Safety and effectiveness assessment of injectable suspension of Inshape x Radiance plus for the treatment of the back of hand wrinkles
Phase 1
Recruiting
- Conditions
- The back of hand wrinkles.Changes in skin textureR23.4
- Registration Number
- IRCT20150101020514N31
- Lead Sponsor
- ano Darou Pajouhan Pardis Company
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Recruiting
- Sex
- All
- Target Recruitment
- 15
Inclusion Criteria
Age over 30 years
Moderate to very severe degree of hand wrinkles based on MHGS criteria
Agree to use safe methods of contraception.
Signing an informed consent form and agreed to follow up.
Exclusion Criteria
History of type 1 allergic reactions or anaphylaxis reaction
Pregnant or lactating or planning to become pregnant in the near future while studying
Allergy or sensitivity to lidocaine
Use of antiplatelet drugs during 72 hours before treatment and anticoagulant drugs during 2 weeks before or during treatment.
Any abnormality or history of surgery on the back of hand
Study & Design
- Study Type
- interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Percentage of subjects with improvement in back of hand wrinkles. Timepoint: 30 days after intervention. Method of measurement: Merz Hand Grading Scale (MHGS).
- Secondary Outcome Measures
Name Time Method Thickness and density of dermis. Timepoint: Before intervention and 6 months later. Method of measurement: Skin ultrasound.;Changes in the intensity of hand wrinkles. Timepoint: Before intervention and 6 months later. Method of measurement: Based on the GAIS (Global Aesthetic Improvement Scale).