HealthyPhase 1NCT00865267
The Dose-response Study of Topically Delivered Halobetasol Propionate Ointment in Normal Skin in Healthy Adult Subjects
A Phase 1 study testing Ultravate® 0.05% ointment, single exposure in people with Healthy, run by Actavis Inc. at 1 site in United States.
Trial summary
The purpose of this study is to determine the duration of application of halobetasol propionate 0.05% ointment to be used in a definitive study of bioequivalence of to formulations of this ointment. Part A: To validate vasoconstrictor assay precision. Read more about this study
- Who is it for?
- Ages 18 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Healthy
- What is being tested?
- Ultravate® 0.05% ointment, single exposure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 1 siteUnited States
- Study dates
- Dec 2003to Dec 2003
- 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 to 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Subject understands the study, is willing to participate, and gives written informed consent.
- Subject demonstrates adequate vasoconstriction to the screening topical corticosteroid Halobetasol propionate 0.05% Ointment.
- Subject is a non-smoking (minimum of 14 days), male or female, ages of 18 - 65 years, inclusive.
- Subject is within 20% of their ideal body weight as defined by the 1999 Metropolitan Life Insurance Company Height and Weight Tables.
- Subject is judged by the Investigator to be healthy on the basis of pre-study medical history.
- Subjects of child-bearing potential agree to use an acceptable method of birth control during study participation (e.g. abstinence, any prescribed birth control method, double barrier method, Le. condom plus foam, condom plus diaphragm).
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- Subject is willing to refrain from excessive consumption of sodium in food or beverage 48hrs before and for the duration of the study.
- Subject is willing to shower using the same soap/cleansers for the duration of the study.
- Subject is willing to follow study restrictions.
Who cannot join
- Subject has a past or current medical condition that might significantly affect pharmacodynamic response to topical corticosteroids.
- Subject has clinically significant hypertension or circulatory disease.
- Subject is taking any medication on a regular basis that could modulate blood flow (constrictor or dilator), with the exception of any prescribed birth control method and hormone replacement therapy. Examples of such drugs include nitroglycerin, anti-hypertensives, antihistamines, NSAIDs, aspirin, phenylpropanolamine, or phentolamine.
- Subject is planning to use any exclusionary over-the-counter (OTC) medications within 48 hours prior to or throughout the study that could modulate blood.
- Subject has a history of sensitivity/allergy to the ingredients found in the test formulations or has a history of adverse reactions to topical or systemic corticosteroids.
- Subject has a significant history of allergy to soaps, lotions, emollients, creams, ointments, cosmetics, adhesives, or latex.
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- Subject has a history of significant skin conditions or disorders, for example, psoriasis, atopic dermatitis, actinic keratosis, etc.
- Subject has an obvious difference In skin color between arms or the presence of a skin condition, scar tissue, tattoo or coloration that would interfere with placement of test sites, their assessments or could compromise the safety of the subject.
- Subject has used topical medications on the ventral forearms within 1 month prior to dosing.
- Subject has used a tobacco product within 14 days of study conduct.
- Subject has a clinically significant history of drug abuse or alcoholism.
- Subject has donated or received blood within 30 days prior to dosing.
- Subject's caffeine intake is greater than 500 mg per day (1 cup of coffee contains approximately 85 mg of caffeine).
- Subject plans consumption of alcohol, or consumption of caffeine within 48 hours of study conduct or throughout the entire dosing and evaluation period of the study.
- (Females only): Subject is pregnant or lactating.
- Subject has participated in another investigational drug, medical device, or biologics study within 30 days prior to dosing.
- formed on all females).
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Single-blind, Single Exposure Study, to Evaluate the Vasoconstriction Activity of Topically Delivered Halobetasol Propionate Ointment in Normal Skin in Healthy Adult Subjects: Dose Ranging Study
The purpose of this study is to determine the duration of application of halobetasol propionate 0.05% ointment to be used in a definitive study of bioequivalence of to formulations of this ointment.
Part A: To validate vasoconstrictor assay precision.
Part B: To evaluate the dose response vasoconstriction profile of Ultravate® 0.05% ointment at different dose durations over a short period of time (0.17 - 4 hrs).
Read the detailed description
Study Type: Interventional Study Design: A single blind, single-exposure study on healthy adult male and female subjects.
Official Title: A Single-blind, Single Exposure Study, to Evaluate the Vasoconstriction Activity of Topically Delivered Halobetasol Propionate Ointment in Normal Skin in Healthy Adult Subjects: Dose Ranging Study
Further study details as provided by Actavis Elizabeth LLC:
Primary Outcome Measures:
Vasoconstrictor Response
- Conditions
- Healthy
- Being tested
- Ultravate® 0.05% ointment, single exposure
- Keywords
- Vasoconstriction, Halobetasol, Healthy adult subjects
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Ultravate® 0.05% ointment, single exposureDrug
Also called Halobetasol
A: Experimental Subjects received Bristol-Myers Squibb Company formulated products
| Study group | Role | What they receive |
|---|---|---|
| A | Experimental | Ultravate® 0.05% ointment, single exposure Receives: Drug: Ultravate® 0.05% ointment, single exposure |
What is being measured
The primary outcome is the main question the study is designed to answer.
Vasoconstriction response
Measured: 36 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Mar 2009 (estimated)
- Study startDec 2003
- Primary completionDec 2003
- Study completionDec 2003
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HealthyStudies 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
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 20 participants (actual)
Sponsor and investigators
- Lead sponsor
- Actavis Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Investigators
- Paul A. Lehman,, M.Sc., Principal investigator, DermTech International
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00865267
- Sponsor's protocol ID
- DP03-685
- Status last verified
- Aug 2010
- First submitted
- 17 Mar 2009
- Last updated
- 17 Aug 2010
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 17 Aug 2010. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Single-blind, Single Exposure Study, to Evaluate the Vasoconstriction Activity of Topically Delivered Halobetasol Propionate Ointment in Normal Skin in Healthy Adult Subjects: Dose Ranging Study
- ClinicalTrials.gov ID
- NCT00865267
- Acronym / sponsor ID
- DP03-685
- Conditions
- Healthy
- Keywords
- Vasoconstriction, Halobetasol, Healthy adult subjects
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 20 participants (actual)
- Lead sponsor
- Actavis Inc.Industry (pharma, biotech, devices)
- Study start
- Dec 2003
- Primary completion
- Dec 2003 (actual)
- Study completion
- Dec 2003 (actual)
- First posted
- 19 Mar 2009 (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.
The purpose of this study is to determine the duration of application of halobetasol propionate 0.05% ointment to be used in a definitive study of bioequivalence of to formulations of this ointment.
Part A: To validate vasoconstrictor assay precision.
Part B: To evaluate the dose response vasoconstriction profile of Ultravate® 0.05% ointment at different dose durations over a short period of time (0.17 - 4 hrs).
Detailed description
Study Type: Interventional Study Design: A single blind, single-exposure study on healthy adult male and female subjects.
Official Title: A Single-blind, Single Exposure Study, to Evaluate the Vasoconstriction Activity of Topically Delivered Halobetasol Propionate Ointment in Normal Skin in Healthy Adult Subjects: Dose Ranging Study
Further study details as provided by Actavis Elizabeth LLC:
Primary Outcome Measures:
Vasoconstrictor Response
Study design
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- Single blind (participant)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| A | Experimental | Drug: Ultravate® 0.05% ointment, single exposureUltravate® 0.05% ointment, single exposure |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- Subject understands the study, is willing to participate, and gives written informed consent.
- Subject demonstrates adequate vasoconstriction to the screening topical corticosteroid Halobetasol propionate 0.05% Ointment.
- Subject is a non-smoking (minimum of 14 days), male or female, ages of 18 - 65 years, inclusive.
- Subject is within 20% of their ideal body weight as defined by the 1999 Metropolitan Life Insurance Company Height and Weight Tables.
- Subject is judged by the Investigator to be healthy on the basis of pre-study medical history.
Key exclusion criteria (17 listed)
- Subject has a past or current medical condition that might significantly affect pharmacodynamic response to topical corticosteroids.
- Subject has clinically significant hypertension or circulatory disease.
- Subject is taking any medication on a regular basis that could modulate blood flow (constrictor or dilator), with the exception of any prescribed birth control method and hormone replacement therapy. Examples of such drugs include nitroglycerin, anti-hypertensives, antihistamines, NSAIDs, aspirin, phenylpropanolamine, or phentolamine.
- Subject is planning to use any exclusionary over-the-counter (OTC) medications within 48 hours prior to or throughout the study that could modulate blood.
- Subject has a history of sensitivity/allergy to the ingredients found in the test formulations or has a history of adverse reactions to topical or systemic corticosteroids.
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 |
|---|---|---|
| Ultravate® 0.05% ointment, single exposureAlso: HalobetasolA: Experimental Subjects received Bristol-Myers Squibb Company formulated products | Drug | A |
Primary outcome
Vasoconstriction response
Time frame: 36 hours
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Aug 2010.
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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.
Paul A. Lehman,, M.Sc. principal investigator
DermTech International
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Ultravate® 0.05% ointment, single exposure in people with Healthy, run by Actavis Inc. at 1 site in United States.
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 9 inclusion and 17 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: finished, as of the sponsor's last update on 17 Aug 2010. 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. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Vasoconstriction response (time frame: 36 hours). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 17 Aug 2010.