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Clinical Trials/CTRI/2019/03/018015
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

Virchow Biotech Private Limited0 sites0 target enrollmentTBD

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.

Registry
who.int
Start Date
TBD
End Date
TBD
Last Updated
4 years ago
Study Type
Pms

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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