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Investigating the safety and efficacy of fractional microneedle Sophia device, in rejuvenating facial skin

Investigating the safety and efficacy of fractional microneedle Sophia device, manufactured by Parnian Gostar Radiometer Company, in rejuvenating facial skin

Status
Recruiting
Phases
Phase 2
Study type
Interventional
Source
IRCT
Registry ID
IRCT20190210042676N26
Enrollment
21
Registered
2022-10-03
Start date
2022-10-23
Completion date
Unknown
Last updated
2022-11-21

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

Conditions

Skin ageing.

Interventions

Intervention group: 4 sessions of full face treatment with fractional microneedle Sophia device, manufactured by Parnian Gostar Radiometer Company as a complete pass on full face. The diameter of the

Sponsors

Parnian Gostar Radiometer Company
Lead Sponsor

Eligibility

Sex/Gender
All
Age
30 Years to 60 Years

Inclusion criteria

Inclusion criteria: Ages 30 to 60 People with facial skin wrinkles grade 2 and 3 based on Glogau scale and mild to moderate sagging (1 and 2) based on the Modified Fitzpatrick wrinkle criteria Signing the consent form for participation in the study

Exclusion criteria

Exclusion criteria: History of using any type of device filler, including silicone, fat, collagen, hyaluronic acid or artificial materials in the treatment area History of any type of cosmetic surgery during the last 3 years at the treatment area Use of Isotretinoin in the last 6 months

Design outcomes

Primary

MeasureTime frame
Facial skin wrinkle grading, using Glogau scale. Timepoint: Before intervention, 4 and 8 weeks after last treatment session. Method of measurement: An independent dermatologist perform evaluation and scoring with the help of full face photos based on the percentage of improvement in facial wrinkles, using scale 1 to 4 (1 = no wrinkle 2 = Wrinkles in motion 3 = Wrinkles at rest 4 = Only wrinkles) .

Secondary

MeasureTime frame
Skin thickness and density. Timepoint: Before intervention, 4 and 8 weeks after last treatment session. Method of measurement: Skin ultrasound.;Area and volume of nasolabial fold. Timepoint: Before intervention, 4 and 8 weeks after last treatment session. Method of measurement: VisioFace camera.

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