Study to Evaluate the Efficacy of a Micro Coring Device for the Treatment of Scars of the Cytrellis Micro-Coring Device for the Treatment of Scars

ConditionScars
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorCytrellis Biosystems, Inc.

About this trial

A study to evaluate the safety and effectiveness of a micro coring device for the treatment of scars.

Eligibility criteria

This trial accepts healthy volunteers

Qualifiers

18 years of age or older

Fitzpatrick scale I-VI.

Any type of scar except for keloid scars

Able to provide written informed consent, understand and willing to comply with study related procedures and follow-ups.

Disqualifiers

Previous treatment of the scar tissue within last 6 months.

Silicone, fat, collagen or synthetic material in the treatment area.

History of keloid formation.

Active smokers (smoking more than ½ pack per day) or having quit smoking (½ pack per day) for less than 3 months.

Trial design

Design model

Single group

Treatments tested in this trial

  • MCD

    Device

    Micro coring skin removal with automated coring device

Treatment groups

30 Participants
are divided into 1 treatment group
Group A: Micro-coring of scars with MCDExperimental treatment 1 intervention

Trial outcomes

Primary outcomes

1

Assess level of aesthetic improvement using POSAS scale 6 months post last treatment

Assessing the improvement in the aesthetic appearance of the subject based on the POSAS scale comparing baseline to 6 months post last treatment. Parameters of vascularity, pigmentation, thickness, relief, and pliability, range from 1 to 10. normal skin =1; worst scar imaginable =10.

Time frame
6 months post last treatment
2

Assess level of aesthetic improvement using ASAS scale 6 months post last treatment

Assessing the improvement in the aesthetic appearance of the subject based on the Acne Scar scale comparing baseline to 6 months post last treatment. Grades range 0-4. Clear =0; Very Mild=1; Mild= 2; Moderate= 3; Severe= 4

Time frame
6 months post last treatment

Secondary outcomes

1

Assess safety profile by recording all adverse events reported during study

Adverse events will be recorded throughout the study

Time frame
6 months post last treatment

Other outcomes

Sponsors and contacts

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