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Chill out acne: cooling device shows promise in reducing sebum

NCT ID NCT01686841

Symptom relief Sponsor: Zeltiq Aesthetics Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed This study
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 26, 2026 · Last updated Jun 26, 2026

Summary

This pilot study tested whether cooling the skin with a device (the Zeltiq System) could safely reduce sebum production in 11 young men with acne. The treatment was applied to the upper back, and sebum levels were measured before and after. The goal was to see if a 30% reduction in sebum was possible, which could help control acne. The study focused on safety and feasibility, not on curing acne.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
Zeltiq System (cryolipolysis device)
What this could lead to
If it works, this could lead to a non-invasive, drug-free way to reduce sebum and improve acne.
What could go wrong
This was a very small pilot study with only 11 men, so results may not apply to everyone. The cooling effect on sebum may be temporary or not strong enough to help acne.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Not a phased trial

Phase numbers describe drug development. The registry uses this when they do not apply, as it does for trials of devices, procedures or behaviour changes, and for observational studies.

Participants

11 people

The number who actually took part.

Started

Aug 2012

Finished

Dec 2013

Lead sponsor

A company

The lead sponsor is a pharmaceutical, biotech, or medical-device company.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 to 25 years

Sex

Male participants only

Healthy volunteers

Accepted

You do not need to have the condition being studied to take part.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

Inclusion criteria 1. Male subjects \>18 years of age and \<25 years of age. 2. Subject has an average sebum output on their upper back of at least 20, as measured by the sebumeter 3. Subject has Fitzpatrick Skin Phototypes I-III (see Appendix A) 4. Willingness to participate in the study 5. Willingness to receive EXPERIMENTAL treatment 6. Informed consent agreement signed by the subject 7. Willingness to follow the treatment schedule and post treatment care requirements 8. Willingness to not use topical or systemic retinoids or antibiotics during the course of the treatment Exclusion criteria 1. Subject has a history of isotretinoin use 2. Subject has an infection or other dermatologic condition (aside from acne) in the area to be treated 3. Subject has known cold sensitivity disorders including Raynaud's phenomena, cold urticaria, cryoglobulinemia, and cold induced hemoglobinuria 4. Presence of suntan in the area to be treated 5. Subject is immunosuppressed 6. Subject is unable to comply with treatment, home care or follow-up visits 7. Subject has a history of vitiligo 8. Subject has a history of keloid formation 9. Subject is currently enrolled in a clinical study of any other unapproved investigational drug or device. 10. 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.

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Conditions

The condition(s) this trial relates to.

acne Acne Vulgaris

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Acne

Contacts and locations

Locations

  • Massachusetts General Hospital

    Boston, Massachusetts, 02114, United States

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