Trial Outcomes & Findings for Feasibility Study To Collect Safety And Preliminary Efficacy Data For A Radiofrequency Microneedling Device (NCT NCT05254210)

NCT ID: NCT05254210

Last Updated: 2023-08-15

Results Overview

Photographs will be evaluated at the baseline and the 30 day follow up. The number of photographs with improvement (based on changes in the skin) from baseline to follow up images will be reported.

• Recruitment status: COMPLETED
• Study phase: NA
• Target enrollment: 10 participants
• Primary outcome timeframe: 30 day follow up
• Results posted on: 2023-08-15

Participant Flow

Participant milestones

Measure	Treatment With RF Device Subjects may receive up to 3 treatments with the RF device if they are willing to receive treatment for brow lifting and/or present with conditions such as, but not limited to; wrinkles, fine lines, crepey skin, acne scars, active acne, enlarged pores, loose skin on the face, neck and/or body RF Device (Potenza™): Test spots may be performed prior to the first treatment. Following test spots, for the treatment, the tip will be placed in contact with the skin. Parameters may be adjusted throughout the treatment and will determined by the Clinician.
Overall Study STARTED	10
Overall Study COMPLETED	8
Overall Study NOT COMPLETED	2

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Feasibility Study To Collect Safety And Preliminary Efficacy Data For A Radiofrequency Microneedling Device

Baseline characteristics by cohort

Measure	Treatment With RF Device n=10 Participants Subjects may receive up to 3 treatments with the RF device if they are willing to receive treatment for brow lifting and/or present with conditions such as, but not limited to; wrinkles, fine lines, crepey skin, acne scars, active acne, enlarged pores, loose skin on the face, neck and/or body RF Device (Potenza™): Test spots may be performed prior to the first treatment. Following test spots, for the treatment, the tip will be placed in contact with the skin. Parameters may be adjusted throughout the treatment and will determined by the Clinician.
Age, Categorical <=18 years	0 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	10 Participants n=5 Participants
Age, Categorical >=65 years	0 Participants n=5 Participants
Sex: Female, Male Female	9 Participants n=5 Participants
Sex: Female, Male Male	1 Participants n=5 Participants
Race/Ethnicity, Customized Caucasian/Persian	1 Participants n=5 Participants
Race/Ethnicity, Customized Caucasian	5 Participants n=5 Participants
Race/Ethnicity, Customized Brazilian/White	1 Participants n=5 Participants
Race/Ethnicity, Customized African American	2 Participants n=5 Participants
Race/Ethnicity, Customized Hispanic	1 Participants n=5 Participants
FitzPatrick Skin Type Fitzpatrick Skin Type I	6 Participants n=5 Participants
FitzPatrick Skin Type Fitzpatrick Skin Type II	2 Participants n=5 Participants
FitzPatrick Skin Type Fitzpatrick Skin Type III	0 Participants n=5 Participants
FitzPatrick Skin Type Fitzpatrick Skin Type IV	1 Participants n=5 Participants
FitzPatrick Skin Type Fitzpatrick Skin Type V	1 Participants n=5 Participants
FitzPatrick Skin Type Fitzpatrick Skin Type VI	0 Participants n=5 Participants

PRIMARY outcome

Timeframe: 30 day follow up

Population: Each subject had their after picture graded to determine if there was an improvement from the baseline.

Photographs will be evaluated at the baseline and the 30 day follow up. The number of photographs with improvement (based on changes in the skin) from baseline to follow up images will be reported.

Outcome measures

Measure

Treatment With RF Device n=8 photographs Subjects may receive up to 3 treatments with the RF device if they are willing to receive treatment for brow lifting and/or present with conditions such as, but not limited to; wrinkles, fine lines, crepey skin, acne scars, active acne, enlarged pores, loose skin on the face, neck and/or body RF Device (Potenza™): Test spots may be performed prior to the first treatment. Following test spots, for the treatment, the tip will be placed in contact with the skin. Parameters may be adjusted throughout the treatment and will determined by the Clinician.

Evaluation of Baseline Photographs Compared to Post Treatment Images

8 photographs graded as improved

Adverse Events

Treatment With RF Device

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Jamie Trimper

Cynosure

Phone: (978) 256-4200

Email: jamie.trimper@cynosure.com

Results disclosure agreements

• Principal investigator is a sponsor employee The PI cannot disclose confidential or proprietary information until after it becomes generally known or available to the public.
• Publication restrictions are in place

Restriction type: OTHER