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| Tracking Information | |||||
|---|---|---|---|---|---|
| First Received Date ICMJE | June 7, 2005 | ||||
| Last Updated Date | July 14, 2008 | ||||
| Start Date ICMJE | August 2005 | ||||
| Estimated Primary Completion Date | March 2010 (final data collection date for primary outcome measure) | ||||
| Current Primary Outcome Measures ICMJE |
Subtypes of acne lesions including papules, pustules, cysts, open comedones, and closed comedones [ Time Frame: These outcomes will be measured at follow-up evaluation visits during the treatment series, and up to every four weeks following the final treatment for a total of up to12 weeks. ] [ Designated as safety issue: No ] | ||||
| Original Primary Outcome Measures ICMJE |
Subtypes of acne lesions including papules, pustules, cysts, open comedones, and closed comedones | ||||
| Change History | Complete list of historical versions of study NCT00113425 on ClinicalTrials.gov Archive Site | ||||
| Current Secondary Outcome Measures ICMJE |
cutaneous sebum production (optional) [ Time Frame: Sebum production will be measured at baseline, at follow-up evaluation visits during the treatment series, and up to every four weeks following the final laser treatment for a total of up to 12 weeks. ] [ Designated as safety issue: No ] | ||||
| Original Secondary Outcome Measures ICMJE |
cutaneous sebum production | ||||
| Descriptive Information | |||||
| Brief Title ICMJE | Non-Cutting Laser Therapy in the Treatment of Acne | ||||
| Official Title ICMJE | Photodynamic Therapy in the Treatment of Acne Vulgaris | ||||
| Brief Summary | The purpose of this research project is to study the effect of non-ablative (non-cutting) laser therapy, a technique that uses laser energy to try to improve the appearance of the skin. This type of laser treatment creates changes in a layer of the skin called the dermis without causing an open wound in the skin. The use of non-ablative laser therapy, together with application of a photo-sensitizer (substance that makes the skin more sensitive to light), may improve the appearance of acne. The idea behind the photo-sensitizer is that it is supposed to make the laser more effective than using just the laser alone. It is not yet clear how much improvement can be seen with these treatments or exactly how the skin's response causes these improvements. In this study, we are interested in learning how well such a laser works to improve the symptoms of acne, as well as how much the photo-sensitizer actually enhances the efficacy of the laser. |
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| Detailed Description | Acne vulgaris remains among the most common cutaneous disorders, impacting the vast majority of people at some point during their lives. It is associated with significant psychosocial morbidity, and there remains the need for efficacious and low risk therapeutic options. Recently, the FDA has approved various lasers for the treatment of acne. However, few randomized, controlled clinical trials have been performed. In addition, the use of topical photosensitizers preceding laser therapy for acne has also been examined in a preliminary way with some initial evidence of efficacy. However, these small trials have primarily focused on back acne and have included modest numbers of subjects. Photodynamic therapy for facial acne is being performed by physicians across the country but little objective data regarding this practice is available. We propose to evaluate the efficacy and confirm the safety of pulsed dye laser therapy (V-Beam laser, Candela Corp., Wayland, MA, 595 nm wavelength) used in conjunction with a topical photosensitizer in the treatment of acne vulgaris. This is a split-face comparison study in which one half of the face will be treated with photo-sensitizer and laser, and the contralateral side will be left untreated. Because one proposed mechanism of action for such treatments includes altered sebaceous gland activity, we also seek to examine the effects of this treatment on cutaneous sebum production. |
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| Study Phase | Phase II | ||||
| Study Type ICMJE | Interventional | ||||
| Study Design ICMJE | Treatment, Randomized, Single Blind (Outcomes Assessor), Active Control, Single Group Assignment, Safety/Efficacy Study | ||||
| Condition ICMJE | Acne Vulgaris | ||||
| Intervention ICMJE | Device: V-Beam laser, Candela Corp., 595 nm wavelength | ||||
| Study Arms / Comparison Groups | |||||
| Publications * | |||||
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* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline. |
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| Recruitment Information | |||||
| Recruitment Status ICMJE | Active, not recruiting | ||||
| Estimated Enrollment ICMJE | 75 | ||||
| Estimated Completion Date | March 2010 | ||||
| Estimated Primary Completion Date | March 2010 (final data collection date for primary outcome measure) | ||||
| Eligibility Criteria ICMJE | Inclusion Criteria:
Exclusion Criteria:
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| Gender | Both | ||||
| Ages | 15 Years and older | ||||
| Accepts Healthy Volunteers | No | ||||
| Contacts ICMJE | Contact information is only displayed when the study is recruiting subjects | ||||
| Location Countries ICMJE | United States | ||||
| Administrative Information | |||||
| NCT ID ICMJE | NCT00113425 | ||||
| Responsible Party | Jeffrey Orringer, MD, Clinical Assistant Professor, University of Michigan Department of Dermatology | ||||
| Study ID Numbers ICMJE | Derm 548 | ||||
| Study Sponsor ICMJE | University of Michigan | ||||
| Collaborators ICMJE | |||||
| Investigators ICMJE |
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| Information Provided By | University of Michigan | ||||
| Verification Date | July 2008 | ||||
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ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |
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