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

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.