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Completed

NCT Number: NCT01686841

A 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.

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Key information

Conditions

Acne Acne Vulgaris Acneiform Eruptions Sebaceous Gland Diseases Skin Diseases Skin and Connective Tissue Diseases

Age range

18 year–25 year

Sex eligibility

Male

Study type

Interventional

Phase

Not applicable

Primary location

Massachusetts General Hospital

Boston, Massachusetts, 02114, United States

About this study

The study evaluated the use of the Zeltiq System to reduce sebum production on the upper back.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

The ZELTIQ System

Device

Non-invasive cooling is applied to the treatment area with a defined cooling rate and duration.

Other names: Cryolipolysis

Primary outcomes

  1. 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.

  2. 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.

Secondary outcomes

  1. 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

    Device- or procedure related adverse events will be tabulated; side effects of treatment will be assessed.

  2. 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

    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.

  3. Number of Side Effect Events Post-treatment by Severity.

    Time frame: Post-treatment to 4-week final follow-up visit

    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.

Sponsors and collaborators

Lead sponsor

Zeltiq Aesthetics

Industry

Registry information

Official study title

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

Important dates

Study start
2012
Primary completion
2013
Study completion
2013
First posted
Sep 18, 2012
Registry last updated
Sep 18, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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