Evaluation of the ReAura skin rejuvenation device for daily self-administred full face treatment of fine lines

Evaluation of the ReAura skin rejuvenation device for daily self-administred full face treatment of fine lines - KO-05-PV

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

NL-OMON

Registry ID

NL-OMON35657

Enrollment

Registered

2011-10-07

Start date

2011-10-11

Completion date

Unknown

Last updated

2024-04-29

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

Conditions

Huidveroudering fine lines Skin rejuvenation

Interventions

All subjects will treat the face with RéAuratm, a handheld, laser-based, skin rejuvenation device, during 30 daily sessions and additionally bi weekly during two months of maintenance. Per treatment

Eligibility

Age

18 Years to 99 Years

Inclusion criteria

Inclusion criteria: Age 30-65y, mild to moderate fine lines in the face

Exclusion criteria

Exclusion criteria: Decreased wound healing

Design outcomes

Primary

Measure	Time frame
> 60% of users >= 1 FWS improvement at 1 week follow-up (after 30 day treatment)	—

Secondary

Measure	Time frame
Objective endpoints > 60% of users >= 1 FWS improvement after 2 month maintenance > 81% of users at least mild improvement in fine lines (quartile improvement scale) > 86% of users at least mild improvement in skin texture (quartile improvement scale) Subjective endpoints: > 70% of users at least mild improvement in fine lines > 83% of users at least mild improvement in skin texture > 86% of users at least mild improvement in overall appearance > 84% of users at least mild improvement in even skin tone	—

Measure

Time frame

Objective endpoints > 60% of users >= 1 FWS improvement after 2 month maintenance > 81% of users at least mild improvement in fine lines (quartile improvement scale) > 86% of users at least mild improvement in skin texture (quartile improvement scale) Subjective endpoints: > 70% of users at least mild improvement in fine lines > 83% of users at least mild improvement in skin texture > 86% of users at least mild improvement in overall appearance > 84% of users at least mild improvement in even skin tone

—

Countries

Netherlands

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)