Ignite Creation Date:
2024-05-05 @ 11:44 AM
Last Modification Date:
2024-10-26 @ 9:12 AM
Study NCT ID:
NCT00113425
Status:
COMPLETED
Last Update Posted:
2016-10-18
First Post:
2005-06-07
Brief Title:
Non-cutting Laser Therapy in the Treatment of Acne
Sponsor:
University of Michigan
Organization:
University of Michigan
Study Overview
Official Title:
Photodynamic Therapy in the Treatment of Acne Vulgaris
Status:
COMPLETED
Status Verified Date:
2016-08
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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 skins 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
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
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
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None