Sofwave: Does a 3-Month Review Mean Retreatment?

A 3-month assessment in Sofwave research does not mean you need treatment every 3 months. At UH CELL Newsroom, we distinguish the timing of a follow-up assessment from the interval before another treatment. A study's assessment date should not automatically become your retreatment date.

What does 3 months mean in the study?

The 2021 Sofwave submission published by the US Food and Drug Administration (FDA) describes a 3-month follow-up in a manufacturer-conducted clinical trial. Eighty participants received treatment at five US study sites, and the study evaluated lifting of the eyebrows and tissue beneath the chin and on the neck. The 3-month visit included a clinician assessment of aesthetic improvement.

Here, 3 months was an observation point used to assess changes in study participants. It should not be interpreted as an FDA-recommended interval for repeat treatment. When a study assessed participants and when an individual may need another treatment are separate questions.

It does not establish when the effects end

The 3-month assessment in that submission also does not establish that treatment effects end at 3 months. Nor does it support the conclusion that repeating treatment every 3 months maintains those effects.

An assessment at a particular point does not, by itself, establish the full duration of an effect or the need for repeat treatment. Our point is not that a particular interval is right or wrong. It is that the interpretation should stay within the question the assessment actually addressed.

Ask separately about follow-up and retreatment

When preparing for a consultation, consider writing down two separate questions:

• When should changes after treatment be assessed?
• What would be the basis for recommending another treatment?

If you are given a date, ask whether it is a follow-up visit to review progress or a planned date for additional treatment. Understanding that distinction is more useful than treating the number “3 months” as a schedule on its own.

Skin responses and recovery times vary from person to person. Consult a medical professional for an accurate diagnosis and an individualized treatment plan.