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临床试验/CTRI/2019/03/018015
CTRI/2019/03/018015尚未招募未知

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 个研究点目标入组 0 人开始时间: 待定最近更新:

试验速览

阶段
未知
状态
尚未招募

研究概览

简要总结

暂无简介。

研究设计

研究类型
Pms

入排标准

入选标准

  • 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.

排除标准

  • 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.
  • 11.Pregnancy or breast feeding woman or woman of childbearing potential not practicing adequate contraception.
  • 12.Participation in any other clinical study within 30 days prior to the baseline visit or plan to participate in another clinical study during this study period.
  • 13.Unrealistic expectation with regard to the esthetic results of the treatment.
  • 14.Alcohol or drug or medication abuse;
  • 15.Protocol non-compliant subjects;
  • 16.Any significant laboratory findings

研究者

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