AcneNCT01686841
A Pilot Clinical Trial Investigating the Effect of Cutaneous Cooling on Sebum Production
A study testing The Zeltiq System in people with Acne, run by Zeltiq Aesthetics at 1 site in United States.
Trial summary
To evaluate the safety and feasibility of reducing human sebum production using the ZELTIQ System. Read more about this study
- Who is it for?
- Ages 18 to 25 years, men onlyHealthy volunteers can take part
- Conditions the study is for
- Acne
- What is being tested?
- The Zeltiq System
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 11 participants
- Where
- 1 siteUnited States
- Study dates
- 16 Aug 2012to 31 Dec 2013
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 25 years
- Men only
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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
Who cannot join
- 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
Show all 10Show fewer
- 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.
Trial locations and contacts
1 site in 1 country.
United States1 site
Massachusetts General Hospital
Boston, Massachusetts, 02114
About this study
Official title: Pilot Clinical Trial Investigating the Effect of Cutaneous Cooling on Sebum Production
To evaluate the safety and feasibility of reducing human sebum production using the ZELTIQ System.
Read the detailed description
The study evaluated the use of the Zeltiq System to reduce sebum production on the upper back.
- Conditions
- Acne
- Being tested
- The Zeltiq System
- Keywords
- Cryolipolysis, Sebum
- Medical subject headings
- Acne Vulgaris
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
The Zeltiq SystemDevice
Also called Cryolipolysis
Non-invasive cooling is applied to the treatment area with a defined cooling rate and duration.
| Study group | Role | What they receive |
|---|---|---|
| Sebum Reduction | Experimental | Subjects 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. Receives: Device: The Zeltiq System |
What is being measured
The primary outcome is the main question the study is designed to answer.
Percent Change in Sebum Production in Treated Sites as Compared to Baseline Using Sebutape Measurements.
Reduction of sebum production as measured by Sebutape at 2 weeks post-treatment. A 30% reduction of sebum production in a treated site compared to baseline Sebutape measurements will be considered clinically meaningful. Sebutape is an adhesive patch that acts as a passive collector of sebum. The gradual displacement of air in the pores of the microporous film changes its appearance. The size of the transparent area is a measure of the amount of sebum collected. All Sebutape measurements were performed in duplicate and the average of the two measurements was used for analysis. Results indicate the mean difference in Sebutape scores from baseline to 2 weeks post-treatment.
Measured: Baseline and 2 weeks post-treatment
The Number of Unanticipated Adverse Device Effects (UADEs) Reported During the Study Period Will be Tabulated.
The frequency of unanticipated adverse device effects (UADEs) reported throughout the study will be tabulated. Acceptance criteria: zero incidence of UADEs.
Measured: Time of enrollment through final 4-week follow-up visit
Secondary outcomes (3)
The Number of Device- or Procedure-related Adverse Events Will be Tabulated.
Device- or procedure related adverse events will be tabulated; side effects of treatment will be assessed.
Measured: Time of enrollment through the final 4-week follow-up visit
Percent Change From Baseline of Sebum Production as Measured With Sebutape
Sebum production will be measured using Sebutape at 72 hours, 1 week, and 4 weeks post-treatment. Sebutape is an adhesive patch that acts as a passive collector of sebum. The gradual displacement of air in the pores of the microporous film changes its appearance. The size of the transparent area is a measure of the amount of sebum collected. Sebutape measurements were performed in duplicate. The average of the two readings was used for analysis. Results are expressed in µg/cm² and correspond to the total amount of sebum collected on the film.
Measured: 72 hours post-treatment, 1 week post-treatment and 4 weeks post-treatment
Number of Side Effect Events Post-treatment by Severity.
All treatment sites (-10C vs -15C) were assessed for expected side effects of erythema, edema/swelling and dysesthesia at specific time points of the study. Treatment sites were scored on a 0 to 3 scale, with 0 = absent, 1 =minor, 2 = moderate and 3 = severe.
Measured: Post-treatment to 4-week final follow-up visit
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Sep 2012 (estimated)
- Study start16 Aug 2012
- Primary completion29 Apr 2013
- Study completion31 Dec 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for AcneStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 11 participants (actual)
Sponsor and investigators
- Lead sponsor
- Zeltiq Aesthetics
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Rox Anderson, MD, Principal investigator, MGH
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01686841
- Sponsor's protocol ID
- ZA12-003
- Status last verified
- Aug 2025
- First submitted
- 12 Sep 2012
- Last updated
- 18 Sep 2025
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 18 Sep 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Pilot Clinical Trial Investigating the Effect of Cutaneous Cooling on Sebum Production
- ClinicalTrials.gov ID
- NCT01686841
- Acronym / sponsor ID
- ZA12-003
- Conditions
- Acne
- Keywords
- Cryolipolysis, Sebum
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 11 participants (actual)
- Lead sponsor
- Zeltiq AestheticsIndustry (pharma, biotech, devices)
- Study start
- 16 Aug 2012 (actual)
- Primary completion
- 29 Apr 2013 (actual)
- Study completion
- 31 Dec 2013 (actual)
- First posted
- 18 Sep 2012 (estimated)
- Results
- Posted 18 Sep 2025
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
To evaluate the safety and feasibility of reducing human sebum production using the ZELTIQ System.
Detailed description
The study evaluated the use of the Zeltiq System to reduce sebum production on the upper back.
Study design
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Sebum Reduction | Experimental | Device: The Zeltiq SystemSubjects 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. |
Who may qualify
- Ages
- 18 to 25 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (8 listed)
- 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
Key exclusion criteria (10 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| The Zeltiq SystemAlso: CryolipolysisNon-invasive cooling is applied to the treatment area with a defined cooling rate and duration. | Device | Sebum Reduction |
Primary outcome
Percent Change in Sebum Production in Treated Sites as Compared to Baseline Using Sebutape Measurements.
Time frame: Baseline and 2 weeks post-treatment
Reduction of sebum production as measured by Sebutape at 2 weeks post-treatment. A 30% reduction of sebum production in a treated site compared to baseline Sebutape measurements will be considered clinically meaningful. Sebutape is an adhesive patch that acts as a passive collector of sebum. The gradual displacement of air in the pores of the microporous film changes its appearance. The size of the transparent area is a measure of the amount of sebum collected. All Sebutape measurements were performed in duplicate and the average of the two measurements was used for analysis. Results indicate the mean difference in Sebutape scores from baseline to 2 weeks post-treatment.
The Number of Unanticipated Adverse Device Effects (UADEs) Reported During the Study Period Will be Tabulated.
Time frame: Time of enrollment through final 4-week follow-up visit
The frequency of unanticipated adverse device effects (UADEs) reported throughout the study will be tabulated. Acceptance criteria: zero incidence of UADEs.
3 secondary outcomes
The Number of Device- or Procedure-related Adverse Events Will be Tabulated.
Time frame: Time of enrollment through the final 4-week follow-up visit
Percent Change From Baseline of Sebum Production as Measured With Sebutape
Time frame: 72 hours post-treatment, 1 week post-treatment and 4 weeks post-treatment
Number of Side Effect Events Post-treatment by Severity.
Time frame: Post-treatment to 4-week final follow-up visit
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Sep 2025.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Rox Anderson, MD principal investigator
MGH
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing The Zeltiq System in people with Acne, run by Zeltiq Aesthetics at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 18 Sep 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 18 Sep 2025). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Percent Change in Sebum Production in Treated Sites as Compared to Baseline Using Sebutape Measurements. (time frame: Baseline and 2 weeks post-treatment). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Sep 2025.