Overview

Topical Safety Study of Topical Diltiazem Hydrochloride

Status:
Unknown status
Trial end date:
2013-09-01
Target enrollment:
0
Participant gender:
All
Summary
The goal of this study will be to determine the potential of Diltiazem Hydrochloride 2% Cream to induce sensitization by repeated topical application to the skin of healthy subjects under controlled conditions.
Phase:
Phase 1
Accepts Healthy Volunteers?
Accepts Healthy Volunteers
Details
Lead Sponsor:
Ventrus Biosciences, Inc
Treatments:
Diltiazem
Criteria
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;

- In the case of females of childbearing potential: have a negative urine pregnancy test
(UPT) at Screening, and are willing to submit to a pregnancy test at the 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;

- 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 topical/systemic analgesics such as aspirin
(daily use of 81 mg aspirin is acceptable), Aleve, Motrin, Advil, or Nuprin for 72
hours prior to 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 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; and/or

- Have received any investigational treatment(s) within 4 weeks prior to study entry.