Local AnesthesiaPhase 2NCT01360749
Efficacy and Safety of Lambdalina (Lidocaine Cream) Versus Placebo as an Anesthetic for Laser Hair Removal
A Phase 2 study testing Lambdalina® (Lidocaine 4% cream) in people with Local Anesthesia, run by ISDIN at 2 sites in Spain.
Trial summary
Double-blind, randomized, placebo-controlled trial to assess the efficacy of Lambdalina (lidocaine cream) in reducing pain associated with laser hair removal in women. Read more about this study
- Who is it for?
- Ages 18 to 65 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Local Anesthesia
- What is being tested?
- Lambdalina® (Lidocaine 4% cream)
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 42 participants
- Where
- 2 sitesSpain
- Study dates
- May 2011to Nov 2011
- Phase
- Phase 2
- 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 to 65 years
- Women only
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Women ≥ 18 and ≤ 65 years old.
- Laser hair removal treatment session in the legs in the area from the knee to the ankle (first or second application).
- Able of accomplishing the study's requirements.
- Negative result in the pregnancy test.
- Sterile or surgically sterilized women (hysterectomy, tubal ligation) or using adequate contraceptive methods.
- Written informed consent prior to inclusion in the trial.
Who cannot join
- General exclusion criteria:
- Pregnant or breastfeeding.
- Current or previous medical conditions:
- Skin type 5 or 6 or a history of photosensitivity.
- Cardiovascular diseases such as unstable angina, or severe heart failure (New York Heart Association III or IV).
- Neuropathy or paresthesia.
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- History of hepatic failure.
- Autoimmune diseases.
- Allergies to peanuts and/or soy and/or any components of the formulation.
- Use or dependence on prohibited substances.
- Other contraindications specified in the summary of product characteristics.
- Current or previous concomitant medications:
- Any anesthetic or analgesic treatment during 2 hours prior of study entry.
- Concomitant treatment with antiarrhythmic drugs of class I (eg. tocainide, mexiletine) or class III (eg. amiodarone, sotalol), anticoagulants, anti-platelet aggregating and/or beta-blockers.
- Active wounds or irritations in the area to be treated.
- Topical treatment with corticosteroids or other topical agent in the area to be studied.
Trial locations and contacts
2 sites in 1 country.
Spain2 sites
Clínica Dermatológica Campo De Felipe
Barcelona
Clínica Dermatológica Láser
Madrid
About this study
Official title: Multicentre, Double-Blind Trial to Evaluate the Efficacy and Safety of Lambdalina vs Placebo as an Anesthetic for Laser Hair Removal
Double-blind, randomized, placebo-controlled trial to assess the efficacy of Lambdalina (lidocaine cream) in reducing pain associated with laser hair removal in women.
- Conditions
- Local Anesthesia
- Being tested
- Lambdalina® (Lidocaine 4% cream), Placebo
- Keywords
- Pain management, Lidocaine
- Medical subject headings
- Agnosia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Lambdalina® (Lidocaine 4% cream)Drug
Lambdaline dose: 2 g for 10 cm2.
PlaceboDrug
Placebo dose: 2 g for 10 cm2.
| Study group | Role | What they receive |
|---|---|---|
| Lambdalina and placebo | Experimental | Eligible patients will receive lambdaline (lidocaine cream 40 mg/g) in Left Lower Extremity and placebo in Right Lower Extremity. Receives: Drug: Lambdalina® (Lidocaine 4% cream); Drug: Placebo |
| Placebo and lambdalina | Experimental | Eligible patients will receive placebo in Left Lower Extremity and lambdaline (lidocaine cream 40 mg/g) in Right Lower Extremity. Receives: Drug: Lambdalina® (Lidocaine 4% cream); Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Mean change in pain intensity (Pain Visual Analogue Scale) associated to laser hair removal from baseline to the end of laser hair removal session (primary endpoint)
Measured: 30 minutes after treatment
Secondary outcomes (1)
Safety assessments including AEs and SAEs
Measured: 48 hours after treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 May 2011 (estimated)
- Study startMay 2011
- Primary completionNov 2011
- Study completionNov 2011
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Local AnesthesiaStudies of the same condition, open and under way.
- 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 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 42 participants (actual)
Sponsor and investigators
- Lead sponsor
- ISDIN
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Antonio Campo Voegeli, MD, Study chair, Clínica Dermatológica Campo De Felipe, Barcelona, SpainSerafín Fernández, MD, Principal investigator, Clínica Dermatológica Láser, Madrid, SpainAntonio Campo Voegeli, MD, Principal investigator, Clínica Dermatológica Campo De Felipe, Barcelona, Spain
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01360749
- Sponsor's protocol ID
- ISD-LAM-2010-01
- Status last verified
- Apr 2012
- First submitted
- 24 May 2011
- Last updated
- 13 Apr 2012
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 13 Apr 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Multicentre, Double-Blind Trial to Evaluate the Efficacy and Safety of Lambdalina vs Placebo as an Anesthetic for Laser Hair Removal
- ClinicalTrials.gov ID
- NCT01360749
- Acronym / sponsor ID
- ISD-LAM-2010-01
- Conditions
- Local Anesthesia
- Keywords
- Pain management, Lidocaine
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 42 participants (actual)
- Lead sponsor
- ISDINIndustry (pharma, biotech, devices)
- Study start
- May 2011
- Primary completion
- Nov 2011 (actual)
- Study completion
- Nov 2011 (actual)
- First posted
- 26 May 2011 (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.
Double-blind, randomized, placebo-controlled trial to assess the efficacy of Lambdalina (lidocaine cream) in reducing pain associated with laser hair removal in women.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Lambdalina and placebo | Experimental | Drug: Lambdalina® (Lidocaine 4% cream), Drug: PlaceboEligible patients will receive lambdaline (lidocaine cream 40 mg/g) in Left Lower Extremity and placebo in Right Lower Extremity. |
| Placebo and lambdalina | Experimental | Drug: Lambdalina® (Lidocaine 4% cream), Drug: PlaceboEligible patients will receive placebo in Left Lower Extremity and lambdaline (lidocaine cream 40 mg/g) in Right Lower Extremity. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Women ≥ 18 and ≤ 65 years old.
- Laser hair removal treatment session in the legs in the area from the knee to the ankle (first or second application).
- Able of accomplishing the study's requirements.
- Negative result in the pregnancy test.
- Sterile or surgically sterilized women (hysterectomy, tubal ligation) or using adequate contraceptive methods.
Key exclusion criteria (16 listed)
- General exclusion criteria:
- Pregnant or breastfeeding.
- Skin type 5 or 6 or a history of photosensitivity.
- Cardiovascular diseases such as unstable angina, or severe heart failure (New York Heart Association III or IV).
- Neuropathy or paresthesia.
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 |
|---|---|---|
| Lambdalina® (Lidocaine 4% cream)Lambdaline dose: 2 g for 10 cm2. | Drug | Lambdalina and placebo, Placebo and lambdalina |
| PlaceboPlacebo dose: 2 g for 10 cm2. | Drug | Lambdalina and placebo, Placebo and lambdalina |
Primary outcome
Mean change in pain intensity (Pain Visual Analogue Scale) associated to laser hair removal from baseline to the end of laser hair removal session (primary endpoint)
Time frame: 30 minutes after treatment
1 secondary outcome
Safety assessments including AEs and SAEs
Time frame: 48 hours after treatment
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 13 Apr 2012.
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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.
Antonio Campo Voegeli, MD study chair
Clínica Dermatológica Campo De Felipe, Barcelona, Spain
Serafín Fernández, MD principal investigator
Clínica Dermatológica Láser, Madrid, Spain
Antonio Campo Voegeli, MD principal investigator
Clínica Dermatológica Campo De Felipe, Barcelona, Spain
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Lambdalina® (Lidocaine 4% cream) in people with Local Anesthesia, run by ISDIN at 2 sites in Spain.
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 6 inclusion and 16 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 13 Apr 2012. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Spain. 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 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
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?
Mean change in pain intensity (Pain Visual Analogue Scale) associated to laser hair removal from baseline to the end of laser hair removal session (primary endpoint) (time frame: 30 minutes after 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 13 Apr 2012.