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Topical Safety Study of Topical Diltiazem Hydrochloride

Information source: Ventrus Biosciences, Inc
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Diltiazem Skin Sensitivity.

Intervention: Diltiazem Hydrochloride 2% Cream (Drug); Vehicle Cream (Drug); 0.1% solution of sodium lauryl sulfate (SLS) (Drug); Saline (0.9%) (Drug)

Phase: Phase 1

Status: Active, not recruiting

Sponsored by: Ventrus Biosciences, Inc

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.

Clinical Details

Official title: A Randomized, Controlled Study to Evaluate the Sensitizing Potential of Diltiazem Hydrochloride 2% Cream in Healthy Subjects Using a Repeat Insult Patch Test Design

Study design: Allocation: Randomized, Endpoint Classification: Safety Study, Intervention Model: Single Group Assignment, Masking: Double Blind (Subject, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Primary outcome: Determine the potential of Diltiazem Hydrochloride 2% Cream to induce sensitization by repeated topical application to the skin of healthy subjects under controlled conditions.

Detailed description: The primary objective of this study will be to determine the potential of Diltiazem Hydrochloride 2% Cream and its vehicle to induce sensitization by repeated topical application to the skin of healthy subjects under controlled conditions. In addition, the irritation potential of the investigational products will be assessed during the Induction Phase and safety will be assessed by evaluation of any adverse events (AEs) reported during the study.

Eligibility

Minimum age: 18 Years. Maximum age: N/A. Gender(s): Both.

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.

Locations and Contacts

TKL Research, Paramus, New Jersey 07652, United States
Additional Information

Starting date: March 2013
Last updated: August 19, 2013

Page last updated: August 23, 2015

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