacy and safety
10. Subject with porphyria
11. Subject with a known history of streptococcal disease (recurrent throat infections, acute rheumatic fever with or without cardiac involvement)
12. Subject with a known history of precancerous lesions/skin malignancies
13. Subject with a known history of severe allergy or anaphylactic shock
14. Subject with a known bleeding disorder or is receiving medication that will likely increase the risk of bleeding during treatment
15. Subject using medication such as aspirin, nonsteroidal anti-inflammatory drugs (NSAIDs), antiplatelet agents, thrombolytics or anticoagulants within one week prior to injection visit and 1 month after treatment
16. Subject suffering from an active disease such as inflammation, infection, tumours, psoriasis, allergic edema, inflammatory and/or infectious cutaneous disorders (herpes, acne, rosacea...) on the face within 6 months of the study entry
17. Any medication which may interfere, at the interpretation of the investigator, with the study objectives in terms of efficacy and safety.
18. Subject suffering from a severe or prog
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method