CompletedNot Applicable

A Pilot Clinical Trial Investigating the Effect of Cutaneous Cooling on Sebum Production

United States11 participantsStarted 2012-08-16

Plain-language summary

To evaluate the safety and feasibility of reducing human sebum production using the ZELTIQ System.

Who can participate

Age range

18 Years – 25 Years

Sex

MALE

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

. Male subjects \>18 years of age and \<25 years of age.
. Subject has an average sebum output on their upper back of at least 20, as measured by the sebumeter
. Subject has Fitzpatrick Skin Phototypes I-III (see Appendix A)
. Willingness to participate in the study
. Willingness to receive EXPERIMENTAL treatment
. Informed consent agreement signed by the subject
. Willingness to follow the treatment schedule and post treatment care requirements
. Willingness to not use topical or systemic retinoids or antibiotics during the course of the treatment

Exclusion criteria

. Subject has a history of isotretinoin use
. Subject has an infection or other dermatologic condition (aside from acne) in the area to be treated
. Subject has known cold sensitivity disorders including Raynaud's phenomena, cold urticaria, cryoglobulinemia, and cold induced hemoglobinuria

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

Percent Change in Sebum Production in Treated Sites as Compared to Baseline Using Sebutape Measurements.

Timeframe: Baseline and 2 weeks post-treatment

The Number of Unanticipated Adverse Device Effects (UADEs) Reported During the Study Period Will be Tabulated.

Timeframe: Time of enrollment through final 4-week follow-up visit

Trial details

NCT IDNCT01686841

SponsorZeltiq Aesthetics

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2013-04-29

Results submitted2021-11-04

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