TattooPhase 4OPTICANCT02372786
7% Lidocaine/7% Tetracaine Cream Versus 2,5% Lidocaine / 2,5% Prilocaine Cream
A Phase 4 study testing 2,5% lidocaine / 2,5% prilocaine cream, 7% lidocaine / 7% tetracaine cream and Neodymium-doped yttrium aluminium garnet (Nd:Yag) laser in people with Tattoo and Acne Keloidalis Nuchae, run by Erasmus Medical Center at 1 site in Netherlands.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Tattoo, Acne Keloidalis Nuchae
- What is being tested?
- 2,5% lidocaine / 2,5% prilocaine cream, 7% lidocaine / 7% tetracaine cream and Neodymium-doped yttrium aluminium garnet (Nd:Yag) laser
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteNetherlands
- Study dates
- Nov 2014to Sep 2015
- Phase
- Phase 4
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- • Subject has provided written informed consent;
- Subject is ≥ 18 years of age at time of screening;
- Group A: subjects with acne keloidalis nuchae;
- Group B: subjects with an uniform, black, professionally placed tattoo
Who cannot join
- • Known sensitivity to any components of the test materials;
- Pregnant or breast-feeding women;
- Use of any other pain medication during past 24 hours prior to the laser treatment;
- Damaged skin at the designated treatment site;
- Blister formation and/or scar formation after test-treatment with standard laser settings;
- Any medical or psychiatric condition which, in the investigator's opinion, would preclude the participant from adhering to the protocol or completing the study per protocol.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Double Blind Randomized Controlled Trial Comparing the Efficacy of 7% Lidocaine / 7% Tetracaine Cream Versus 2,5% Lidocaine / 2,5% Prilocaine Cream for Local Anaesthesia During Laser Treatment of Acne Keloidalis Nuchae and Tattoo Removal
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.
Read the detailed description
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:
- assess the severity of pain experienced (VAS score) during laser treatment,
- evaluate whether the pain relief is adequate and,
- evaluate the amount of money patients would be willing to pay for the cream that provided the 'best' pain relief.
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.
- Conditions
- Tattoo, Acne Keloidalis Nuchae
- Being tested
- 2,5% lidocaine / 2,5% prilocaine cream, 7% lidocaine / 7% tetracaine cream, Neodymium-doped yttrium aluminium garnet (Nd:Yag) laser, Q-switched nd Yag laser
- Keywords
- 7% lidocaine / 7% tetracaine cream, 2,5% lidocaine / 2,5% prilocaine cream
- Medical subject headings
- Acne Keloid
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
2,5% lidocaine / 2,5% prilocaine creamDrug
Also called Emla®
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.
7% lidocaine / 7% tetracaine creamDrug
Also called Pliaglis®
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.
Neodymium-doped yttrium aluminium garnet (Nd:Yag) laserDevice
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.
Q-switched nd Yag laserDevice
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Drug: 2,5% lidocaine / 2,5% prilocaine cream; Drug: 7% lidocaine / 7% tetracaine cream; Device: Neodymium-doped yttrium aluminium garnet (Nd:Yag) laser |
| 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. Receives: Drug: 2,5% lidocaine / 2,5% prilocaine cream; Drug: 7% lidocaine / 7% tetracaine cream; Device: Q-switched nd Yag laser |
What is being measured
The primary outcome is the main question the study is designed to answer.
Self-reported pain (10 point visual analog scale).
Measured: 5 minutes
Secondary outcomes (3)
adequate pain relief (yes/no);
Measured: 10 minutes
willing to spend around 25 euro for best pain relief (yes/no).
Measured: 10 minutes
To monitor the nature and frequency of adverse events
Measured: one week
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Feb 2015 (estimated)
- Study startNov 2014
- Primary completionSep 2015
- Study completionSep 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for TattooStudies of the same condition, open and under way.
- More trials run by Erasmus Medical CenterThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 30 participants (actual)
Sponsor and investigators
- Lead sponsor
- Erasmus Medical Center
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, M.B.A. van Doorn, Erasmus Medical Center
- Investigators
- Martijn van Doorn, MD, PhD, Principal investigator, Erasmus Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02372786
- Sponsor's protocol ID
- MEC-2014-517_OPTICA
- Acronym
- OPTICA
- Status last verified
- Jan 2016
- First submitted
- 12 Feb 2015
- Last updated
- 20 Jan 2016
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 20 Jan 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Double Blind Randomized Controlled Trial Comparing the Efficacy of 7% Lidocaine / 7% Tetracaine Cream Versus 2,5% Lidocaine / 2,5% Prilocaine Cream for Local Anaesthesia During Laser Treatment of Acne Keloidalis Nuchae and Tattoo Removal
- ClinicalTrials.gov ID
- NCT02372786
- Acronym / sponsor ID
- OPTICA / MEC-2014-517_OPTICA
- Conditions
- Tattoo, Acne Keloidalis Nuchae
- Keywords
- 7% lidocaine / 7% tetracaine cream, 2,5% lidocaine / 2,5% prilocaine cream
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 30 participants (actual)
- Lead sponsor
- Erasmus Medical CenterUniversity, hospital or other
- Study start
- Nov 2014
- Primary completion
- Sep 2015 (actual)
- Study completion
- Sep 2015 (actual)
- First posted
- 26 Feb 2015 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
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:
- assess the severity of pain experienced (VAS score) during laser treatment,
- evaluate whether the pain relief is adequate and,
- evaluate the amount of money patients would be willing to pay for the cream that provided the 'best' pain relief.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Acne Keloidalis Nuchae | Other | Drug: 2,5% lidocaine / 2,5% prilocaine cream, Drug: 7% lidocaine / 7% tetracaine cream, Device: Neodymium-doped yttrium aluminium garnet (Nd:Yag) laser2,5% 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. |
| Tattoo | Other | Drug: 2,5% lidocaine / 2,5% prilocaine cream, Drug: 7% lidocaine / 7% tetracaine cream, Device: Q-switched nd Yag laser2,5% 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- • Subject has provided written informed consent;
Key exclusion criteria (6 listed)
- • Known sensitivity to any components of the test materials;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 2,5% lidocaine / 2,5% prilocaine creamAlso: Emla®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. | Drug | Acne Keloidalis Nuchae, Tattoo |
| 7% lidocaine / 7% tetracaine creamAlso: Pliaglis®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. | Drug | Acne Keloidalis Nuchae, Tattoo |
| Neodymium-doped yttrium aluminium garnet (Nd:Yag) laserAcne 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. | Device | Acne Keloidalis Nuchae |
| Q-switched nd Yag laserTattoo 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. | Device | Tattoo |
Primary outcome
Self-reported pain (10 point visual analog scale).
Time frame: 5 minutes
3 secondary outcomes
adequate pain relief (yes/no);
Time frame: 10 minutes
willing to spend around 25 euro for best pain relief (yes/no).
Time frame: 10 minutes
To monitor the nature and frequency of adverse events
Time frame: one week
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Jan 2016.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Martijn van Doorn, MD, PhD principal investigator
Erasmus Medical Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing 2,5% lidocaine / 2,5% prilocaine cream, 7% lidocaine / 7% tetracaine cream and Neodymium-doped yttrium aluminium garnet (Nd:Yag) laser in people with Tattoo and Acne Keloidalis Nuchae, run by Erasmus Medical Center at 1 site in Netherlands.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 20 Jan 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Netherlands. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Self-reported pain (10 point visual analog scale). (time frame: 5 minutes). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 Jan 2016.