Clinical Evaluation of Safety and Efficacy of the InMode RF Pro System With the Morpheus8 Applicator for the Treatment of Mild to Severe Inflammatory Acne Vulgaris

Status: Recruiting
Location: See all (4) locations...
Intervention Type: Device
Study Type: Interventional
Study Phase: Not Applicable
SUMMARY

The aim of this trial is to evaluate the safety and efficacy of the InMode RF Pro System with the Morpheus8 face tip (24 pins) applicator for the treatment of mild, moderate and severe, facial acne vulgaris

Eligibility
Participation Requirements
Sex: All
Minimum Age: 16
Healthy Volunteers: t
View:

• Subject is \>16 years of age

• General good health confirmed by medical history and examination of the treated area.

• Subjects with mild to severe Acne Vulgaris, defined as a baseline IGA (Investigator's Global Assessment) score of 2, 3 or 4 and 10-100 inflammatory lesions (papules or pustules).

• The patients should be willing to comply with the study procedure and schedule, including the follow up visits, and will refrain from using any other acne treatment methods during the entire study period.

• Willing to avoid sun/UV exposure for duration of the study unless using sunscreen.

• Willing to refrain from starting or changing hormonal contraception for duration of study.

• Subject understands and is willing to sign the informed consent to participate in the study. Parental (or other) guardians must provide consent for minors under the age of 18.

Locations
United States
Arizona
Avant Dermatology Aesthetics
RECRUITING
Oro Valley
Colorado
AboutSkin Research, LLC
ACTIVE_NOT_RECRUITING
Greenwood Village
New York
UnionDerm
ACTIVE_NOT_RECRUITING
New York
Texas
UT Southwestern Medical Center
RECRUITING
Dallas
Contact Information
Primary
Meital Matalon, MS
meital.matalon@inmodemd.com
9492588870
Backup
Maria Shusterman, RN
maria.shusterman@inmodemd.com
9492396522
Time Frame
Start Date: 2023-05-01
Estimated Completion Date: 2026-05-01
Participants
Target number of participants: 42
Treatments
Experimental: Device treatment
Treatment area will include affected areas over the entire face (presence of comedones, pustules, papules, nodules and cysts
Related Therapeutic Areas
Sponsors
Leads: InMode MD Ltd.

This content was sourced from clinicaltrials.gov