CompletedNot Applicable

Efficacy Trial for the Reduction of Glabellar Lines

United States78 participantsStarted 2015-02

Plain-language summary

The purpose of this study is to evaluate the ability of the Serene RF System to effectively improve the appearance of dynamic glabellar lines and sustain the effect for a minimum of 3 months.

Who can participate

Age range

18 Years – 70 Years

Sex

ALL

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

. Glabellar lines rating of at least two per the Merz Scale
. Written informed consent
. Understands and accepts the following obligations during the follow-up period (minimum of three months and up to one year)
. available for the 3 day phone call and present for each follow-up visit;
. receive NO other facial procedures in the upper face for a minimum of three months and up to one year after the RF procedure;
. make NO changes to the eyebrows for a minimum of three months after the RF procedure.

Exclusion criteria

. Injection of botulinum toxin to the upper face within the previous four months
. Use of fillers in the upper face within the previous twelve months
. Use of prescription treatments (e.g., Renova, Retin-A, micro-dermabrasion, chemical peels) on the upper face, in the area between the eyebrows where frown lines occur, within the previous four weeks or plans to use these treatments during the study
. Facial or skin conditions that could interfere with treatment or confound results (e.g., signs or symptoms of eyebrow or eyelid ptosis, facial nerve palsy, scarring, infection)

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

The reduction of glabellar lines

Timeframe: 3 months

Trial details

NCT IDNCT02466178

SponsorSerene Medical Inc

Sponsor typeINDUSTRY

Study typeOBSERVATIONAL

Primary completion2016-04

View on ClinicalTrials.gov More Rhytids in the Glabellar Region trials