N/A
N=11
A Pilot Clinical Trial Investigating the Effect of Cutaneous Cooling on Sebum Production
Acne
Bottom Line
View on ClinicalTrials.gov: NCT01686841 ↗Enrolled (actual)
11
Serious AEs
0.0%
Results posted
Sep 2025
Primary outcome: Primary: Percent Change in Sebum Production in Treated Sites as Compared to Baseline Using Sebutape Measurements. — -10.9; 6.9; 7.8; 45.0 Percent change from baseline
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- The Zeltiq System (Device)
- Age
- Adult · 18+ yrs
- Sex
- Male
- Sponsor
- Zeltiq Aesthetics
- Primary completion
- Apr 2013
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Percent Change in Sebum Production in Treated Sites as Compared to Baseline Using Sebutape Measurements. |
-10.9; 6.9; 7.8; 45.0 | — |
| PRIMARY The Number of Unanticipated Adverse Device Effects (UADEs) Reported During the Study Period Will be Tabulated. |
0; 0 | — |
| SECONDARY The Number of Device- or Procedure-related Adverse Events Will be Tabulated. |
0; 0 | — |
| SECONDARY Percent Change From Baseline of Sebum Production as Measured With Sebutape |
10.1; -9.7; 10.8; 26.7; -17.0; -4.2 | — |
| SECONDARY Number of Side Effect Events Post-treatment by Severity. |
0; 0; 6; 0; 0; 5 | — |
Summary
To evaluate the safety and feasibility of reducing human sebum production using the ZELTIQ System.
Eligibility Criteria
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
- 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
- Subject is currently enrolled in a clinical study of any other unapproved investigational drug or device.
- Any other condition or laboratory value that would, in the professional opinion of the investigator, potentially affect the subject's response or the integrity of the data or would pose an unacceptable risk to the subject.
Data sourced from ClinicalTrials.gov (NCT01686841). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.