Healthy VolunteersPhase 1NCT00758433
Civamide Patch Safety, Tolerability and PK Study
A Phase 1 study testing Zucapsaicin in people with Healthy Volunteers, run by Winston Laboratories at 1 site in United States.
Trial summary
To evaluate the tolerability of two different strengths of a Civamide Patch (0.0075% and 0.0150%) compared to the placebo patch and each other in healthy adult volunteers. To assess the pharmacokinetics of civamide and to determine if there is systemic absorption of the drug from civamide patch in a subset of study… Read more about this study
- Who is it for?
- Ages 18 to 60 yearsHealthy volunteers can take part
- Conditions the study is for
- Healthy Volunteers
- What is being tested?
- Zucapsaicin
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 39 participants
- Where
- 1 siteUnited States
- Study dates
- Sep 2008to Apr 2009
- Phase
- 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 18 to 60 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Subject voluntarily agrees to participate in this study and signs an IRB- approved informed consent prior to performing any of the screening procedures.
- Subject is healthy, determined by pre-study medical evaluation medical history, physical examination of the treatment area, and vital signs).
- Males or females between 18 to 60 years of age, inclusive.
- Non-pregnant, non-lactating females of childbearing potential who agree to use medically acceptable forms of birth control (abstinence, hormonal contraceptives, diaphragm with spermicide, condom with spermicide, or intrauterine device) from Screening to Day 10 follow-up or females of nonchildbearing potential (surgically sterile [hysterectomy or bilateral tubal ligation] or post-menopausal ≥ 1 year).
- Subject has a blood pressure reading lower than or equal to 144/92 mmHg.
- Subject has an oral temperature reading lower than 99.6F.
Show all 11Show fewer
- Subjects must have an area of the skin on the abdomen that is without active skin disease, infection, severe erythema, or other compromise in the integrity of the skin at or near the intended treatment area.
- The subject has no visual or motor impairments that will make it difficult to complete the VAS scales or apply the patch.
- Non-smoker as determined by history over the past year.
- Subject has a body mass index (BMI) between 18.5 and 30.5 kg/m2, in pk subset only.
- Subject is willing and able to cooperate to the extent required by the protocol.
Who cannot join
- Subject has known allergy or hypersensitivity to
- a) Civamide, capsicum, or capsaicin-containing products,
- b) any other ingredient of the patch or
- c) adhesives.
- Presence of any cutaneous abnormality or condition that may adversely impact the application of the test patches.
- History of frequent headache or other painful conditions within the past 30 days that has required or is expected to require the chronic use of prescription or over the counter pain relief medications, such as non- steroidal anti-inflammatory agents, including COX-2 inhibitors, systemic opiates or derivatives, or acetaminophen, prior to Day 1 or within 48 hours prior to Day 1.
Show all 18Show fewer
- Use of alcohol or alcohol-containing foods, medications or beverages within 24 hours prior to Day 1 until after the completion of the Study on Day 10.
- Topical use of any moisturizer or medicated products on or near the treatment area within 48 hours of Day 1 until after the completion of the Study on Day 10.
- Topical use of any capsaicin-containing product for 60 days prior to Day 1 until completion of the Study on Day 10.
- Subject has a history of alcohol and/or drug abuse within two years of study entry.
- Female subjects who are breastfeeding.
- Unwilling to maintain usual consumption of caffeine containing beverages within 24 hours prior to Day -1 until completion of Day 8.
- Subject is unwilling to abstain from vigorous exercise for 48 hours prior to Day 1 until completion of the Study on Day 10.
- Subject is unwilling to abstain from swimming, baths and prolonged with direct stream of water when showering from Day 1 until Day 8
- Use of an investigational drug within 30 days prior to Day 1.
- Donation of blood (> 250 ml) or blood products within 2 months (56 days) prior to Day 1.
- Ingestion of any capsaicin-containing foods for 24 hours before Day 1 and during the study.
- If for any other reason the subject is not deemed to be healthy by the investigator.
Trial locations and contacts
1 site in 1 country.
United States1 site
International Research Services, Inc.
Port Chester, New York, 10573
About this study
Official title: Randomized, Double-Blind, Placebo-Controlled Evaluation of the Tolerability of Two Civamide (Zucapsaicin) Patch Strengths Compared to Placebo Patch in Healthy Volunteers
To evaluate the tolerability of two different strengths of a Civamide Patch (0.0075% and 0.0150%) compared to the placebo patch and each other in healthy adult volunteers. To assess the pharmacokinetics of civamide and to determine if there is systemic absorption of the drug from civamide patch in a subset of study subjects.
Read the detailed description
This is a double-blind, randomized study of the tolerability of two different strengths of a Civamide Patch compared to placebo patch. The study consists of a Screening Period (Days -21 to Day 1), a one week Treatment Period (Days 1-8) and a follow-up telephone call to subjects on Day 10.
Pharmacokinetics will be assessed relative to dosing on Day 1, Day 2, and Day 8 in a subset of subjects. Subjects will also rate stinging and burning sensation at the application site during the Treatment Period.
Twenty-four (24) hours after the last patch application, subjects will return to the study site on Day 8. The treatment area will be evaluated by the Study Physician. Subjects will complete a Subject's Global Rating of Stinging and Burning Sensation and a Subject's Global Rating of Tolerability.
- Conditions
- Healthy Volunteers
- Being tested
- Zucapsaicin, Placebo patch
- Keywords
- Adverse Events, Erythema Rating, Pharmacokinetics, Civamide, Phase 1, Pain, Patch
- Medical subject headings
- Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ZucapsaicinDrug
Also called Civamide
Civamide patch 0.0075% q.d. 24 hours for 7 days
ZucapsaicinDrug
Also called Civamide
Civamide patch 0.0150% q.d. 24 hours for 7 days
Placebo patchDrug
Also called placebo
Placebo patch q.d. 24 hours for 7 days
| Study group | Role | What they receive |
|---|---|---|
| 1 | Active comparator | Civamide patch 0.0075% Receives: Drug: Zucapsaicin |
| 2 | Active comparator | Civamide patch 0.0150% Receives: Drug: Zucapsaicin |
| 3 | Placebo comparator | Placebo patch Receives: Drug: Placebo patch |
What is being measured
The primary outcome is the main question the study is designed to answer.
Subject's Rating of Stinging and Burning Sensation
Measured: 7 Days
Secondary outcomes (1)
Pharmacokinetics
Measured: 7 Days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Sep 2008 (estimated)
- Study startSep 2008
- Primary completionDec 2008
- Study completionApr 2009
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Healthy VolunteersStudies 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 1
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 39 participants (actual)
Sponsor and investigators
- Lead sponsor
- Winston Laboratories
- Sponsor type
- Industry (pharma, biotech, devices)
- Investigators
- Scott B Phillips, M.D., Study director, Winston Laboratories
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00758433
- Sponsor's protocol ID
- WL-1001-04-01
- Status last verified
- Jun 2011
- First submitted
- 23 Sep 2008
- Last updated
- 10 Jun 2011
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 10 Jun 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Randomized, Double-Blind, Placebo-Controlled Evaluation of the Tolerability of Two Civamide (Zucapsaicin) Patch Strengths Compared to Placebo Patch in Healthy Volunteers
- ClinicalTrials.gov ID
- NCT00758433
- Acronym / sponsor ID
- WL-1001-04-01
- Conditions
- Healthy Volunteers
- Keywords
- Adverse Events, Erythema Rating, Pharmacokinetics, Civamide, Phase 1, Pain, Patch
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 39 participants (actual)
- Lead sponsor
- Winston LaboratoriesIndustry (pharma, biotech, devices)
- Study start
- Sep 2008
- Primary completion
- Dec 2008 (actual)
- Study completion
- Apr 2009 (actual)
- First posted
- 25 Sep 2008 (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.
To evaluate the tolerability of two different strengths of a Civamide Patch (0.0075% and 0.0150%) compared to the placebo patch and each other in healthy adult volunteers. To assess the pharmacokinetics of civamide and to determine if there is systemic absorption of the drug from civamide patch in a subset of study subjects.
Detailed description
This is a double-blind, randomized study of the tolerability of two different strengths of a Civamide Patch compared to placebo patch. The study consists of a Screening Period (Days -21 to Day 1), a one week Treatment Period (Days 1-8) and a follow-up telephone call to subjects on Day 10.
Pharmacokinetics will be assessed relative to dosing on Day 1, Day 2, and Day 8 in a subset of subjects. Subjects will also rate stinging and burning sensation at the application site during the Treatment Period.
Twenty-four (24) hours after the last patch application, subjects will return to the study site on Day 8. The treatment area will be evaluated by the Study Physician. Subjects will complete a Subject's Global Rating of Stinging and Burning Sensation and a Subject's Global Rating of Tolerability.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| 1 | Active comparator | Drug: ZucapsaicinCivamide patch 0.0075% |
| 2 | Active comparator | Drug: ZucapsaicinCivamide patch 0.0150% |
| 3 | Placebo comparator | Drug: Placebo patchPlacebo patch |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (11 listed)
- Subject voluntarily agrees to participate in this study and signs an IRB- approved informed consent prior to performing any of the screening procedures.
- Subject is healthy, determined by pre-study medical evaluation medical history, physical examination of the treatment area, and vital signs).
- Males or females between 18 to 60 years of age, inclusive.
- Non-pregnant, non-lactating females of childbearing potential who agree to use medically acceptable forms of birth control (abstinence, hormonal contraceptives, diaphragm with spermicide, condom with spermicide, or intrauterine device) from Screening to Day 10 follow-up or females of nonchildbearing potential (surgically sterile [hysterectomy or bilateral tubal ligation] or post-menopausal ≥ 1 year).
- Subject has a blood pressure reading lower than or equal to 144/92 mmHg.
Key exclusion criteria (18 listed)
- Subject has known allergy or hypersensitivity to
- Presence of any cutaneous abnormality or condition that may adversely impact the application of the test patches.
- History of frequent headache or other painful conditions within the past 30 days that has required or is expected to require the chronic use of prescription or over the counter pain relief medications, such as non- steroidal anti-inflammatory agents, including COX-2 inhibitors, systemic opiates or derivatives, or acetaminophen, prior to Day 1 or within 48 hours prior to Day 1.
- Use of alcohol or alcohol-containing foods, medications or beverages within 24 hours prior to Day 1 until after the completion of the Study on Day 10.
- Topical use of any moisturizer or medicated products on or near the treatment area within 48 hours of Day 1 until after the completion of the Study on Day 10.
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 |
|---|---|---|
| ZucapsaicinAlso: CivamideCivamide patch 0.0075% q.d. 24 hours for 7 days | Drug | 1 |
| ZucapsaicinAlso: CivamideCivamide patch 0.0150% q.d. 24 hours for 7 days | Drug | 2 |
| Placebo patchAlso: placeboPlacebo patch q.d. 24 hours for 7 days | Drug | 3 |
Primary outcome
Subject's Rating of Stinging and Burning Sensation
Time frame: 7 Days
1 secondary outcome
Pharmacokinetics
Time frame: 7 Days
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 10 Jun 2011.
Related trials for Healthy Volunteers
RecruitingObservational study
Development of Magnetic Resonance Imaging Techniques for Studying Mood and Anxiety Disorders
Mood Disorders, Anxiety Disorders
Not yet recruiting
Positron Emission Tomography and Organ-Specific Changes in Participants Co-Enrolled in NIH Studies of Plasmodium Vivax Controlled Human Malaria Infection
Healthy Volunteer, Malaria
RecruitingPhase 1
A Single Ascending Dose Study of DTI-117 Given Intramuscularly in Healthy Participants.
Healthy Adult
RecruitingObservational study
Collection of Lung Fluid and Tissue Samples for Research
Leukocyte Disorders, Respiratory Tract Diseases
Not yet recruitingPhase 2
Effects of Meal Macronutrients on Postprandial Lipids
Nephrotic Syndrome, Lipodystrophy
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.
Scott B Phillips, M.D. study director
Winston Laboratories
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Zucapsaicin in people with Healthy Volunteers, run by Winston Laboratories 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 11 inclusion and 18 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 10 Jun 2011. 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?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
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?
Subject's Rating of Stinging and Burning Sensation (time frame: 7 Days). 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 10 Jun 2011.