A 21-Day Topical Safety Study of Diltiazem Hydrochloride Using a Cumulative Irritant Patch Test Design
NCT ID: NCT01821274
Last Updated: 2013-08-21
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
UNKNOWN
PHASE1
30 participants
INTERVENTIONAL
2013-03-31
2013-09-30
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
In addition, safety will be assessed by evaluation of any adverse events (AEs) reported during the study.
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
RANDOMIZED
SINGLE_GROUP
TREATMENT
TRIPLE
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
topical Diltiazem Hydrochloride 2% Cream
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.
Diltiazem Hydrochloride 2% Cream
0.2 g applied topically to the infrascapular area of the back.
Vehicle Cream
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.
Vehicle Cream
0.2 g (contains no active pharmaceutical ingredient) applied topically to the infrascapular area of the back.
0.2% 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.
0.1% solution o sodium lauryl sulfate (SLS)
0.2 mL applied topically to the infrascapular area of the back will serve as a positive control.
0.9% saline
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.
Saline 0.9%
0.2 mL applied topically to the infrascapular area of the back will serve as a negative control.
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
Diltiazem Hydrochloride 2% Cream
0.2 g applied topically to the infrascapular area of the back.
Vehicle Cream
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)
0.2 mL applied topically to the infrascapular area of the back will serve as a positive control.
Saline 0.9%
0.2 mL applied topically to the infrascapular area of the back will serve as a negative control.
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
* 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
Exclusion Criteria
* 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)
* 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
18 Years
75 Years
ALL
Yes
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
Ventrus Biosciences, Inc
INDUSTRY
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
TKL Research
Paramus, New Jersey, United States
Countries
Review the countries where the study has at least one active or historical site.
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
VEN307-DERM-002
Identifier Type: -
Identifier Source: org_study_id