Completed
Pilot Clinical Trial Investigating the Effect of Cutaneous Cooling on Sebum Production
What is being tested
The Zeltiq System
Device
Who is being recruted
Sebaceous Gland Diseases+2
+ Skin Diseases
+ Skin and Connective Tissue Diseases
From 18 to 25 Years
+18 Eligibility Criteria
How is the trial designed
Other Study
Interventional
Study Start: August 2012
Summary
Principal SponsorZeltiq Aesthetics
Last updated: September 18, 2025
Sourced from a government-validated database.Claim as a partner
Study start date: August 16, 2012
Actual date on which the first participant was enrolled.The study evaluated the use of the Zeltiq System to reduce sebum production on the upper back.
Principal SponsorZeltiq Aesthetics
Last updated: September 18, 2025
Sourced from a government-validated database.Claim as a partner
Protocol
This section provides details of the study plan, including how the study is designed and what the study is measuring.Design Details
11 patients to be enrolled
Total number of participants that the clinical trial aims to recruit.Other Study
Some studies explore topics that don't fall into a specific category. These might include innovative research, new technologies, or emerging healthcare areas.
Eligibility
Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.Conditions
Criteria
Male
Biological sex of participants that are eligible to enroll.From 18 to 25 Years
Range of ages for which participants are eligible to join.Healthy volunteers allowed
If individuals who are healthy and do not have the condition being studied can participate.Conditions
Pathology
Sebaceous Gland DiseasesSkin DiseasesSkin and Connective Tissue DiseasesAcneiform EruptionsAcne Vulgaris
Criteria
8 inclusion criteria required to participate
Informed consent agreement signed by the subject
Male subjects > 18 years of age and < 25 years of age
Subject has Fitzpatrick Skin Phototypes I-III (see Appendix A)
Subject has an average sebum output on their upper back of at least 20, as measured by the sebumeter
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10 exclusion criteria prevent from participating
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
Presence of suntan in the area to be treated
Subject has a history of isotretinoin use
Subject has a history of keloid formation
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Study Plan
Find out more about all the medication administered in this study, their detailed description and what they involve.Treatment Groups
Study Objectives
One single intervention group is designated in this study
This study does not include a placebo group
Treatment Groups
Group I
ExperimentalSubjects enrolled in the study were treated on the back with the Zeltiq System.
Two sites on the upper back were selected as test sites and 1 site was used as a control.
Study Objectives
Primary Objectives
Secondary Objectives
Study Centers
These are the hospitals, clinics, or research facilities where the trial is being conducted. You can find the location closest to you and its status.This study has 1 location
Massachusetts General Hospital
Boston, United StatesOpen Massachusetts General Hospital in Google MapsCompletedOne Study Center