LentigoEarly Phase 1NCT02427724
The Effect of Topical Anesthetics on Patients' Pain and Operative Experience During Treatment With QSwitched Laser
A Early Phase 1 study testing lidocaine 2.5%/prilocaine 2.5% topical anesthetic, lidocaine 7%/tetracaine 7% topical anesthetic and Q-switched 532nm Laser in people with Lentigo, run by Northwestern University at 1 site in United States.
Trial summary
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… Read more about this study
- Who is it for?
- Ages 25 to 65 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Lentigo
- What is being tested?
- lidocaine 2.5%/prilocaine 2.5% topical anesthetic, lidocaine 7%/tetracaine 7% topical anesthetic and Q-switched 532nm Laser
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 48 participants
- Where
- 1 siteUnited States
- Study dates
- Apr 2015to 30 May 2024
- Phase
- Early Phase 1
- 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 25 to 65 years
- Women only
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Patients who have moderate lentigines and/or photodamage and desire laser toning.
- Females 25-65 years of age.
- In good health.
- Have Fitzpatrick phototype I-III.
- Willingness and the ability to understand and provide informed consent and communicate with the investigator/study staff.
Who cannot join
- Younger than 25 or older than 65 years of age.
- Pregnant or lactating.
- Is a male.
- Has received the following treatments on the face:
- ablative or non-ablative laser procedure in the past 3 months
- radiofrequency device treatment in the past 3 months
Show all 21Show fewer
- ultrasound device treatment in the past 3 months
- medium to deep chemical peel in the past 3 months
- 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.
Trial locations and contacts
1 site in 1 country.
United States1 site
Northwestern University Feinberg School of Medicine, Department of Dermatology
Chicago, Illinois, 60611
About this study
Official title: The Effect of Topical Anesthetic Using Lidocaine 2.5%/Prilocaine 2.5% Versus Lidocaine 7%/Tetracaine 7% Cream on Patients' Pain and Operative Experience During Treatment With QSwitched 532nm Laser
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.
- Conditions
- Lentigo
- Being tested
- lidocaine 2.5%/prilocaine 2.5% topical anesthetic, lidocaine 7%/tetracaine 7% topical anesthetic, placebo vehicle, Q-switched 532nm Laser
- Medical subject headings
- Lentigo
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
lidocaine 2.5%/prilocaine 2.5% topical anestheticDrug
lidocaine 7%/tetracaine 7% topical anestheticDrug
placebo vehicleDrug
Q-switched 532nm LaserDevice
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Drug: lidocaine 2.5%/prilocaine 2.5% topical anesthetic; Device: Q-switched 532nm Laser |
| 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. Receives: Drug: lidocaine 7%/tetracaine 7% topical anesthetic; Device: Q-switched 532nm Laser |
| 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. Receives: Drug: placebo vehicle; Device: Q-switched 532nm Laser |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: Day of treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Apr 2015 (estimated)
- Study startApr 2015
- Primary completion30 May 2024
- Study completion30 May 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for LentigoStudies of the same condition, open and under way.
- More trials run by Northwestern UniversityThe 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
- Early Phase 1
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 48 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Northwestern University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Murad Alam, Northwestern University
- Investigators
- Murad Alam, MD, Principal investigator, Northwestern University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02427724
- Sponsor's protocol ID
- STU200401
- Status last verified
- Jun 2026
- First submitted
- 13 Apr 2015
- Last updated
- 1 Jul 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 1 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Topical Anesthetic Using Lidocaine 2.5%/Prilocaine 2.5% Versus Lidocaine 7%/Tetracaine 7% Cream on Patients' Pain and Operative Experience During Treatment With QSwitched 532nm Laser
- ClinicalTrials.gov ID
- NCT02427724
- Acronym / sponsor ID
- STU200401
- Conditions
- Lentigo
- Phase
- Early Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 48 participants (estimated)
- Lead sponsor
- Northwestern UniversityUniversity, hospital or other
- Study start
- Apr 2015
- Primary completion
- 30 May 2024 (actual)
- Study completion
- 30 May 2024 (actual)
- First posted
- 28 Apr 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.
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.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| lidocaine 2.5%/prilocaine 2.5% topical anesthetic | Active comparator | Drug: lidocaine 2.5%/prilocaine 2.5% topical anesthetic, Device: Q-switched 532nm LaserSubjects 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 | Drug: lidocaine 7%/tetracaine 7% topical anesthetic, Device: Q-switched 532nm LaserSubjects 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 | Drug: placebo vehicle, Device: Q-switched 532nm LaserSubjects 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. |
Who may qualify
- Ages
- 25 to 65 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Patients who have moderate lentigines and/or photodamage and desire laser toning.
- Females 25-65 years of age.
- In good health.
- Have Fitzpatrick phototype I-III.
- Willingness and the ability to understand and provide informed consent and communicate with the investigator/study staff.
Key exclusion criteria (21 listed)
- 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).
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 |
|---|---|---|
| lidocaine 2.5%/prilocaine 2.5% topical anesthetic | Drug | lidocaine 2.5%/prilocaine 2.5% topical anesthetic |
| lidocaine 7%/tetracaine 7% topical anesthetic | Drug | lidocaine 7%/tetracaine 7% topical anesthetic |
| placebo vehicle | Drug | placebo vehicle |
| Q-switched 532nm Laser | Device | lidocaine 2.5%/prilocaine 2.5% topical anesthetic, lidocaine 7%/tetracaine 7% topical anesthetic, placebo vehicle |
Primary outcome
visual analog score (VAS) pain rating
Time frame: Day of treatment
Subjects will fill out a visual analog score (VAS) pain rating after treatment with 0 being no pain and 10 being worst pain
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 1 Jul 2026.
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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.
Murad Alam, MD principal investigator
Northwestern University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Early Phase 1 study testing lidocaine 2.5%/prilocaine 2.5% topical anesthetic, lidocaine 7%/tetracaine 7% topical anesthetic and Q-switched 532nm Laser in people with Lentigo, run by Northwestern University at 1 site in United States.
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 5 inclusion and 21 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 1 Jul 2026. 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 United States. 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. Some participants in this study may receive a placebo. 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?
Early Phase 1 (sometimes called Phase 0) studies give a very small amount of a treatment to a few people, mainly to see how the body handles it.
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?
visual analog score (VAS) pain rating (time frame: Day of treatment). 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 1 Jul 2026.