- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01821274
A 21-Day Topical Safety Study of Diltiazem Hydrochloride Using a Cumulative Irritant Patch Test Design
August 19, 2013 updated by: Ventrus Biosciences, Inc
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.
Study Overview
Status
Unknown
Conditions
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 Type
Interventional
Enrollment (Anticipated)
30
Phase
- Phase 1
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
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New Jersey
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Paramus, New Jersey, United States, 07652
- TKL Research
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-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
16 years to 73 years (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
Inclusion Criteria:
- 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
Exclusion Criteria:
- 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)
- 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
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Single Group Assignment
- Masking: Triple
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: 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.
|
0.2 g applied topically to the infrascapular area of the back.
|
Placebo Comparator: 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.
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0.2 g (contains no active pharmaceutical ingredient) applied topically to the infrascapular area of the back.
|
Active Comparator: 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.
|
0.2 mL applied topically to the infrascapular area of the back will serve as a positive control.
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Placebo Comparator: 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.
|
0.2 mL applied topically to the infrascapular area of the back will serve as a negative control.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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.
|
21 days
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
March 1, 2013
Primary Completion (Actual)
July 1, 2013
Study Completion (Anticipated)
September 1, 2013
Study Registration Dates
First Submitted
March 26, 2013
First Submitted That Met QC Criteria
March 26, 2013
First Posted (Estimate)
March 29, 2013
Study Record Updates
Last Update Posted (Estimate)
August 21, 2013
Last Update Submitted That Met QC Criteria
August 19, 2013
Last Verified
July 1, 2013
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- VEN307-DERM-002
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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