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Topical Safety Study of Topical Diltiazem Hydrochloride

Primary Purpose

Diltiazem Skin Sensitivity.

Status
Unknown status
Phase
Phase 1
Locations
United States
Study Type
Interventional
Intervention
Diltiazem Hydrochloride 2% Cream
Vehicle Cream
0.1% solution of sodium lauryl sulfate (SLS)
Saline (0.9%)
Sponsored by
Ventrus Biosciences, Inc
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Diltiazem Skin Sensitivity.

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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.

Sites / Locations

  • TKL Research

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm Type

Experimental

Placebo Comparator

Active Comparator

Placebo Comparator

Arm Label

Topical Diltiazem Hydrochloride 2% Cream

Vehicle Cream

0.1% solution of sodium lauryl sulfate (SLS)

0.9% Saline

Arm Description

0.2 g cream applied topically to the infrascapular area of the back under occlusive patch conditions, 3 times weekly for 3 weeks and one time at Challenge. A total of 10 patch applications over 6-8 weeks.

0.2 g cream applied topically to the infrascapular area of the back under occlusive patch conditions, 3 times weekly for 3 weeks and one time at Challenge. A total of 10 patch applications over 6-8 weeks.

0.2 mL applied topically to the infrascapular area of the back under occlusive patch conditions, 3 times weekly for 3 weeks and one time at Challenge. A total of 10 patch applications over 6-8 weeks.

0.2 mL applied topically to the infrascapular area of the back under occlusive patch conditions, 3 times weekly for 3 weeks and one time at Challenge. A total of 10 patch applications over 6-8 weeks.

Outcomes

Primary Outcome Measures

Determine the potential of Diltiazem Hydrochloride 2% Cream to induce sensitization by repeated topical application to the skin of healthy subjects under controlled conditions.
A total cumulative irritation score for each subject and product will be calculated by summing each individual's scores on each of the 9 evaluation days in the Induction Phase. Cumulative irritancy during Induction will be quantified by means of the cumulative irritancy index (CII), defined as the mean of irritation scores received during the Induction Phase (9 readings). The determination of dermal sensitization potential will be based on specific scoring criteria derived from observations in the Challenge Phase of the study and confirmed in the Rechallenge Phase, if necessary. The recurrence of a cutaneous response at Rechallenge equivalent to or more severe than that observed at challenge will be considered indicative of a sensitization reaction. The observation of such a response in even a single subject suggests that the test product may have the potential to cause hypersensitivity.

Secondary Outcome Measures

Full Information

First Posted
March 18, 2013
Last Updated
August 19, 2013
Sponsor
Ventrus Biosciences, Inc
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1. Study Identification

Unique Protocol Identification Number
NCT01816529
Brief Title
Topical Safety Study of Topical Diltiazem Hydrochloride
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 Type
Interventional

2. Study Status

Record Verification Date
July 2013
Overall Recruitment Status
Unknown status
Study Start Date
March 2013 (undefined)
Primary Completion Date
June 2013 (Actual)
Study Completion Date
September 2013 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Ventrus Biosciences, Inc

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief 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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Diltiazem Skin Sensitivity.

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 1
Interventional Study Model
Single Group Assignment
Masking
ParticipantInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
200 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Topical Diltiazem Hydrochloride 2% Cream
Arm Type
Experimental
Arm Description
0.2 g cream applied topically to the infrascapular area of the back under occlusive patch conditions, 3 times weekly for 3 weeks and one time at Challenge. A total of 10 patch applications over 6-8 weeks.
Arm Title
Vehicle Cream
Arm Type
Placebo Comparator
Arm Description
0.2 g cream applied topically to the infrascapular area of the back under occlusive patch conditions, 3 times weekly for 3 weeks and one time at Challenge. A total of 10 patch applications over 6-8 weeks.
Arm Title
0.1% solution of sodium lauryl sulfate (SLS)
Arm Type
Active Comparator
Arm Description
0.2 mL applied topically to the infrascapular area of the back under occlusive patch conditions, 3 times weekly for 3 weeks and one time at Challenge. A total of 10 patch applications over 6-8 weeks.
Arm Title
0.9% Saline
Arm Type
Placebo Comparator
Arm Description
0.2 mL applied topically to the infrascapular area of the back under occlusive patch conditions, 3 times weekly for 3 weeks and one time at Challenge. A total of 10 patch applications over 6-8 weeks.
Intervention Type
Drug
Intervention Name(s)
Diltiazem Hydrochloride 2% Cream
Intervention Description
0.2 g applied topically to the infrascapular area of the back.
Intervention Type
Drug
Intervention Name(s)
Vehicle Cream
Intervention Description
Vehicle Cream, 0.2 g (contains no active pharmaceutical ingredient) applied topically to the infrascapular area of the back.
Intervention Type
Drug
Intervention Name(s)
0.1% solution of sodium lauryl sulfate (SLS)
Intervention Description
0.2 mL applied topically to the infrascapular area of the back will serve as a positive control.
Intervention Type
Drug
Intervention Name(s)
Saline (0.9%)
Intervention Description
0.2 mL applied topically to the infrascapular area of the back will serve as a negative control.
Primary Outcome Measure Information:
Title
Determine the potential of Diltiazem Hydrochloride 2% Cream to induce sensitization by repeated topical application to the skin of healthy subjects under controlled conditions.
Description
A total cumulative irritation score for each subject and product will be calculated by summing each individual's scores on each of the 9 evaluation days in the Induction Phase. Cumulative irritancy during Induction will be quantified by means of the cumulative irritancy index (CII), defined as the mean of irritation scores received during the Induction Phase (9 readings). The determination of dermal sensitization potential will be based on specific scoring criteria derived from observations in the Challenge Phase of the study and confirmed in the Rechallenge Phase, if necessary. The recurrence of a cutaneous response at Rechallenge equivalent to or more severe than that observed at challenge will be considered indicative of a sensitization reaction. The observation of such a response in even a single subject suggests that the test product may have the potential to cause hypersensitivity.
Time Frame
6 weeks after the first topical application

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility 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.
Facility Information:
Facility Name
TKL Research
City
Paramus
State/Province
New Jersey
ZIP/Postal Code
07652
Country
United States

12. IPD Sharing Statement

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Topical Safety Study of Topical Diltiazem Hydrochloride

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