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 study is to find out the safety and effectiveness of 1064 Q-Switch Laser Therapy compared to Glycolic Acid Chemical Peels for the treatment of melasma.
Participants in this study will be patients at the dermatology clinic who are clinically diagnosed with at least a 2X2 cm patch of melasma on each side of their face (forehead or cheek). Starting at 2 weeks before treatment (week 2), both sides will be pretreated and primed with 4% hydroquinone with, if necessary, 2.5% hydrocortisone cream BID. On the treatment day (2-weeks) and 6-weeks one half of the subject's face will receive glycolic acid peels and the other half of the face will receive 1064nm Q-switch laser. This study is a pilot study designed to determine feasibility of these procedures.
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 1064nm Q-switch Laser | Active Comparator | The 1064 Q-Switch Laser is a medical device that uses a focused laser to remove dark pigment (color) from the skin. |
|
| Glycolic Acid Peels | Active Comparator | A Glycolic Acid Chemical Peel is a mild skin treatment used to correct uneven texture and color by removing dead cells from the skin's outermost layer. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 1064nm Q-switch Laser | Device |
| ||
| Glycolic Acid Peels |
| Measure | Description | Time Frame |
|---|---|---|
| Visual Analog Scale (VAS) of Improvement Rated by a Blinded Dermatologist From at Week 10 | The primary outcome was a blinded rating of improvement of the treatment area (1064nm Q-switch Laser Versus Glycolic Acid Peels) using a Visual Analog Scale (VAS). A dermatologist blindly evaluated the treated areas of each side from live subjects at baseline on the final follow up visit (week 10). The VAS of improvement was rated on a scale of 0 to10, with 0 being no improvement and 10 being the most improvement seen by the treatment. | Week 10 |
Not provided
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Murad Alam, MD | Northwestern University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Northwestern University Department of Dermatology | Chicago | Illinois | 60611 | United States |
Not provided
Not provided
Not provided
| ID | Title | Description |
|---|---|---|
| FG000 | Q-switch Laser Left, Glycolic Acid Peels Comparator Right | The unit of randomization was the subject who was randomized 1:1 to receive glycolic acid peel on one side of the face, while the contralateral side of the face received the 1064nm Q-switch laser. Subjects in this arm were randomized to receive the interventions: 1064nm Q-switch laser on the left side of their face, and the glycolic acids peels on the right side of their face. |
| FG001 | Glycolic Acid Peels Comparator Left, Q-Switch Laser Right | The unit of randomization was the subject who was randomized 1:1 to receive glycolic acid peel on one side of the face, while the contralateral side of the face received the 1064nm Q-switch laser. Subjects in this arm were randomized to receive the interventions: 1064nm Q-switch laser on the right side of their face, and the glycolic acids peels on the left side of their face. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
Not provided
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | Q-switch Laser Left, Glycolic Acid Peels Comparator Right | The unit of randomization was the subject who was randomized 1:1 to receive glycolic acid peel on one side of the face, while the contralateral side of the face received the 1064nm Q-switch laser. Subjects in this arm were randomized to receive the interventions: 1064nm Q-switch laser on the left side of their face, and the glycolic acids peels on the right side of their face. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| 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 | Visual Analog Scale (VAS) of Improvement Rated by a Blinded Dermatologist From at Week 10 | The primary outcome was a blinded rating of improvement of the treatment area (1064nm Q-switch Laser Versus Glycolic Acid Peels) using a Visual Analog Scale (VAS). A dermatologist blindly evaluated the treated areas of each side from live subjects at baseline on the final follow up visit (week 10). The VAS of improvement was rated on a scale of 0 to10, with 0 being no improvement and 10 being the most improvement seen by the treatment. | Posted | Mean | Standard Deviation | units on a scale | Week 10 |
|
6 months
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 | 1064nm Q-switch Laser | The 1064 Q-Switch Laser is a medical device that uses a focused laser to remove dark pigment (color) from the skin. 1064nm Q-switch Laser |
Not provided
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Hyperpigmentation | Skin and subcutaneous tissue disorders | Non-systematic Assessment |
Not provided
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Murad Alam | Northwestern University | 312-695-4761 | m-alam@northwestern.edu |
Not provided
| ID | Term |
|---|---|
| D008548 | Melanosis |
| ID | Term |
|---|---|
| D017495 | Hyperpigmentation |
| D010859 | Pigmentation Disorders |
| D012871 | Skin Diseases |
| D017437 | Skin and Connective Tissue Diseases |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
|
| BG001 | Glycolic Acid Peels Comparator Left, Q-Switch Laser Right | The unit of randomization was the subject who was randomized 1:1 to receive glycolic acid peel on one side of the face, while the contralateral side of the face received the 1064nm Q-switch laser. Subjects in this arm were randomized to receive the interventions: 1064nm Q-switch laser on the right side of their face, and the glycolic acids peels on the left side of their face. |
| BG002 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants |
|
A Glycolic Acid Chemical Peel is a mild skin treatment used to correct uneven texture and color by removing dead cells from the skin's outermost layer. Glycolic Acid Peels |
|
|
| 0 |
| 20 |
| 0 |
| 20 |
| 0 |
| 20 |
| EG001 | Glycolic Acid Peels | A Glycolic Acid Chemical Peel is a mild skin treatment used to correct uneven texture and color by removing dead cells from the skin's outermost layer. Glycolic Acid Peels | 0 | 20 | 0 | 20 | 3 | 20 |
| Blistering/Scabbing | Skin and subcutaneous tissue disorders | Non-systematic Assessment |
|
Not provided
Not provided
Not provided