Healthy VolunteersPhase 1NCT00767455
Cumulative Irritation 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
Cumulative Irritation Patch Test 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?
- Yes, some participants may receive a placebo
- How many people
- 59 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.
- Subjects may be of any ethnicity 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 and all females of childbirth potential must be willing to take a urine pregnancy test at the beginning and at the end of the study.
- 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 course of the study.
- Bathing is permitted, however, subjects must agree to attempt to keep the patches as dry as possible.
- Subjects must read and sign an IRB approved informed consent form.
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 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.
Show all 20Show fewer
- A history of clinically significant skin diseases which may contraindicate participation, including psoriasis, active eczema, 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.
- Known history of either real or suspected allergy or sensitization to any test article ingredient.
- 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 at least one month prior to receiving study drug and continue the same regimen throughout the study.
- Bilateral mastectomy involving removal of lymph nodes.
- Treatment of any type of cancer within the last six months.
- The Principal Investigator may declare any subject ineligible for a sound medical reason.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Evaluation of the Cumulative Irritation Potential of 828 Ointment in a Population of Normal Healthy Subjects
Cumulative Irritation Patch Test
Read the detailed description
Single site study that will evaluate the relative cumulative irritation potential of HP828-101 ointment compared to a negative control, Johnson's baby oil, and a positive control, 0.2% SLS v/v, following 21 daily applications to the skin of normal, healthy volunteers.
- Conditions
- Healthy Volunteers
- Being tested
- HP828-101
- Keywords
- cumulative irritation, healthy adult volunteers
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
HP828-101Device
21 day patches
| Study group | Role | What they receive |
|---|---|---|
| Positive, Negative Controls | Sham comparator | Not described Receives: Device: HP828-101 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Presence of Cumulative Irritation
Irritancy of each test article was evaluated by assessment of the application sites using the Berger and Bowman Scale. Observed responses (e.g., erythema and edema) were graded according to the protocol-specified grading scale [0 (no visible reaction) to 4 (severe erythema)] for each subject. The relative cumulative irritation potentials of the test article (HP828-101 Ointment) and the negative and positive controls were determined by summing the daily scores of the 21 days of testing; with an overall scale of 0 (no visible reaction from any subjects over the 21 days) to 3360 (severe erythema experienced by every subject over the 21 days).
Measured: 22 days
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
- Randomised
- Intervention model
- Single group
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 59 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
- NCT00767455
- Sponsor's protocol ID
- 828-101-09-010
- Status last verified
- Jan 2014
- First submitted
- 4 Oct 2008
- Last updated
- 14 Mar 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 14 Mar 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of the Cumulative Irritation Potential of 828 Ointment in a Population of Normal Healthy Subjects
- ClinicalTrials.gov ID
- NCT00767455
- Acronym / sponsor ID
- 828-101-09-010
- Conditions
- Healthy Volunteers
- Keywords
- cumulative irritation, healthy adult volunteers
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 59 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 14 Mar 2014
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Cumulative Irritation Patch Test
Detailed description
Single site study that will evaluate the relative cumulative irritation potential of HP828-101 ointment compared to a negative control, Johnson's baby oil, and a positive control, 0.2% SLS v/v, following 21 daily applications to the skin of normal, healthy volunteers.
Study design
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Positive, Negative Controls | Sham comparator | Device: HP828-101 |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- Subjects must be ambulatory, 18 to 65 years of age and in reasonably good health.
- Subjects may be of any ethnicity 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 and all females of childbirth potential must be willing to take a urine pregnancy test at the beginning and at the end of the study.
- 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 course of the 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 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 |
|---|---|---|
| HP828-10121 day patches | Device | Positive, Negative Controls |
Primary outcome
Presence of Cumulative Irritation
Time frame: 22 days
Irritancy of each test article was evaluated by assessment of the application sites using the Berger and Bowman Scale. Observed responses (e.g., erythema and edema) were graded according to the protocol-specified grading scale [0 (no visible reaction) to 4 (severe erythema)] for each subject. The relative cumulative irritation potentials of the test article (HP828-101 Ointment) and the negative and positive controls were determined by summing the daily scores of the 21 days of testing; with an overall scale of 0 (no visible reaction from any subjects over the 21 days) to 3360 (severe erythema experienced by every subject over the 21 days).
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Mar 2014.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Related trials for Healthy Volunteers
Not yet recruiting
Neuroergonomic Analysis of a Brain-Computer Interface Device (BCI)
Healthy Volunteers - Male and Female
RecruitingPhase 1
First-in-Human Trial to Assess REGN20423 in Healthy Adult Participants and Adult Participants With Atopic Dermatitis
Healthy Volunteer, Atopic Dermatitis
Not yet recruitingObservational study
Establishment of Biobank of Nasal Epithelium Samples From Healthy Volunteers
Healthy
RecruitingObservational study
Improved Methods of Cell Selection for Bone Marrow Transplant Alternatives
Graft-Versus-Host Disease, Graft-versus-leukemia
Not yet recruitingObservational study
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 8 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 14 Mar 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. 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?
Yes. Results are posted in the registry (first posted 14 Mar 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?
Presence of Cumulative Irritation (time frame: 22 days). 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 14 Mar 2014.