What It Is
Pliaglis Cream (Galderma Laboratories, L.P.) is the first self-occlusive topical 7% lidocaine/7% tetracaine anesthetic cream approved by the FDA to provide local topical anesthesia in adults undergoing superficial dermatological procedures.1 This is the highest concentration of active anesthetic ingredients available in an FDA-approved topical cream.
What makes Pliaglis especially unique is how it is applied. It is administered as a cream, but when exposed to air, forms a pliable membrane on the skin, which, after a period of 20 to 30 minutes, is peeled, rendering the skin effectively anesthesized for most superficial dermatologic procedures.1
Indications for Use
Pliaglis is indicated for use on intact skin in adults to provide topical local analgesia for superficial dermatological procedures such as dermal filler injections, pulsed dye laser (PDL) therapy, facial laser resurfacing and laser-assisted tattoo removal.1
Safety and Efficacy Studies
Numerous studies demonstrated the safety and efficacy of Pliaglis for a wide range of superficial dermatologic procedures.
Pliaglis vs. EMLA
One 20-subject study compared Pliaglis to eutectic mixture of local anesthetics (EMLA), which is the most widely used topical anesthetic. Pliaglis showed superior anesthesia for cutaneous laser resurfacing on the face.2 Both Pliaglis and EMLA were applied to bilateral (split-face) 4-cm x 4-cm areas of the cheek for 30 minutes prior to single-pass CO2 resurfacing.2 The mean patient ratings using a visual analogue scale were 2.66 for Pliaglis vs. 5.25 for EMLA.3 Of the patients studied, 95% (19/20) reported adequate pain relief with the use of Pliaglis.3
Placebo-Controlled Clinical Trials
As Tina Alster, M.D., F.A.A.D., reports in the September 2007 issue of Dermatologic Surgery, the efficacy and safety of Pliaglis has been evaluated in numerous placebo-controlled clinical trials involving a total of 382 adult subjects undergoing various superficial dermatologic procedures.4 In that same paper, Alster notes that patients undergoing PDL for facial vascular lesions, active treatment and placebo creams were applied 20 minutes before the procedures.4 Alster also discusses other procedures using Pliaglis such as cryotherapy, dermal fillers, laser-assisted hair removal and nonablative facial resurfacing in subjects who were treated 30 minutes pre-procedure; PDL for facial telangiectasia/port wine stain, laser leg vein ablation and laser-assisted tattoo removal patients were treated 60 minutes pre-procedure.4
Within all study cohorts, it was reported that significantly more patients indicated that they had received adequate anesthesia and that they would use Pliaglis again, versus those using placebo.4
Adverse Events
Alster also reported on adverse events associated with use of Pliaglis in the various studies undertaken with the product. Local reactions among Pliaglis-treated patients generally consisted of erythema, pruritus, blanching and edema.5 They were considered to be generally mild and transient, did not interfere with clinical outcomes, and resolved soon after treatment.6
Clinical Benefits
The anesthetic combination in Pliaglis contains the highest concentration of active topical anesthetic ingredients of any topical cream approved by the FDA. Previously published research suggests that lidocaine provides rapid onset of action, and tetracaine may provide a lasting effect that may help to control post-procedural discomfort.7
The self-occluding formulation eliminates the need for occlusive wraps.8 Unlike other topical anesthetic creams or gels, Pliaglis provides for a less messy and more elegant transition from anesthesia to procedure.9
Since Pliaglis conforms to contours of the skin, it is well suited for application to the face.9
Application and Product Handling
• Pliaglis should be applied with a flat-surfaced tool such as metal spatula or tongue depressor.1
• It should be spread evenly across the selected treatment area to approximately 1 mm thickness or about the thickness of a dime.1
• The cream will begin to transform into a pliable membrane.
• For superficial dermatologic procedures, such as dermal filler injections, Pliaglis is applied for 20 to 30 minutes.1
• For superficial cosmetic procedures that involve a laser or similar device, which may be considered more painful, Pliaglis must remain on the skin for up to 60 minutes.1
• The pliable peel is easy to remove and should be discarded out of reach of children.1,9
• Pliaglis must be stored at a temperature from 2 to 8 degrees Celsius (36 to 46 degrees Fahrenheit).1
• Pliaglis should never be frozen.1
What It Is
Pliaglis Cream (Galderma Laboratories, L.P.) is the first self-occlusive topical 7% lidocaine/7% tetracaine anesthetic cream approved by the FDA to provide local topical anesthesia in adults undergoing superficial dermatological procedures.1 This is the highest concentration of active anesthetic ingredients available in an FDA-approved topical cream.
What makes Pliaglis especially unique is how it is applied. It is administered as a cream, but when exposed to air, forms a pliable membrane on the skin, which, after a period of 20 to 30 minutes, is peeled, rendering the skin effectively anesthesized for most superficial dermatologic procedures.1
Indications for Use
Pliaglis is indicated for use on intact skin in adults to provide topical local analgesia for superficial dermatological procedures such as dermal filler injections, pulsed dye laser (PDL) therapy, facial laser resurfacing and laser-assisted tattoo removal.1
Safety and Efficacy Studies
Numerous studies demonstrated the safety and efficacy of Pliaglis for a wide range of superficial dermatologic procedures.
Pliaglis vs. EMLA
One 20-subject study compared Pliaglis to eutectic mixture of local anesthetics (EMLA), which is the most widely used topical anesthetic. Pliaglis showed superior anesthesia for cutaneous laser resurfacing on the face.2 Both Pliaglis and EMLA were applied to bilateral (split-face) 4-cm x 4-cm areas of the cheek for 30 minutes prior to single-pass CO2 resurfacing.2 The mean patient ratings using a visual analogue scale were 2.66 for Pliaglis vs. 5.25 for EMLA.3 Of the patients studied, 95% (19/20) reported adequate pain relief with the use of Pliaglis.3
Placebo-Controlled Clinical Trials
As Tina Alster, M.D., F.A.A.D., reports in the September 2007 issue of Dermatologic Surgery, the efficacy and safety of Pliaglis has been evaluated in numerous placebo-controlled clinical trials involving a total of 382 adult subjects undergoing various superficial dermatologic procedures.4 In that same paper, Alster notes that patients undergoing PDL for facial vascular lesions, active treatment and placebo creams were applied 20 minutes before the procedures.4 Alster also discusses other procedures using Pliaglis such as cryotherapy, dermal fillers, laser-assisted hair removal and nonablative facial resurfacing in subjects who were treated 30 minutes pre-procedure; PDL for facial telangiectasia/port wine stain, laser leg vein ablation and laser-assisted tattoo removal patients were treated 60 minutes pre-procedure.4
Within all study cohorts, it was reported that significantly more patients indicated that they had received adequate anesthesia and that they would use Pliaglis again, versus those using placebo.4
Adverse Events
Alster also reported on adverse events associated with use of Pliaglis in the various studies undertaken with the product. Local reactions among Pliaglis-treated patients generally consisted of erythema, pruritus, blanching and edema.5 They were considered to be generally mild and transient, did not interfere with clinical outcomes, and resolved soon after treatment.6
Clinical Benefits
The anesthetic combination in Pliaglis contains the highest concentration of active topical anesthetic ingredients of any topical cream approved by the FDA. Previously published research suggests that lidocaine provides rapid onset of action, and tetracaine may provide a lasting effect that may help to control post-procedural discomfort.7
The self-occluding formulation eliminates the need for occlusive wraps.8 Unlike other topical anesthetic creams or gels, Pliaglis provides for a less messy and more elegant transition from anesthesia to procedure.9
Since Pliaglis conforms to contours of the skin, it is well suited for application to the face.9
Application and Product Handling
• Pliaglis should be applied with a flat-surfaced tool such as metal spatula or tongue depressor.1
• It should be spread evenly across the selected treatment area to approximately 1 mm thickness or about the thickness of a dime.1
• The cream will begin to transform into a pliable membrane.
• For superficial dermatologic procedures, such as dermal filler injections, Pliaglis is applied for 20 to 30 minutes.1
• For superficial cosmetic procedures that involve a laser or similar device, which may be considered more painful, Pliaglis must remain on the skin for up to 60 minutes.1
• The pliable peel is easy to remove and should be discarded out of reach of children.1,9
• Pliaglis must be stored at a temperature from 2 to 8 degrees Celsius (36 to 46 degrees Fahrenheit).1
• Pliaglis should never be frozen.1
What It Is
Pliaglis Cream (Galderma Laboratories, L.P.) is the first self-occlusive topical 7% lidocaine/7% tetracaine anesthetic cream approved by the FDA to provide local topical anesthesia in adults undergoing superficial dermatological procedures.1 This is the highest concentration of active anesthetic ingredients available in an FDA-approved topical cream.
What makes Pliaglis especially unique is how it is applied. It is administered as a cream, but when exposed to air, forms a pliable membrane on the skin, which, after a period of 20 to 30 minutes, is peeled, rendering the skin effectively anesthesized for most superficial dermatologic procedures.1
Indications for Use
Pliaglis is indicated for use on intact skin in adults to provide topical local analgesia for superficial dermatological procedures such as dermal filler injections, pulsed dye laser (PDL) therapy, facial laser resurfacing and laser-assisted tattoo removal.1
Safety and Efficacy Studies
Numerous studies demonstrated the safety and efficacy of Pliaglis for a wide range of superficial dermatologic procedures.
Pliaglis vs. EMLA
One 20-subject study compared Pliaglis to eutectic mixture of local anesthetics (EMLA), which is the most widely used topical anesthetic. Pliaglis showed superior anesthesia for cutaneous laser resurfacing on the face.2 Both Pliaglis and EMLA were applied to bilateral (split-face) 4-cm x 4-cm areas of the cheek for 30 minutes prior to single-pass CO2 resurfacing.2 The mean patient ratings using a visual analogue scale were 2.66 for Pliaglis vs. 5.25 for EMLA.3 Of the patients studied, 95% (19/20) reported adequate pain relief with the use of Pliaglis.3
Placebo-Controlled Clinical Trials
As Tina Alster, M.D., F.A.A.D., reports in the September 2007 issue of Dermatologic Surgery, the efficacy and safety of Pliaglis has been evaluated in numerous placebo-controlled clinical trials involving a total of 382 adult subjects undergoing various superficial dermatologic procedures.4 In that same paper, Alster notes that patients undergoing PDL for facial vascular lesions, active treatment and placebo creams were applied 20 minutes before the procedures.4 Alster also discusses other procedures using Pliaglis such as cryotherapy, dermal fillers, laser-assisted hair removal and nonablative facial resurfacing in subjects who were treated 30 minutes pre-procedure; PDL for facial telangiectasia/port wine stain, laser leg vein ablation and laser-assisted tattoo removal patients were treated 60 minutes pre-procedure.4
Within all study cohorts, it was reported that significantly more patients indicated that they had received adequate anesthesia and that they would use Pliaglis again, versus those using placebo.4
Adverse Events
Alster also reported on adverse events associated with use of Pliaglis in the various studies undertaken with the product. Local reactions among Pliaglis-treated patients generally consisted of erythema, pruritus, blanching and edema.5 They were considered to be generally mild and transient, did not interfere with clinical outcomes, and resolved soon after treatment.6
Clinical Benefits
The anesthetic combination in Pliaglis contains the highest concentration of active topical anesthetic ingredients of any topical cream approved by the FDA. Previously published research suggests that lidocaine provides rapid onset of action, and tetracaine may provide a lasting effect that may help to control post-procedural discomfort.7
The self-occluding formulation eliminates the need for occlusive wraps.8 Unlike other topical anesthetic creams or gels, Pliaglis provides for a less messy and more elegant transition from anesthesia to procedure.9
Since Pliaglis conforms to contours of the skin, it is well suited for application to the face.9
Application and Product Handling
• Pliaglis should be applied with a flat-surfaced tool such as metal spatula or tongue depressor.1
• It should be spread evenly across the selected treatment area to approximately 1 mm thickness or about the thickness of a dime.1
• The cream will begin to transform into a pliable membrane.
• For superficial dermatologic procedures, such as dermal filler injections, Pliaglis is applied for 20 to 30 minutes.1
• For superficial cosmetic procedures that involve a laser or similar device, which may be considered more painful, Pliaglis must remain on the skin for up to 60 minutes.1
• The pliable peel is easy to remove and should be discarded out of reach of children.1,9
• Pliaglis must be stored at a temperature from 2 to 8 degrees Celsius (36 to 46 degrees Fahrenheit).1
• Pliaglis should never be frozen.1
