Pilot Clinical Trial Investigating the Effect of Cutaneous Cooling on Sebum Production
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- Enrollment
- 11
- Locations
- 2
- Primary Endpoint
- Percent Change in Sebum Production in Treated Sites as Compared to Baseline Using Sebutape Measurements.
Study Overview
Brief 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.
Study Design
- Study Type
- Interventional
- Allocation
- Na
- Intervention Model
- Single Group
- Primary Purpose
- Other
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to 25 Years (Adult)
- Sex
- Male
- Accepts Healthy Volunteers
- Yes
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.
Outcomes
Primary Outcomes
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.
Secondary Outcomes
- The Number of Device- or Procedure-related Adverse Events Will be Tabulated.(Time of enrollment through the final 4-week follow-up visit)
- Percent Change From Baseline of Sebum Production as Measured With Sebutape(72 hours post-treatment, 1 week post-treatment and 4 weeks post-treatment)
- Number of Side Effect Events Post-treatment by Severity.(Post-treatment to 4-week final follow-up visit)