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Safety and effectiveness assessment of injectable suspension of Inshape x Radiance plus for the treatment of the back of hand wrinkles

Safety and effectiveness assessment of injectable suspension of Inshape x Radiance plus (Nano Darou Pajuhan Pardis)for the treatment of the back of hand wrinkles.”

Status
Recruiting
Phases
Phase 2
Study type
Interventional
Source
IRCT
Registry ID
IRCT20150101020514N31
Enrollment
15
Registered
2024-08-14
Start date
2024-08-10
Completion date
Unknown
Last updated
2024-08-26

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

The back of hand wrinkles. Changes in skin texture

Interventions

Intervention group: The participants in this study will receive a ready-to-inject syringe of Inship X Radiance (Calcium Hydroxyl Apatite + Lidocaine) produced by Nano Darou Pajuhan Pardis subcutaneou

Sponsors

Nano Darou Pajouhan Pardis Company
Lead Sponsor

Eligibility

Sex/Gender
All
Age
30 Years to No maximum

Inclusion criteria

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

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

Design outcomes

Primary

MeasureTime frame
Percentage of subjects with improvement in back of hand wrinkles. Timepoint: 30 days after intervention. Method of measurement: Merz Hand Grading Scale (MHGS).

Secondary

MeasureTime frame
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).

Countries

Iran (Islamic Republic of)

Contacts

Public ContactAniseh Samadi

Tehran University of Medical Sciences

aniseh_samadi@yahoo.com+98 21 8896 0880

Outcome results

None listed

Source: IRCT (via WHO ICTRP) · Data processed: Feb 4, 2026