A study to assess the safety and efficacy of hyaluronic acid dermal fillers in the treatment of facial aging

Not Applicable

• Conditions: Facial aging including temporal hollowing, mid face volume deficit, jawline ptosis and chin retrusion; Skin and Connective Tissue Diseases

• Registration Number: ISRCTN17960592
• Lead Sponsor: Sinclair Pharmaceuticals Limited

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2022-07-11
• Last Update Posted: 5 August 2022
• Study Completion: 2025-06-01

Recruitment & Eligibility

• Status: Ongoing
• Sex: All
• Target Recruitment: 168

Inclusion Criteria

1. Subjects must be generally healthy and 25-65 years of age at Screening Visit
2. Subjects who have:
2.1. Mild to significant volume deficit in the mid-face (score of 2-4 on the designated photographic assessment scale)
or
2.2. Mild to moderate jawline ptosis (score of 1-2 on the designated photographic assessment scale)
or
2.3. Minimal to severe chin retrusion (score of 1-3 on the designated photographic assessment scale)
or
2.4. Minimal to severe temporal hollowing (score if 2-4 on the designated photographic assessment scale)
3. Subjects who are willing to provide written informed consent, including approval for facial photographs to be taken.
4. Subjects willing to commit to having no further facial aesthetic treatments (see Table 2), that could affect the appearance of the facial treatment area, for the duration of the study period, including follow-up.
5. 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.
6. Female of childbearing potential should use a medically accepted contraceptive regimen since at least 12 weeks prior to study entry and during all the study.

Exclusion Criteria

Subjects meeting any of the following criteria will be excluded from the study:
1. Subjects who, in the twelve months prior to their enrolment assessment had undergone:
1.1. cosmetic facial plastic surgery (other than rhinoplasty),
1.2. tissue grafting (e.g., fat injections),
1.3. tissue lifting implants (e.g., threads, barbs) or other implants,
1.4. augmentation with any permanent or semi-permanent filler (e.g., silicone, PMMA, PLLA) or temporary filler (e.g., Ha, CaHA, PCL)
1.5. neuromodulator injections,
1.6. mesotherapy,
1.7. resurfacing in the mid-face (e.g., laser, radio frequency, dermabrasion, or chemical peel)
in the region of the face to be treated.
2. Subjects who have received other facial aesthetic procedures, that affects the appearance of the facial treatment, at any time during the study period.
3. Subjects currently enrolled in other clinical trials.
4. Subjects with facial hair as this could interfere with study evaluations.
5. Subject who had been deprived of their freedom by administrative or legal decision or who is under guardianship.
6. Subject is an employee of the aesthetic surgery department on the investigational site, the CRO or study sponsor.
7. Pregnant or nursing woman or planning a pregnancy during the study.
8. Subjects taking thrombolytics or anticoagulants.
9. Subjects with bleeding disorders.
10. Subjects with known hypersensitivities to hyaluronic acid, lidocaine, amide local anaesthetics or other components of the treatment.
11. Subjects with a history of severe allergy or anaphylactic shock.
12. Subjects with active (or a history of) autoimmune disease.
13. Subjects with porphyria.
14. Subjects with cutaneous disorders and areas affected by inflammation and/or infectious skin problems (e.g., acne, herpes) at or near the treatment site.
15. Subjects with a tendency to form keloids, hypertrophic scars or any other healing disorders.
16. Subject with known history of precancerous lesions/skin malignancies.
17. Subjects must avoid receiving COVID-19 vaccination for the 14 days before and following injection.

Study & Design

• Study Type: Interventional
• Study Design: Not specified