A prospective, randomized, comparative, clinical studyto assess the safety and performance of Cross-linked Hyaluronic Acid- Dermalfiller in people with all skin types, who need Lip Enhancement, Cheek boneAugmentation and Nasolabial fold improvement

Biotech Vision Care Pvt Ltd0 个研究点目标入组 0 人开始时间: 待定最近更新: 2021年11月24日

试验速览

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•1. The patient must be >= 18 and <= 75 years of age.
•2. The patient is willing and able to comply with the study protocol.
•3. The patient is seeking soft tissue augmentation treatment on the face.
•4. The patient needing Cheek bone Augmentation will be enrolled in arm 1 of the
•5. The patient with deep depression of the Nasolabial folds will be enrolled in arm
•2 of the trial.
•6. The patient needing Lip Enhancement will be enrolled in arm 3 of the trial.
•7. The patient agrees to follow-up examinations out to 6 months post final
•8. The patient has a pre-treatment Wrinkle Severity Score (WSS) >= 2 for bilateral
•NLF to be treated

•1. At risk in term of precautions, warnings and contra-indication referred in the
•package insert of the study dermal fillers,
•2. Who underwent previous injection of permanent filler in the injected area.
•3. Pregnant/lactating women
•4. Participation in any other Clinical trial.
•5. Subjects who have an allergy to lidocaine, prilocaine or other amide-type
•6. Had a chemical peel at the NLF area within 4 weeks prior to study entry. In
•addition, subjects were restricted from undergoing chemical peels at the NLF
•area for the duration of the study.
•7. Had any treatment with BotoxÂ® injections:
•a) In the upper 1/3 of the face within 2 weeks prior to entry into the study, or
•b) In the lower 2/3 of the face within 24 weeks prior to entry. In addition,
•subjects were restricted from receiving Botox injections in the face for the
•duration of the study.
•8. Had a history of hypo- or hyperpigmentation of the skin.
•9. Tolerance to antibiotics or corticosteroids.
•10. Had any infection, unhealed wound, or active inflammatory process (e.g., skin
•eruptions such as cysts, pimples, rashes, or hives) at the injection site(s).
•11. A known history of keloids or bleeding disorders.
•12. Leukoderma (Vitiligo) or a family history of leukoderma or other pigmentary
•13. Patient on Medication with blood thinners.
•14. Severe physical, neurological or mental disease.
•15. Excessive facial hair that might interfere with the study of the wrinkle
•assessments.

发起方

Biotech Vision Care Pvt Ltd