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This study will conduct a split-face and -body randomized control trial to compare lidocaine 2.5%/prilocaine 2.5% topical anesthetic (LPTA), lidocaine 7%/tetracaine 7% topical anesthetic (LTTA), and placebo vechicle (PV) on patients' pain perceptions with Q-switched 532nm laser for the treatment of lentigines and/or photorejuvenation.Subjects will fill out a pain score on a visual analog scale (VAS) with 0 being no pain and 10 being most pain after each treatment area is completed.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| lidocaine 2.5%/prilocaine 2.5% topical anesthetic | Active Comparator | Subjects will be screened, assessed, and randomized to be treated with a single pass of the Q-switched 532nm laser after application of LPTA, LTTA, or PV under occlusion to the assigned randomized site. |
|
| lidocaine 7%/tetracaine 7% topical anesthetic | Active Comparator | Subjects will be screened, assessed, and randomized to be treated with a single pass of the Q-switched 532nm laser after application of LPTA, LTTA, or PV under occlusion to the assigned randomized site. |
|
| placebo vehicle | Placebo Comparator | Subjects will be screened, assessed, and randomized to be treated with a single pass of the Q-switched 532nm laser after application of LPTA, LTTA, or PV under occlusion to the assigned randomized site. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| lidocaine 2.5%/prilocaine 2.5% topical anesthetic | Drug |
| ||
| lidocaine 7%/tetracaine 7% topical anesthetic |
| Measure | Description | Time Frame |
|---|---|---|
| visual analog score (VAS) pain rating | Subjects will fill out a visual analog score (VAS) pain rating after treatment with 0 being no pain and 10 being worst pain | Day of treatment |
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Inclusion Criteria:
Exclusion Criteria:
Younger than 25 or older than 65 years of age.
Pregnant or lactating.
Is a male.
Has received the following treatments on the face:
Has an active infection on the face or upper inner arms (excluding mild acne).
Is allergic to lidocaine, tetracaine, or prilocaine.
Has kidney disease and/or liver disease.
Has G-6-PD and/or pseudocholinesterase deficiency.
Is taking a class I anti-arrhythmic medication.
Is tanned.
Has a history of hyperpigmentation with laser treatment.
Has a mental illness.
Has a history of a chronic pain condition such as fibromyalgia or vulvodynia.
Unable to understand the protocol or to give informed consent.
Multiply recurrent episodes of cold sores.
Any significant skin disease beyond mild acne.
Any other condition that would, in the professional opinion of the investigator, potentially affect response or participation in the clinical clinical study, or would pose as an unacceptable risk to the subject.
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| Name | Affiliation | Role |
|---|---|---|
| Murad Alam, MD | Northwestern University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Northwestern University Feinberg School of Medicine, Department of Dermatology | Chicago | Illinois | 60611 | United States |
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| Drug |
|
| placebo vehicle | Drug |
|
| Q-switched 532nm Laser | Device |
|
| ID | Term |
|---|---|
| D007911 | Lentigo |
| ID | Term |
|---|---|
| D008548 | Melanosis |
| D017495 | Hyperpigmentation |
| D010859 | Pigmentation Disorders |
| D012871 | Skin Diseases |
| D017437 | Skin and Connective Tissue Diseases |
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| ID | Term |
|---|---|
| D008012 | Lidocaine |
| D011318 | Prilocaine |
| D000779 | Anesthetics, Local |
| D013748 | Tetracaine |
| D007834 | Lasers |
| ID | Term |
|---|---|
| D000083 | Acetanilides |
| D000813 | Anilides |
| D000577 | Amides |
| D009930 | Organic Chemicals |
| D000814 | Aniline Compounds |
| D000588 | Amines |
| D000777 | Anesthetics |
| D002492 | Central Nervous System Depressants |
| D045505 | Physiological Effects of Drugs |
| D020228 | Pharmacologic Actions |
| D020164 | Chemical Actions and Uses |
| D018689 | Sensory System Agents |
| D018373 | Peripheral Nervous System Agents |
| D002491 | Central Nervous System Agents |
| D045506 | Therapeutic Uses |
| D062366 | para-Aminobenzoates |
| D062365 | Aminobenzoates |
| D001565 | Benzoates |
| D000146 | Acids, Carbocyclic |
| D002264 | Carboxylic Acids |
| D001555 | Benzene Derivatives |
| D006841 | Hydrocarbons, Aromatic |
| D006844 | Hydrocarbons, Cyclic |
| D006838 | Hydrocarbons |
| D055096 | Optical Devices |
| D004864 | Equipment and Supplies |
| D055618 | Radiation Equipment and Supplies |
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