Feasibility Study: Ulthera® System for the Treatment of Moderate to Severe Facial Acne

Launched by ULTHERA, INC · May 2, 2012

Keywords

ClinConnect Summary

Study subjects will be assigned to one of two treatment groups. Both treatment groups will receive treatment in the center of the forehead/temples, medial cheeks, and chin regions using the 1.5mm and 1.0mm transducers.

* For Group A, both the 1.5mm and 1.0mm transducers will be used at 0.25J energy setting and 0.20J energy setting, respectively.
* For Group B, both the 1.5mm and 1.0mm transducers will be used at 0.18J energy setting and 0.15J energy setting, respectively.

Subjects will receive 3 Ultherapy treatments administered 2 weeks apart. Subjects will be required to return for follo...

Gender

ALL

Eligibility criteria

• Inclusion Criteria:
• • Male or female, aged 18 years and older.
• • Subject in good health.
• • Presence of clinically-evident facial acne of moderate to severe severity with at least 20 inflammatory lesions and 20-100 noninflammatory lesions.
• Exclusion Criteria:
• • Presence of \>2 nodular lesions in the areas to be treated.
• • Presence of any cysts in the areas to be treated.
• • Presence of an active systemic or local skin disease that may affect wound healing.
• • Use of alcohol-based topical solutions or "exfoliating" agents within 1 week prior to study participation.
• • History of frequent herpes simplex infections of the face or with clinical evidence of active herpes simplex infections.
• • History of keloid scar formation.
• • Significant scarring in areas to be treated.
• • Significant open facial wounds or lesions.
• • Presence of a metal stent or implant in the facial area to be treated.