Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
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.
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.
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Laser Therapy | Experimental | V-Beam laser, Candela Corp., 595 nm wavelength |
|
| Control | No Intervention | Untreated |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| V-Beam laser, Candela Corp., 595 nm wavelength | Device | Subjects will receive a series of up to 6 laser therapy sessions with a treatment interval of from approximately 1 to 4 weeks. In all cases, laser treatment parameters will be within the guidelines normally used clinically with the V-Beam laser, and thus fluences used will not exceed 15 J/cm2. |
| Measure | Description | Time Frame |
|---|---|---|
| Change From Baseline in Papule Acne Lesions at Week 10 | Baseline and Week 10 | |
| Change From Baseline in Pustule Acne Lesions at Week 10 | Baseline and Week 10 | |
| Change From Baseline in Cysts at Week 10 | Baseline and Week 10 | |
| Change From Baseline in Closed Comedones at Week 10 | Baseline and Week 10 | |
| Change From Baseline in Open Comedones at Week 10 | Baseline and Week 10 | |
| Change From Baseline in Erythematous Macules at Week 10 | Baseline and Week 10 | |
| Change From Baseline in Acne Severity at Week 10 | The Leeds scale is a 12-point ordinal photonumeric global acne severity scale where a rating of 1 denotes the mildest acne and a rating of 12 represents the most severe. | Baseline and Week 10 |
| Measure | Description | Time Frame |
|---|---|---|
| Change From Baseline in Papule Acne Lesions at Week 16 | Baseline and Week 16 | |
| Change From Baseline in Pustule Acne Lesions at Week 16 | Baseline and Week 16 | |
| Change From Baseline in Cysts at Week 16 |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| John J Voorhees, MD | University of Michigan | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Michigan Department of Dermatology | Ann Arbor | Michigan | 48109 | United States |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| ID | Title | Description |
|---|---|---|
| FG000 | All Study Participants | Patients were randomized to receive topical photosensitizer applications followed by pulsed dye laser therapy to one side of the face while the contralateral side of the face remained untreated, thus serving as an internal control. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
Not provided
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | Treated Group Pulsed Dye Laser Therapy and Untreated Group | Patients were randomized to receive topical photosensitizer applications followed by pulsed dye laser therapy to one side of the face and the contralateral side of the face remained untreated, thus serving as an internal control. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Change From Baseline in Papule Acne Lesions at Week 10 | Posted | Mean | 95% Confidence Interval | papule acne lesions | Baseline and Week 10 |
|
|
Not provided
Not provided
Not provided
| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Treated Group Pulsed Dye Laser Therapy | Patients were randomized to receive topical photosensitizer applications followed by pulsed dye laser therapy to one side of the face. |
Not provided
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Mild Peeling | Skin and subcutaneous tissue disorders | Non-systematic Assessment |
Not provided
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Jeffrey Orringer | University of Michigan Dept of Dermatology | 734-936-4075 | jorringe@umich.edu |
Not provided
| ID | Term |
|---|---|
| D000152 | Acne Vulgaris |
| ID | Term |
|---|---|
| D017486 | Acneiform Eruptions |
| D012871 | Skin Diseases |
| D017437 | Skin and Connective Tissue Diseases |
| D012625 | Sebaceous Gland Diseases |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
|
| Baseline and Week 16 |
| Change From Baseline in Closed Comedones at Week 16 | Baseline and Week 16 |
| Change From Baseline in Open Comedones at Week 16 | Baseline and Week 16 |
| Change From Baseline in Erythematous Macules at Week 16 | Baseline and Week 16 |
| Change From Baseline in Acne Severity at Week 16 | The Leeds scale is a 12-point ordinal photonumeric global acne severity scale where a rating of 1 denotes the mildest acne and a rating of 12 represents the most severe. | Baseline and Week 16 |
| Participants |
|
| Age, Continuous | Mean | Standard Deviation | years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race/Ethnicity, Customized | Number | participants |
|
| Region of Enrollment | Number | participants |
|
|
|
| Primary | Change From Baseline in Pustule Acne Lesions at Week 10 | Posted | Mean | 95% Confidence Interval | pustule acne lesions | Baseline and Week 10 |
|
|
|
|
| Primary | Change From Baseline in Cysts at Week 10 | Posted | Mean | 95% Confidence Interval | cysts | Baseline and Week 10 |
|
|
|
|
| Primary | Change From Baseline in Closed Comedones at Week 10 | Posted | Mean | 95% Confidence Interval | closed comedones | Baseline and Week 10 |
|
|
|
|
| Primary | Change From Baseline in Open Comedones at Week 10 | Posted | Mean | 95% Confidence Interval | open comedones | Baseline and Week 10 |
|
|
|
|
| Primary | Change From Baseline in Erythematous Macules at Week 10 | Posted | Mean | 95% Confidence Interval | erythematous macules | Baseline and Week 10 |
|
|
|
|
| Primary | Change From Baseline in Acne Severity at Week 10 | The Leeds scale is a 12-point ordinal photonumeric global acne severity scale where a rating of 1 denotes the mildest acne and a rating of 12 represents the most severe. | Posted | Mean | 95% Confidence Interval | units on a scale | Baseline and Week 10 |
|
|
|
|
| Secondary | Change From Baseline in Papule Acne Lesions at Week 16 | Posted | Mean | 95% Confidence Interval | papule acne lesions | Baseline and Week 16 |
|
|
|
|
| Secondary | Change From Baseline in Pustule Acne Lesions at Week 16 | Posted | Mean | 95% Confidence Interval | pustule acne lesions | Baseline and Week 16 |
|
|
|
|
| Secondary | Change From Baseline in Cysts at Week 16 | Posted | Mean | 95% Confidence Interval | cysts | Baseline and Week 16 |
|
|
|
|
| Secondary | Change From Baseline in Closed Comedones at Week 16 | Posted | Mean | 95% Confidence Interval | closed comedones | Baseline and Week 16 |
|
|
|
|
| Secondary | Change From Baseline in Open Comedones at Week 16 | Posted | Mean | 95% Confidence Interval | open comedones | Baseline and Week 16 |
|
|
|
|
| Secondary | Change From Baseline in Erythematous Macules at Week 16 | Posted | Mean | 95% Confidence Interval | erythematous macules | Baseline and Week 16 |
|
|
|
|
| Secondary | Change From Baseline in Acne Severity at Week 16 | The Leeds scale is a 12-point ordinal photonumeric global acne severity scale where a rating of 1 denotes the mildest acne and a rating of 12 represents the most severe. | Posted | Mean | 95% Confidence Interval | units on a scale | Baseline and Week 16 |
|
|
|
|
| 0 |
| 44 |
| 5 |
| 44 |
| EG001 | Untreated Group Control | The contralateral side of the face remained untreated, thus serving as an internal control. | 0 | 44 | 0 | 44 |
| Transient Postinflammatory Hyperpigmentation | Skin and subcutaneous tissue disorders | Non-systematic Assessment |
|
| Blister | Skin and subcutaneous tissue disorders | Non-systematic Assessment |
|
Not provided
Not provided
Not provided