CompletedNot Applicable

Assessment Skin Quality and Efficacy of Dermal Line After Four Bipolar Radiofrequency Microneedling Treatments

United States13 participantsStarted 2022-01-14

Plain-language summary

This study intends to evaluate the safety and effectiveness of the InMode Morpheus8 System to treat facial and neck skin and assess its effect on skin quality and dermal lines. This device has been FDA cleared for full body subdermal adipose tissue remodeling.

Who can participate

Age range21 Years – 70 Years

SexALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion criteria

✓. Healthy male and female adults between ages 21-70 years of age.
✓. Presence of facial dermal lines and skin changes of the lower face associated with age or environmental exposure.
✓. Confirmed BMI ≤ 35.
✓. Subjects who can read, understand, and sign the Informed Consent Form.
✓. Subjects willing and able to comply with all study requirements.
✓. Fitzpatrick skin type I-VI.
✓. Minimum of 1 on the Lemperle Wrinkle Assessment Scale, Allergan Fine Line Scale and Allergan Skin Roughness Scale
✓. Subject is willing not to undergo any type of aesthetic procedure that could confound the study device treatment effects until he/she completes the study.

Exclusion criteria

✕. Active localized or systemic infections, that may alter wound healing.
✕. Immunocompromised subjects.
✕. Subjects with coagulation disorder.
✕. History of skin photosensitivity disorders, or use of photosensitizing drugs (e.g., tetracycline or sulfa drugs).
✕. Pregnant and/or lactating (All female volunteers will be advised about using birth control during the period of study).

What they're measuring

Change of Fine Lines and Wrinkles

Timeframe: Baseline, 3 Months and 6 Months

Change of Fine Lines

Timeframe: Baseline, 3 Months and 6 Months

Change of Skin Roughness

Timeframe: Baseline, 3 Months and 6 Months

Global Aesthetic Improvement Scale (GAIS)

Timeframe: 3 Months and 6 Months

Trial details

NCT IDNCT05085730

SponsorUniversity of Texas Southwestern Medical Center

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2022-12-22

Results submitted2023-06-05

View on ClinicalTrials.gov More Aging trials

Who can participate

Age range21 Years – 70 Years

SexALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion criteria

✓. Healthy male and female adults between ages 21-70 years of age.
✓. Presence of facial dermal lines and skin changes of the lower face associated with age or environmental exposure.
✓. Confirmed BMI ≤ 35.
✓. Subjects who can read, understand, and sign the Informed Consent Form.
✓. Subjects willing and able to comply with all study requirements.
✓. Fitzpatrick skin type I-VI.
✓. Minimum of 1 on the Lemperle Wrinkle Assessment Scale, Allergan Fine Line Scale and Allergan Skin Roughness Scale
✓. Subject is willing not to undergo any type of aesthetic procedure that could confound the study device treatment effects until he/she completes the study.

Exclusion criteria

✕. Active localized or systemic infections, that may alter wound healing.
✕. Immunocompromised subjects.
✕. Subjects with coagulation disorder.
✕. History of skin photosensitivity disorders, or use of photosensitizing drugs (e.g., tetracycline or sulfa drugs).
✕. Pregnant and/or lactating (All female volunteers will be advised about using birth control during the period of study).