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The purpose of this study is to compare the efficacy of 7% lidocaine / 7% tetracaine cream and 2,5% lidocaine / 2,5% prilocaine cream in reducing self-reported pain during a single laser procedure in the treatment of acne keloidalis nuchae and tattoo removal.
In this study we will compare the efficacy of 7% lidocaine / 7% tetracaine cream and 2,5% lidocaine / 2,5% prilocaine cream in reducing self-reported pain during a single laser procedure in the treatment of acne keloidalis nuchae and tattoo removal. Patients will be asked to fill in questionnaires to:
One week after the visit the patient will have a telephone consultation. The patients will be asked if they experienced any symptoms, which will be recorded as adverse events.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Acne Keloidalis Nuchae | Other | 2,5% lidocaine / 2,5% prilocaine cream and 7% lidocaine / 7% tetracaine cream will be applied for 60 minutes. After removal of the creams patients will recieve laser hair removal treatment using a neodymium-doped yttrium aluminium garnet (Nd:Yag) laser. |
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| Tattoo | Other | 2,5% lidocaine / 2,5% prilocaine cream and 7% lidocaine / 7% tetracaine cream will be applied for 60 minutes. After removal of the creams patients will recieve laser tattoo removal treatment using a Q-switched nd Yag laser. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 2,5% lidocaine / 2,5% prilocaine cream | Drug | The treatment area will be divided in two equal parts with white markings. Between these two areas an area of 1 cm will be marked. This area will be left untreated, to avoid possible spill-over effects of the two anaesthetic creams. A thick layer of 2,5% lidocaine / 2,5% prilocaine cream will be applied on one side to the intact skin under plastic occlusion (average of 1,5-2g per 10 cm2) 60 minutes before laser treatment. |
| Measure | Description | Time Frame |
|---|---|---|
| Self-reported pain (10 point visual analog scale). | 5 minutes |
| Measure | Description | Time Frame |
|---|---|---|
| adequate pain relief (yes/no); | 10 minutes | |
| willing to spend around 25 euro for best pain relief (yes/no). | 10 minutes | |
| To monitor the nature and frequency of adverse events |
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Inclusion Criteria:
• Subject has provided written informed consent;
Exclusion Criteria:
• Known sensitivity to any components of the test materials;
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| Name | Affiliation | Role |
|---|---|---|
| Martijn van Doorn, MD, PhD | Erasmus Medical Center | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Erasmus MC | Rotterdam | South Holland | 3015CA | Netherlands |
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|
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| 7% lidocaine / 7% tetracaine cream | Drug | The treatment area will be divided in two equal parts with white markings. Between these two areas an area of 1 cm will be marked. This area will be left untreated, to avoid possible spill-over effects of the two anaesthetic creams. A thin layer of 7% lidocaine / 7% tetracaine cream (1mm) will be applied on the other side to the intact skin (average of 1,3g Pliaglis per 10 cm2) 60 minutes before laser treatment. |
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| Neodymium-doped yttrium aluminium garnet (Nd:Yag) laser | Device | Acne keloidalis nuchae: during this study a 1064 nm Nd:yag laser with a spot size of 7-10 mm, and a fluence of 35-60J/cm2, (depending on the effective and safe clinical response), a pulse duration of 20-35 ms and 2 passes will be used. |
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| Q-switched nd Yag laser | Device | Tattoo removal: we will use a 3 mm spotsize and a fluence depending on the absorption of the laser light, which is visible as skin whitening. |
|
| one week |
| ID | Term |
|---|---|
| D000153 | Acne Keloid |
| ID | Term |
|---|---|
| D007627 | Keloid |
| D003095 | Collagen Diseases |
| D003240 | Connective Tissue Diseases |
| D017437 | Skin and Connective Tissue Diseases |
| D017486 | Acneiform Eruptions |
| D012871 | Skin Diseases |
| D005499 | Folliculitis |
| D006201 | Hair Diseases |
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| ID | Term |
|---|---|
| D000077442 | Lidocaine, Prilocaine Drug Combination |
| D008012 | Lidocaine |
| D007834 | Lasers |
| ID | Term |
|---|---|
| D000083 | Acetanilides |
| D000813 | Anilides |
| D000577 | Amides |
| D009930 | Organic Chemicals |
| D011318 | Prilocaine |
| D000814 | Aniline Compounds |
| D000588 | Amines |
| D004338 | Drug Combinations |
| D004364 | Pharmaceutical Preparations |
| D055096 | Optical Devices |
| D004864 | Equipment and Supplies |
| D055618 | Radiation Equipment and Supplies |
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