Healthy VolunteersPhase 1NCT00767676
Contact Sensitization Potential of 828 Ointment
A Phase 1 study testing HP828-101 in people with Healthy Volunteers, run by Healthpoint at 1 site in United States.
Trial summary
Contact sensitization by patch applications. Read more about this study
- Who is it for?
- Ages 18 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Healthy Volunteers
- What is being tested?
- HP828-101
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 259 participants
- Where
- 1 siteUnited States
- Study dates
- Oct 2008to Nov 2008
- Phase
- Phase 1
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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
- Subjects must satisfy all of the following criteria:
- Subjects must be ambulatory, 18 to 65 years of age and in reasonably good health (no physical required).
- Subjects may be of any race or skin type provided their skin pigmentation does not interfere with evaluations.
- Female subjects must be surgically sterile, post-menopausal or using an acceptable method of birth control.
- Minor deviations in normal medical history not considered to be clinically significant by the investigator and the sponsor will be permitted.
- Subjects must refrain from sunbathing, using tanning salons, swimming, or using hot tubs during the entire study.
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- Bathing is permitted but subjects must agree to try and keep the patches as dry as possible.
- Subjects must read and sign the informed consent statement.
- All females of child bearing potential must agree to take an entry and exit urine pregnancy test
Who cannot join
- Subjects with any of the following conditions are not eligible for participation:
- Any systemic disease or disorder, complicating factors or structural abnormality that would negatively affect the conduct or outcome of the study (i.e., hepatitis, acute or chronic renal insufficiency).
- Use of a prescribed pain medication, prescribed or over-the-counter anti-inflammatory drugs, immunosuppressive drugs or prescribed antihistamine medication (steroid nose drops and/or eye drops are permitted). Use of any over-the-counter pain medication that is ingested in quantities exceeding label instructions.
- Subjects who have received an investigational drug or have participated in a Draize type patch test within the past 28 days or who are currently participating in or plan to enter a clinical trial.
- A history of non-compliance or subjects who are considered potentially unreliable.
- A history of skin allergies, including known sensitivity or strong reactions to any cosmetics and/or personal care products, topically prepared medical dressings, tapes, or adhesives.
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- A history of clinically significant skin diseases which may contraindicate participation, including psoriasis, active eczema (at the test sites), atopic dermatitis, and active cancer, even if currently controlled through medication.
- Current use of topical or oral antibiotics.
- Use of topical medications at the test area 2 weeks prior to enrollment or any body lotions/oils/creams at the test area for 48 hours prior to enrollment and throughout the trial.
- Female subjects who are pregnant, stop contraceptive measures, expect to become pregnant or who are breast-feeding.
- Subjects with any condition known to interfere with the absorption, distribution, metabolism, or excretion of drugs.
- Subjects with hematological disorders or immunologic disorders (HIV positive, AIDS, and Systemic Lupus Erythematosus).
- Subjects with any significant organ abnormality or disorders including gastric ulcer/insulin dependent diabetes.
- Subjects with any clinically significant illness (sought medical attention, fever, took prescription medication) within the 4 weeks prior to study entry.
- History of asthma, chronic bronchitis or any other bronchospastic condition that requires medication.
- Anticipated change in the use of a systemic medication during the study that may affect the conduct or outcome of the study. Subjects must be stabilized on these medications for a least one month prior to receiving study drug and continue same regimen throughout the study.
- Bilateral mastectomy for cancer involving removal of lymph nodes.
- Treatment of any type of cancer within the last six months.
- The Investigator may declare any subject ineligible for a sound medical reason.
- Subjects with allergies/known sensitivities to any of the ingredients of the test article.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Evaluation of the Contact Sensitization Potential of 828 Ointment in Normal Healthy Adults
Contact sensitization by patch applications.
Read the detailed description
Single site study that will evaluate the contact sensitization potential of 828 ointment by repetitive patch applications to the skin of normal, healthy volunteers.
- Conditions
- Healthy Volunteers
- Being tested
- HP828-101
- Keywords
- Contact sensitization, Healthy Adult Volunteers
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
HP828-101Device
Nine topical patch applications over 3 weeks, rest period of 2 weeks and challenge after 48 hours.
| Study group | Role | What they receive |
|---|---|---|
| 1 | Other | Not described Receives: Device: HP828-101 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of Participants That Exhibited a Score Less Than 1.5 on the Jordan-King Scale
To qualify for the claim of a reduced sensitization potential, all subjects completing the study could exhibit a value of no more than 1.5 on the Jordan-King Scale [scale is 0 (no visible reaction) to 5 (severe erythema)]
No statistical analyses were performed.
Measured: 7 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Oct 2008 (estimated)
- Study startOct 2008
- Primary completionNov 2008
- Study completionNov 2008
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Healthy VolunteersStudies 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
- Non-randomised
- Intervention model
- Single group
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 259 participants (actual)
Sponsor and investigators
- Lead sponsor
- Healthpoint
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Herbert B Slade, MD, Study chair, HealthpointInnes Cargill, PhD, Study director, Healthpoint
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00767676
- Sponsor's protocol ID
- 828-101-09-011
- Status last verified
- Jun 2014
- First submitted
- 4 Oct 2008
- Last updated
- 27 Jun 2014
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 27 Jun 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of the Contact Sensitization Potential of 828 Ointment in Normal Healthy Adults
- ClinicalTrials.gov ID
- NCT00767676
- Acronym / sponsor ID
- 828-101-09-011
- Conditions
- Healthy Volunteers
- Keywords
- Contact sensitization, Healthy Adult Volunteers
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 259 participants (actual)
- Lead sponsor
- HealthpointIndustry (pharma, biotech, devices)
- Study start
- Oct 2008
- Primary completion
- Nov 2008 (actual)
- Study completion
- Nov 2008 (actual)
- First posted
- 7 Oct 2008 (estimated)
- Results
- Posted 27 Jun 2014
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Contact sensitization by patch applications.
Detailed description
Single site study that will evaluate the contact sensitization potential of 828 ointment by repetitive patch applications to the skin of normal, healthy volunteers.
Study design
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| 1 | Other | Device: HP828-101 |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- Subjects must be ambulatory, 18 to 65 years of age and in reasonably good health (no physical required).
- Subjects may be of any race or skin type provided their skin pigmentation does not interfere with evaluations.
- Female subjects must be surgically sterile, post-menopausal or using an acceptable method of birth control.
- Minor deviations in normal medical history not considered to be clinically significant by the investigator and the sponsor will be permitted.
- Subjects must refrain from sunbathing, using tanning salons, swimming, or using hot tubs during the entire study.
Key exclusion criteria (20 listed)
- Any systemic disease or disorder, complicating factors or structural abnormality that would negatively affect the conduct or outcome of the study (i.e., hepatitis, acute or chronic renal insufficiency).
- Use of a prescribed pain medication, prescribed or over-the-counter anti-inflammatory drugs, immunosuppressive drugs or prescribed antihistamine medication (steroid nose drops and/or eye drops are permitted). Use of any over-the-counter pain medication that is ingested in quantities exceeding label instructions.
- Subjects who have received an investigational drug or have participated in a Draize type patch test within the past 28 days or who are currently participating in or plan to enter a clinical trial.
- A history of non-compliance or subjects who are considered potentially unreliable.
- A history of skin allergies, including known sensitivity or strong reactions to any cosmetics and/or personal care products, topically prepared medical dressings, tapes, or adhesives.
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 |
|---|---|---|
| HP828-101Nine topical patch applications over 3 weeks, rest period of 2 weeks and challenge after 48 hours. | Device | 1 |
Primary outcome
Number of Participants That Exhibited a Score Less Than 1.5 on the Jordan-King Scale
Time frame: 7 weeks
To qualify for the claim of a reduced sensitization potential, all subjects completing the study could exhibit a value of no more than 1.5 on the Jordan-King Scale [scale is 0 (no visible reaction) to 5 (severe erythema)] No statistical analyses were performed.
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Jun 2014.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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Screening Protocol
Pain
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.
Herbert B Slade, MD study chair
Healthpoint
Innes Cargill, PhD study director
Healthpoint
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 HP828-101 in people with Healthy Volunteers, run by Healthpoint 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 20 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 27 Jun 2014. 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?
Yes. Results are posted in the registry (first posted 27 Jun 2014). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Number of Participants That Exhibited a Score Less Than 1.5 on the Jordan-King Scale (time frame: 7 weeks). 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 27 Jun 2014.