PainPhase 3NCT00107835
Safety Study of S-Caine Peel (Skin Numbing Cream) Before a Painful Dermatologic Procedure in Adults
A Phase 3 study testing S-Caine™ Peel (lidocaine and tetracaine cream 7%/7%) in people with Pain, run by ZARS Pharma Inc. at 5 sites in United States.
Trial summary
The purpose of this study is to evaluate the safety of one treatment of S-Caine™ Peel (skin numbing cream) applied on healthy skin before a painful dermatologic procedure in adults. This study will also evaluate how well the S-Caine™ Peel eases the pain of the procedure. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Pain
- What is being tested?
- S-Caine™ Peel (lidocaine and tetracaine cream 7%/7%)
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 408 participants
- Where
- 5 sitesUnited States
- Study dates
- May 2005to Sep 2005
- Phase
- Phase 3
- 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
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patient is 18 years of age or older.
- Patient elects to undergo a minor or major dermal procedure.
- Patient is able to read and understand a written informed consent and has signed and dated a written informed consent.
Who cannot join
- Patient has known allergies, contraindications or sensitivities to lidocaine, tetracaine, or other local anesthetics of the amide or ester type or to any components of the test materials.
- Patient has known active atopic dermatitis at the designated treatment site.
- Patient has damaged, denuded or broken skin at the designated treatment site.
- Patient is pregnant or breastfeeding.
- Patient has participated in an investigational study or clinical trial of an unapproved drug within the previous 30 days.
- Patient has enrolled in any previous study involving S-Caine Peel.
Trial locations and contacts
5 sites in 1 country.
5 sites in 1 country
United States5 sites
Midwest Cutaneous Research
Clinton Township, Michigan, 48038
Texas Dermatology Research Institute
Dallas, Texas, 75230
International Dermatology Research Inc.
Miami, Florida, 33144
Tennessee Clinical Research Center
Nashville, Tennessee, 37215
Laser and Skin Surgery Center of New York
New York, New York, 10016
About this study
Official title: An Open-Label Safety Study to Evaluate the Use of S-Caine™ Peel (Lidocaine 7% and Tetracaine 7% Cream) in Adult Patients Undergoing a Minor or Major Dermal Procedure
The purpose of this study is to evaluate the safety of one treatment of S-Caine™ Peel (skin numbing cream) applied on healthy skin before a painful dermatologic procedure in adults. This study will also evaluate how well the S-Caine™ Peel eases the pain of the procedure.
Read the detailed description
The practice of dermatology is seeing a rise in the number of surgical and laser procedures as technological advances have expanded the number of conditions amenable to these evolving therapies. Skin biopsies, shave excisions, deep excisions, electro-surgical procedures, intralesional injections, and laser surgery are frequently performed by dermatologists on a daily basis. Some pain accompanies almost all of these procedures, and a local anesthetic is commonly used. Traditionally, intracutaneous injection of lidocaine (with or without epinephrine) has been the anesthetic of choice. However, patients undergoing these procedures are often afraid of needles and syringes and the pain associated with injections. As a result, topical anesthetic agents have been explored and developed as painless alternatives to injected anesthesia.
S-Caine™ Peel (lidocaine 7% and tetracaine 7% cream) consists of a new eutectic formulation of lidocaine and tetracaine. S-Caine Peel is a topical local anesthetic cream that forms a pliable peel on the skin when exposed to air. S-Caine Peel is not occluded during application.
The purpose of this study is to gain additional safety information for S-Caine Peel when used in minor and major dermal procedures in adults.
- Conditions
- Pain
- Being tested
- S-Caine™ Peel (lidocaine and tetracaine cream 7%/7%)
- Keywords
- Pain
- Medical subject headings
- Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
S-Caine™ Peel (lidocaine and tetracaine cream 7%/7%)Drug
Also called Pliaglis
S-Caine Peel comprising a 1:1 eutectic mixture of 7% lidocaine, and 7% tetracaine was applied topically. The study drug remained on the treatment area for 20-30 minutes for minor dermal procedures and 60 minutes for major dermal procedures
| Study group | Role | What they receive |
|---|---|---|
| S-Caine Peel | Experimental | Not described Receives: Drug: S-Caine™ Peel (lidocaine and tetracaine cream 7%/7%) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of participants with adverse events
To evaluate the safety of a single administration of S-Caine Peel in providing dermal anesthesia over intact skin prior to a minor and major dermal procedure in adults
Measured: 20-30 minutes
Secondary outcomes (1)
Adequacy of Anesthesia
To evaluate the adequacy of anesthesia provided for the minor and major dermal procedure. The adequacy of anesthesia was evaluated by asking patients whether the study drug provided adequate pain relief for the procedure (yes or no), and by asking the investigator whether the study drug provided adequate anesthesia for the procedure (yes or no).
Measured: 20-30 minutes
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Apr 2005 (estimated)
- Study startMay 2005
- Primary completionSep 2005
- Study completionSep 2005
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for PainStudies 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 3
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 408 participants (actual)
Sponsor and investigators
- Lead sponsor
- ZARS Pharma Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Alicia Barba, MD, Principal investigator, International Dermatology Research, Inc.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00107835
- Sponsor's protocol ID
- SCP-45-05
- Status last verified
- Jun 2012
- First submitted
- 8 Apr 2005
- Last updated
- 6 Jun 2012
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 6 Jun 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Open-Label Safety Study to Evaluate the Use of S-Caine™ Peel (Lidocaine 7% and Tetracaine 7% Cream) in Adult Patients Undergoing a Minor or Major Dermal Procedure
- ClinicalTrials.gov ID
- NCT00107835
- Acronym / sponsor ID
- SCP-45-05
- Conditions
- Pain
- Keywords
- Pain
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 408 participants (actual)
- Lead sponsor
- ZARS Pharma Inc.Industry (pharma, biotech, devices)
- Study start
- May 2005
- Primary completion
- Sep 2005 (actual)
- Study completion
- Sep 2005 (actual)
- First posted
- 11 Apr 2005 (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 evaluate the safety of one treatment of S-Caine™ Peel (skin numbing cream) applied on healthy skin before a painful dermatologic procedure in adults. This study will also evaluate how well the S-Caine™ Peel eases the pain of the procedure.
Detailed description
The practice of dermatology is seeing a rise in the number of surgical and laser procedures as technological advances have expanded the number of conditions amenable to these evolving therapies. Skin biopsies, shave excisions, deep excisions, electro-surgical procedures, intralesional injections, and laser surgery are frequently performed by dermatologists on a daily basis. Some pain accompanies almost all of these procedures, and a local anesthetic is commonly used. Traditionally, intracutaneous injection of lidocaine (with or without epinephrine) has been the anesthetic of choice. However, patients undergoing these procedures are often afraid of needles and syringes and the pain associated with injections. As a result, topical anesthetic agents have been explored and developed as painless alternatives to injected anesthesia.
S-Caine™ Peel (lidocaine 7% and tetracaine 7% cream) consists of a new eutectic formulation of lidocaine and tetracaine. S-Caine Peel is a topical local anesthetic cream that forms a pliable peel on the skin when exposed to air. S-Caine Peel is not occluded during application.
The purpose of this study is to gain additional safety information for S-Caine Peel when used in minor and major dermal procedures in adults.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| S-Caine Peel | Experimental | Drug: S-Caine™ Peel (lidocaine and tetracaine cream 7%/7%) |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Patient is 18 years of age or older.
- Patient elects to undergo a minor or major dermal procedure.
- Patient is able to read and understand a written informed consent and has signed and dated a written informed consent.
Key exclusion criteria (6 listed)
- Patient has known allergies, contraindications or sensitivities to lidocaine, tetracaine, or other local anesthetics of the amide or ester type or to any components of the test materials.
- Patient has known active atopic dermatitis at the designated treatment site.
- Patient has damaged, denuded or broken skin at the designated treatment site.
- Patient is pregnant or breastfeeding.
- Patient has participated in an investigational study or clinical trial of an unapproved drug within the previous 30 days.
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 |
|---|---|---|
| S-Caine™ Peel (lidocaine and tetracaine cream 7%/7%)Also: PliaglisS-Caine Peel comprising a 1:1 eutectic mixture of 7% lidocaine, and 7% tetracaine was applied topically. The study drug remained on the treatment area for 20-30 minutes for minor dermal procedures and 60 minutes for major dermal procedures | Drug | S-Caine Peel |
Primary outcome
Number of participants with adverse events
Time frame: 20-30 minutes
To evaluate the safety of a single administration of S-Caine Peel in providing dermal anesthesia over intact skin prior to a minor and major dermal procedure in adults
1 secondary outcome
Adequacy of Anesthesia
Time frame: 20-30 minutes
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 6 Jun 2012.
- PainLink provided by the sponsor.
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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.
Alicia Barba, MD principal investigator
International Dermatology Research, Inc.
5 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing S-Caine™ Peel (lidocaine and tetracaine cream 7%/7%) in people with Pain, run by ZARS Pharma Inc. at 5 sites 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 3 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 6 Jun 2012. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 5 sites 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. 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 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
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?
Number of participants with adverse events (time frame: 20-30 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 6 Jun 2012.