Skin IrritationPhase 1NCT01821274
A 21-Day Topical Safety Study of Diltiazem Hydrochloride Using a Cumulative Irritant Patch Test Design
A Phase 1 study testing Diltiazem Hydrochloride 2% Cream, 0.1% solution o sodium lauryl sulfate (SLS) and Saline 0.9% in people with Skin Irritation, run by Ventrus Biosciences, Inc at 1 site in United States.
Trial summary
The purpose of the study is to determine whether Diltiazem Hydrochloride 2% Cream will cause irritation to skin on the back of healthy volunteers after repeated application over 21-days. Read more about this study
- Who is it for?
- Ages 18 to 75 yearsHealthy volunteers can take part
- Conditions the study is for
- Skin Irritation
- What is being tested?
- Diltiazem Hydrochloride 2% Cream, 0.1% solution o sodium lauryl sulfate (SLS) and Saline 0.9%
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 30 participants
- Where
- 1 siteUnited States
- Study dates
- Mar 2013to Sep 2013
- 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 75 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Are healthy males or females (to be confirmed by medical history)
- Are 18 years of age or older
- In the case of females of childbearing potential, are using an acceptable form of birth control (oral/implant/injectable/transdermal contraceptives, intrauterine device, condom with spermicide, diaphragm with spermicide, abstinence, partner's vasectomy). Abstinence or vasectomies are acceptable if the female subject agrees to implement one of the other acceptable methods of birth control if her lifestyle/partner changes
- If a female of childbearing potential, have a negative urine pregnancy test (UPT) at Screening, and are willing to submit to a pregnancy test at end of study (EOS)
- Are free of any systemic or dermatologic disorder, which, in the opinion of the investigator, will interfere with the study results or increase the risk of adverse events
- Are of any skin type or race, providing the skin pigmentation will allow discernment of erythema
- Complete a Medical Screening form as well as a Medical Personal History form
- Read, understand, and provide signed informed consent
Who cannot join
- Have sick sinus syndrome except in the presence of a functioning ventricular pacemaker (confirmed via medical history
- Have second-or third-degree AV block except in the presence of a functioning ventricular pacemaker (confirmed via medical history)
- Have hypotension (less than 90 mm Hg systolic, determined by performing vital signs)
- Have acute myocardial infarction and pulmonary congestion documented by x-ray (confirmed via medical history)
- Have any visible skin disease at the application site which, in the opinion of the investigative personnel, will interfere with the evaluation of the test site reaction
- Are not willing to refrain from using systemic/topical analgesics such as aspirin (81 mg daily aspirin will be allowed), Aleve, Motrin, Advil, or Nuprin for 72 hours prior to Day 1 and during the study (occasional use of acetaminophen will be permitted)
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- Are using systemic/topical corticosteroids for 3 weeks prior to and during the study, or systemic/topical antihistamines for 72 hours prior to Day 1 and during the study
- Are using medication which, in the opinion of the investigative personnel, will interfere with the study results, including anti-inflammatory medications
- Are unwilling or unable to refrain from the use of sunscreens, cosmetics, creams, ointments, lotions, or similar products on the back during the study
- Have psoriasis and/or active atopic dermatitis/eczema
- Are females who are pregnant, plan to become pregnant during the study, or are breast-feeding a child
- Have a known sensitivity to constituents present in the material being evaluated
- Have damaged skin in or around the test sites, including sunburn, excessively deep tans, uneven skin tones, tattoos, scars, excessive hair, numerous freckles, or other disfigurations of the test site
- Have received treatment for any type of internal cancer within 5 years prior to study entry
- Have a history of, or are currently being treated for skin cancer
- Are currently participating in any clinical testing
- Have any known sensitivity to adhesives
- Have received any investigational treatment(s) within 4 weeks prior to study entry
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A 21-Day, Randomized, Controlled Study to Evaluate the Irritation Potential of Diltiazem Hydrochloride 2% Cream in Healthy Subjects, Using a Cumulative Irritant Patch Test Design
The purpose of the study is to determine whether Diltiazem Hydrochloride 2% Cream will cause irritation to skin on the back of healthy volunteers after repeated application over 21-days.
Read the detailed description
The primary objective of this study will be to determine the potential of Diltiazem Hydrochloride 2% Cream to cause irritation after repeated topical application to the healthy skin of humans under controlled conditions.
In addition, safety will be assessed by evaluation of any adverse events (AEs) reported during the study.
- Conditions
- Skin Irritation
- Being tested
- Diltiazem Hydrochloride 2% Cream, Vehicle Cream, 0.1% solution o sodium lauryl sulfate (SLS), Saline 0.9%
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Diltiazem Hydrochloride 2% CreamDrug
0.2 g applied topically to the infrascapular area of the back.
Vehicle CreamDrug
0.2 g (contains no active pharmaceutical ingredient) applied topically to the infrascapular area of the back.
0.1% solution o sodium lauryl sulfate (SLS)Drug
0.2 mL applied topically to the infrascapular area of the back will serve as a positive control.
Saline 0.9%Drug
0.2 mL applied topically to the infrascapular area of the back will serve as a negative control.
| Study group | Role | What they receive |
|---|---|---|
| topical Diltiazem Hydrochloride 2% Cream | Experimental | 0.2 g applied topically under occlusive patch conditions to the infrascapular area of the back, once daily for 21 consecutive days over 3 weeks. Receives: Drug: Diltiazem Hydrochloride 2% Cream |
| Vehicle Cream | Placebo comparator | 0.2 g applied topically under occlusive patch conditions to the infrascapular area of the back, once daily for 21 consecutive days over 3 weeks. Receives: Drug: Vehicle Cream |
| 0.2% sodium lauryl sulfate (SLS) | Active comparator | 0.2 mL applied topically under occlusive patch conditions to the infrascapular area of the back once daily for 21 days over 3 weeks, will serve as a positive control. Receives: Drug: 0.1% solution o sodium lauryl sulfate (SLS) |
| 0.9% saline | Placebo comparator | 0.2 mL, applied topically under occlusive patch conditions to the infrascapular area of the back once daily for 21 days over 3 weeks, will serve as a negative control. Receives: Drug: Saline 0.9% |
What is being measured
The primary outcome is the main question the study is designed to answer.
Mean cumulative irritation score of Diltiazem Hydrochloride 2% Cream in healthy skin of humans.
The primary variable of interest is the mean cumulative irritation score. The mean cumulative irritation score for each subject, product and site will be calculated as the sum of the irritation scores divided by the number of readings. The total cumulative irritation score for each subject and product will also be calculated as the sum of irritation scores on each of 21 evaluation days. A normalized total score for each patch will be calculated by summing the total irritation scores for all subjects, dividing by the number of readings and multiplying by 210. These parameters will be tested pairwise for product differences using Fisher's protected least significant differences in the context of the analysis of variance (ANOVA), including effects of subject and product (ie, randomized complete blocks). All pairwise differences will be tested. No adjustment for multiple comparisons will be made.
Measured: 21 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Mar 2013 (estimated)
- Study startMar 2013
- Primary completionJul 2013
- Study completionSep 2013 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Skin IrritationStudies 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Ventrus Biosciences, Inc
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01821274
- Sponsor's protocol ID
- VEN307-DERM-002
- Status last verified
- Jul 2013
- First submitted
- 26 Mar 2013
- Last updated
- 21 Aug 2013
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 21 Aug 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A 21-Day, Randomized, Controlled Study to Evaluate the Irritation Potential of Diltiazem Hydrochloride 2% Cream in Healthy Subjects, Using a Cumulative Irritant Patch Test Design
- ClinicalTrials.gov ID
- NCT01821274
- Acronym / sponsor ID
- VEN307-DERM-002
- Conditions
- Skin Irritation
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- Ventrus Biosciences, IncIndustry (pharma, biotech, devices)
- Study start
- Mar 2013
- Primary completion
- Jul 2013 (actual)
- Study completion
- Sep 2013 (estimated)
- First posted
- 29 Mar 2013 (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 the study is to determine whether Diltiazem Hydrochloride 2% Cream will cause irritation to skin on the back of healthy volunteers after repeated application over 21-days.
Detailed description
The primary objective of this study will be to determine the potential of Diltiazem Hydrochloride 2% Cream to cause irritation after repeated topical application to the healthy skin of humans under controlled conditions.
In addition, safety will be assessed by evaluation of any adverse events (AEs) reported during the study.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| topical Diltiazem Hydrochloride 2% Cream | Experimental | Drug: Diltiazem Hydrochloride 2% Cream0.2 g applied topically under occlusive patch conditions to the infrascapular area of the back, once daily for 21 consecutive days over 3 weeks. |
| Vehicle Cream | Placebo comparator | Drug: Vehicle Cream0.2 g applied topically under occlusive patch conditions to the infrascapular area of the back, once daily for 21 consecutive days over 3 weeks. |
| 0.2% sodium lauryl sulfate (SLS) | Active comparator | Drug: 0.1% solution o sodium lauryl sulfate (SLS)0.2 mL applied topically under occlusive patch conditions to the infrascapular area of the back once daily for 21 days over 3 weeks, will serve as a positive control. |
| 0.9% saline | Placebo comparator | Drug: Saline 0.9%0.2 mL, applied topically under occlusive patch conditions to the infrascapular area of the back once daily for 21 days over 3 weeks, will serve as a negative control. |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- Are healthy males or females (to be confirmed by medical history)
- Are 18 years of age or older
- In the case of females of childbearing potential, are using an acceptable form of birth control (oral/implant/injectable/transdermal contraceptives, intrauterine device, condom with spermicide, diaphragm with spermicide, abstinence, partner's vasectomy). Abstinence or vasectomies are acceptable if the female subject agrees to implement one of the other acceptable methods of birth control if her lifestyle/partner changes
- If a female of childbearing potential, have a negative urine pregnancy test (UPT) at Screening, and are willing to submit to a pregnancy test at end of study (EOS)
- Are free of any systemic or dermatologic disorder, which, in the opinion of the investigator, will interfere with the study results or increase the risk of adverse events
Key exclusion criteria (18 listed)
- Have sick sinus syndrome except in the presence of a functioning ventricular pacemaker (confirmed via medical history
- Have second-or third-degree AV block except in the presence of a functioning ventricular pacemaker (confirmed via medical history)
- Have hypotension (less than 90 mm Hg systolic, determined by performing vital signs)
- Have acute myocardial infarction and pulmonary congestion documented by x-ray (confirmed via medical history)
- Have any visible skin disease at the application site which, in the opinion of the investigative personnel, will interfere with the evaluation of the test site reaction
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 |
|---|---|---|
| Diltiazem Hydrochloride 2% Cream0.2 g applied topically to the infrascapular area of the back. | Drug | topical Diltiazem Hydrochloride 2% Cream |
| Vehicle Cream0.2 g (contains no active pharmaceutical ingredient) applied topically to the infrascapular area of the back. | Drug | Vehicle Cream |
| 0.1% solution o sodium lauryl sulfate (SLS)0.2 mL applied topically to the infrascapular area of the back will serve as a positive control. | Drug | 0.2% sodium lauryl sulfate (SLS) |
| Saline 0.9%0.2 mL applied topically to the infrascapular area of the back will serve as a negative control. | Drug | 0.9% saline |
Primary outcome
Mean cumulative irritation score of Diltiazem Hydrochloride 2% Cream in healthy skin of humans.
Time frame: 21 days
The primary variable of interest is the mean cumulative irritation score. The mean cumulative irritation score for each subject, product and site will be calculated as the sum of the irritation scores divided by the number of readings. The total cumulative irritation score for each subject and product will also be calculated as the sum of irritation scores on each of 21 evaluation days. A normalized total score for each patch will be calculated by summing the total irritation scores for all subjects, dividing by the number of readings and multiplying by 210. These parameters will be tested pairwise for product differences using Fisher's protected least significant differences in the context of the analysis of variance (ANOVA), including effects of subject and product (ie, randomized complete blocks). All pairwise differences will be tested. No adjustment for multiple comparisons will be made.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Aug 2013.
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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.
The record lists no contact. Use the official record to reach the sponsor.
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 Diltiazem Hydrochloride 2% Cream, 0.1% solution o sodium lauryl sulfate (SLS) and Saline 0.9% in people with Skin Irritation, run by Ventrus Biosciences, Inc 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 8 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: status not confirmed, as of the sponsor's last update on 21 Aug 2013. 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?
Results are not available in the source record.
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 cumulative irritation score of Diltiazem Hydrochloride 2% Cream in healthy skin of humans. (time frame: 21 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 21 Aug 2013.