CTRI/2019/03/018015
Not yet recruiting
未知
Comparative study on the Safety and Efficacy of Sodium hyaluronate 2% (Pen Injector) and Restylane Vital (PFS)for skin rejuvenation of dorsal handa
Overview
- Phase
- 未知
- Intervention
- Not specified
- Conditions
- Not specified
- Sponsor
- Virchow Biotech Private Limited
- Status
- Not yet recruiting
- Last Updated
- 4 years ago
Overview
Brief Summary
No summary available.
Investigators
Eligibility Criteria
Inclusion Criteria
- •1\.Signed informed consent obtained
- •2\.Male or female subjects 25\-60 years of age, inclusive.
- •3\.Visible signs of skin aging in the hands (e.g. reduced skin elasticity, reduced turgor, actinic elastosis, smaller and larger wrinkles) according to the Investigators opinion.
- •4\.Subjects must be cooperative and willing to comply with the instructions and procedures.
Exclusion Criteria
- •1\.Active skin disease, inflammation or related conditions, such as infection, perioral dermatitis, seborrheic eczema and rosacea in the face, hands or décolletage.
- •2\.History of or active collagenosis (e.g. systemic lupus, erythematosis, rheumatic arthritis, skin or systemic sclerosis).
- •3\.Previous hypersensitivity to hyaluronic acid.
- •4\.Concomitant therapy with thrombolytics or anticoagulants, or have taken inhibitors of platelet aggregation, within 2 weeks before the baseline visit.
- •5\.History of cancerous or pre\-cancerous lesions in the face, hands and décolletage.
- •6\.Previous tissue augmenting therapy with non\-permanent filler or treatment with botulinum toxin, aesthetic surgical therapy, laser treatment, mesotherapy, or any form of peeling in the face, hands or décolletage within 12 months prior to the baseline visit.
- •7\.Use of injectable revitalization preparations (e.g. Hyal System®, Restylane Vital, Hyfil) within 12 months prior to the baseline visit.
- •8\.Use of retinoic acid within 6 months prior to the baseline visit.
- •9\.Previous or concomitant treatment with chemotherapy, immunosuppressive agents or corticoids.
- •10\.History of treatment with permanent filling materials.
Outcomes
Primary Outcomes
Not specified
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