Diltiazem Skin Sensitivity.Phase 1NCT01816529

Topical Safety Study of Topical Diltiazem Hydrochloride

A Phase 1 study testing Diltiazem Hydrochloride 2% Cream, 0.1% solution of sodium lauryl sulfate (SLS) and Saline (0.9%) in people with Diltiazem Skin Sensitivity., run by Ventrus Biosciences, Inc at 1 site in United States.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record

Search all trials

Trial 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. Read more about this study

Who is it for?: Ages 18 years and olderHealthy volunteers can take part
Conditions the study is for: Diltiazem Skin Sensitivity.
What is being tested?: Diltiazem Hydrochloride 2% Cream, 0.1% solution of sodium lauryl sulfate (SLS) and Saline (0.9%)
Could I receive a placebo?: Yes, some participants may receive a placebo
How many people: 200 participants
Where: 1 siteUnited States
Study dates: Mar 2013to Sep 2013
Phase: Phase 1
Are there results?: None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 18 years and older
All sexes
Healthy volunteers accepted
Adult, Older adult

Who may be able to join

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.

Who cannot join

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);

Show all 18Show fewer

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.

Trial locations and contacts

1 site in 1 country.

United States1 site

TKL Research
Paramus, New Jersey, 07652

Other trials in United States

About this study

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

Read the 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.

Conditions: Diltiazem Skin Sensitivity.
Being tested: Diltiazem Hydrochloride 2% Cream, Vehicle Cream, 0.1% solution of sodium lauryl sulfate (SLS), Saline (0.9%)

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Diltiazem Hydrochloride 2% CreamDrug
0.2 g applied topically to the infrascapular area of the back.
Vehicle CreamDrug
Vehicle Cream, 0.2 g (contains no active pharmaceutical ingredient) applied topically to the infrascapular area of the back.
0.1% solution of sodium lauryl sulfate (SLS)Drug
0.2 mL applied topically to the infrascapular area of the back will serve as a positive control.
Saline (0.9%)Drug
0.2 mL applied topically to the infrascapular area of the back will serve as a negative control.

Study groups in NCT01816529
Study group	Role	What they receive
Topical Diltiazem Hydrochloride 2% Cream	Experimental	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. Receives: Drug: Diltiazem Hydrochloride 2% Cream
Vehicle Cream	Placebo comparator	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. Receives: Drug: Vehicle Cream
0.1% solution of sodium lauryl sulfate (SLS)	Active comparator	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. Receives: Drug: 0.1% solution of sodium lauryl sulfate (SLS)
0.9% Saline	Placebo comparator	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. Receives: Drug: Saline (0.9%)

What is being measured

The primary outcome is the main question the study is designed to answer.

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.
Measured: 6 weeks after the first topical application

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

Mar 2013Sep 2013

First posted22 Mar 2013 (estimated)
Study startMar 2013
Primary completionJun 2013
Study completionSep 2013 (estimated)

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Other trials for Diltiazem Skin Sensitivity.Studies of the same condition, open and under way.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase 1
Primary purpose: Treatment
Allocation: Randomised
Intervention model: Single group
Masking: Triple blind
Who is masked: Participant, Investigator, Outcomes assessor
Enrolment: 200 participants (estimated)

IDs, dates and publications

ClinicalTrials.gov ID: NCT01816529
Sponsor's protocol ID: VEN307-DERM-001
Status last verified: Jul 2013
First submitted: 18 Mar 2013
Last updated: 21 Aug 2013
Results posted: No
Data monitoring committee: No

Study at a glance

From the registry record, last updated by the sponsor on 21 Aug 2013. Recruitment status is as the sponsor reported it: confirm with the study team.

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
ClinicalTrials.gov ID: NCT01816529
Acronym / sponsor ID: VEN307-DERM-001
Conditions: Diltiazem Skin Sensitivity.
Phase: Phase 1
Study type: Interventional
Recruitment status: Unknown status
Enrolment: 200 participants (estimated)
Lead sponsor: Ventrus Biosciences, IncIndustry (pharma, biotech, devices)
Study start: Mar 2013
Primary completion: Jun 2013 (actual)
Study completion: Sep 2013 (estimated)
First posted: 22 Mar 2013 (estimated)
Results: Not posted in the source record

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Detailed description

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Single group
Masking: Triple blind (participant, investigator, outcomes assessor)
Number of arms: 4

Arm	Type	Receives
Topical Diltiazem Hydrochloride 2% Cream	Experimental	Drug: Diltiazem Hydrochloride 2% Cream0.2 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.
Vehicle Cream	Placebo comparator	Drug: Vehicle Cream0.2 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.
0.1% solution of sodium lauryl sulfate (SLS)	Active comparator	Drug: 0.1% solution of sodium lauryl sulfate (SLS)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.
0.9% Saline	Placebo comparator	Drug: Saline (0.9%)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.

Who may qualify

Ages: 18 years and older
Sex: All
Healthy volunteers: Accepted
Age groups: Adult, Older adult

Key inclusion criteria (7 listed)

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;

Key exclusion criteria (18 listed)

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;

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
Diltiazem Hydrochloride 2% Cream0.2 g applied topically to the infrascapular area of the back.	Drug	Topical Diltiazem Hydrochloride 2% Cream
Vehicle CreamVehicle Cream, 0.2 g (contains no active pharmaceutical ingredient) applied topically to the infrascapular area of the back.	Drug	Vehicle Cream
0.1% solution of sodium lauryl sulfate (SLS)0.2 mL applied topically to the infrascapular area of the back will serve as a positive control.	Drug	0.1% solution of sodium lauryl sulfate (SLS)
Saline (0.9%)0.2 mL applied topically to the infrascapular area of the back will serve as a negative control.	Drug	0.9% Saline

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.
Time frame: 6 weeks after the first topical application
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.

Results and safety

Results are not available in the source record.

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 21 Aug 2013.

Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

The record lists no contact. Use the official record to reach the sponsor.

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 7 inclusion and 18 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: status not confirmed, as of the sponsor's last update on 21 Aug 2013. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Determine the potential of Diltiazem Hydrochloride 2% Cream to induce sensitization by repeated topical application to the skin of healthy subjects under controlled conditions. (time frame: 6 weeks after the first topical application). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT01816529.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 Aug 2013.