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.

Age range18 Years – 25 Years

SexMALE

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

✓. 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

✕. 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
✕. Presence of suntan in the area to be treated
✕. Subject is immunosuppressed
✕. Subject is unable to comply with treatment, home care or follow-up visits
✕. Subject has a history of vitiligo
✕. Subject has a history of keloid formation

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

NCT IDNCT01686841

SponsorZeltiq Aesthetics

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2013-04-29

Results submitted2021-11-04

Who can participate