Loading clinical trials...

A Pilot Clinical Trial Investigating the Effect of Cutaneous Cooling on Sebum Production | Clinical Trials | Clareo Health

COMPLETEDNA

A Pilot Clinical Trial Investigating the Effect of Cutaneous Cooling on Sebum Production

Pilot Clinical Trial Investigating the Effect of Cutaneous Cooling on Sebum Production

NCT01686841•Zeltiq Aesthetics

View on ClinicalTrials.gov

Summary

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.

Eligibility

Age

18 - 25 years

Sex

MALE

Healthy Volunteers

Yes

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.

Locations (1)

Massachusetts General Hospital

Boston, Massachusetts, United States

Key Dates

Start Date

August 16, 2012

Primary Completion Date

April 29, 2013

Completion Date

December 31, 2013

Last Updated

September 18, 2025

Enrollment

ACTUAL participants

Conditions

Acne

Interventions

The Zeltiq System

DEVICE

Evaluation of Juläine (TM) for the Treatment of Atrophic Facial Acne Scars

NCT07058883

Acne Scars

View study

RECRUITINGNA

Reduction of Bacterial Seeding in Total Shoulder Arthroplasty

NCT07406893

Joint ArthroplastyShoulder+2 more

View study

RECRUITINGNA

Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: September 18, 2025Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

View ClinicalTrials.gov Terms and Conditions

A Pilot Clinical Trial Investigating the Effect of Cutaneous Cooling on Sebum Production

Inclusion Criteria

Exclusion Criteria

Evaluation of Juläine (TM) for the Treatment of Atrophic Facial Acne Scars

Reduction of Bacterial Seeding in Total Shoulder Arthroplasty

The Suitability of Tience® for Treating Acne Scars

Clindamycin Phosphate, Adapalene, and Benzoyl Peroxide Triple Combination Gel in Canadian Patients With Acne Vulgaris

Efficacy of Combined Fractional Er:Glass and Thulium Lasers Versus Microneedling for Atrophic Acne Scars

Study to Investigate the Efficacy, Safety, and Tolerability of Topical HT-001 for the Treatment of Skin Toxicities Associated With Epidermal Growth Factor Receptor Inhibitors