Skin AbnormalitiesEarly Phase 1NCT01108523
Evaluation of Effects of HP828-101 for Moisture Associated Skin Damage
A Early Phase 1 study testing HP828-101 in people with Skin Abnormalities, run by Healthpoint at 1 site in United States.
Trial summary
This study evaluates HP828 in the management of moisture associated skin damage after 15 days of use. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Skin Abnormalities
- 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
- 7 participants
- Where
- 1 siteUnited States
- Study dates
- Apr 2010to Feb 2012
- Phase
- Early 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- - The informed consent document must be read, signed, and dated by the subject or the subject's legally authorized representative before conducting any study procedures or exams. In addition, the informed consent document must be signed and dated by the individual who consents the subject before conducting Visit 1. A photocopy of the signed informed consent document must be provided to the subject or subject representative, and the original signed document placed in the subject's chart. If the subject is unable to read or sign the informed consent, or unable to comprehend the information provided in the consent process, a legal guardian, decision making proxy, or next of kin must provide written consent, and if possible, subject must verbally assent to receiving an experimental treatment for their wound.
- Are 18 years of age or older, of either sex and of any race or skin type provided that their skin color, in the opinion of the Investigator, will not interfere with the study assessments.
- Are expected to remain in the Nursing Home or long-term acute-care (LTAC) for the duration of the study (15 days).
- Have moisture associated skin damage including denuded skin or ulceration, where:
- the damage has been present for at least 2 days but less than 6 weeks
- the area of denudation (target wound) measures greater than or equal to 2 and less than or equal to 64 cm2 in total area
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- the area of total damage may be greater than 64 cm2
- Are able to verbally respond to the Pre- and Post- Treatment Survey.
- Women of child-bearing potential may participate in the study if they have a negative urine pregnancy test and use adequate birth control, as determined by the Investigator.
- Are capable of maintaining adequate nutritional intake during the study
Who cannot join
- Have more than 64 cm2 of denuded area.
- Have a full-thickness target wound, or a full-thickness wound within 4 cm of any target wound area.
- Have clinical evidence of bacterial or fungal infection of the target wound area.
- Have, within the area of moisture damaged skin, any tunneling, sinus tracks, shear injury, arterial occlusive disease, or bony prominence or joint with the exception that target wounds may be over dorsal spinous processes, coccyx, ischial tuberosities, or sacroiliac joints.
- Are moribund, or have a severe burn, debilitating immunodeficiency disorder, significant hematologic disorder, metastatic malignancy, uncontrolled diabetes mellitus, or any medical conditions that, in the opinion of the Investigator, places the subject at risk for the study or incapable of healing.
- Are known to have acrodermatitis enteropathica (zinc deficiency).
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- Are being treated currently with systemic steroids, immunosuppressive agents, radiation, or chemotherapy.
- Have been treated with enzymatic debridement to the target wound area within 2 days prior to enrollment.
- Have a known sensitivity to ingredients of HP828-101.
- Are using or have used another investigational agent (not including devices such as hearing aids, pace makers, etc.) within 30 days prior to Visit 1.
- The Medical Monitor may declare any subject ineligible for a valid medical reason.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Open Label Evaluation of the Effects of HP828-101 in the Management of Moisture Associated Skin Damage in Adults
This study evaluates HP828 in the management of moisture associated skin damage after 15 days of use.
- Conditions
- Skin Abnormalities
- Being tested
- HP828-101
- Keywords
- Moisture Associated Skin Damage
- Medical subject headings
- Skin Abnormalities
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
HP828-101Device
| Study group | Role | What they receive |
|---|---|---|
| HP828-101 | Experimental | HP828-101 Experimental Formulation Receives: Device: HP828-101 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Rating Scores of Skin Erythema, Skin Pallor, Skin Maceration, Skin Denudation at Day 15.
Measured: 15 Days
Secondary outcomes (1)
Rating Scores of Skin Erythema, Skin Pallor, Skin Maceration, Skin Denudation at Day 4, 8, and 12. Proportion of Subjects With no Denuded Skin Area at Day 4, 8, 12, and 15. Pre- and Post-Treatment Surveys
Measured: 4, 8, 12, and 15 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Apr 2010 (estimated)
- Study startApr 2010
- Primary completionJul 2010
- Study completionFeb 2012
Why it stopped: Business decision
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 Skin AbnormalitiesStudies 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
- Early Phase 1
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 7 participants (actual)
Sponsor and investigators
- Lead sponsor
- Healthpoint
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Herbert B Slade, MD, Study chair, HealthpointNeeta Nayak, MD, Principal investigator, Golden Acres
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01108523
- Sponsor's protocol ID
- 828-101-09-017
- Status last verified
- Oct 2013
- First submitted
- 20 Apr 2010
- Last updated
- 6 Dec 2013
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 6 Dec 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Open Label Evaluation of the Effects of HP828-101 in the Management of Moisture Associated Skin Damage in Adults
- ClinicalTrials.gov ID
- NCT01108523
- Acronym / sponsor ID
- 828-101-09-017
- Conditions
- Skin Abnormalities
- Keywords
- Moisture Associated Skin Damage
- Phase
- Early Phase 1
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Business decision
- Enrolment
- 7 participants (actual)
- Lead sponsor
- HealthpointIndustry (pharma, biotech, devices)
- Study start
- Apr 2010
- Primary completion
- Jul 2010 (actual)
- Study completion
- Feb 2012 (actual)
- First posted
- 22 Apr 2010 (estimated)
- Results
- Posted 6 Dec 2013
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This study evaluates HP828 in the management of moisture associated skin damage after 15 days of use.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| HP828-101 | Experimental | Device: HP828-101HP828-101 Experimental Formulation |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (10 listed)
- - The informed consent document must be read, signed, and dated by the subject or the subject's legally authorized representative before conducting any study procedures or exams. In addition, the informed consent document must be signed and dated by the individual who consents the subject before conducting Visit 1. A photocopy of the signed informed consent document must be provided to the subject or subject representative, and the original signed document placed in the subject's chart. If the subject is unable to read or sign the informed consent, or unable to comprehend the information provided in the consent process, a legal guardian, decision making proxy, or next of kin must provide written consent, and if possible, subject must verbally assent to receiving an experimental treatment for their wound.
- Are 18 years of age or older, of either sex and of any race or skin type provided that their skin color, in the opinion of the Investigator, will not interfere with the study assessments.
- Are expected to remain in the Nursing Home or long-term acute-care (LTAC) for the duration of the study (15 days).
- Have moisture associated skin damage including denuded skin or ulceration, where:
- Are able to verbally respond to the Pre- and Post- Treatment Survey.
Key exclusion criteria (11 listed)
- Have more than 64 cm2 of denuded area.
- Have a full-thickness target wound, or a full-thickness wound within 4 cm of any target wound area.
- Have clinical evidence of bacterial or fungal infection of the target wound area.
- Have, within the area of moisture damaged skin, any tunneling, sinus tracks, shear injury, arterial occlusive disease, or bony prominence or joint with the exception that target wounds may be over dorsal spinous processes, coccyx, ischial tuberosities, or sacroiliac joints.
- Are moribund, or have a severe burn, debilitating immunodeficiency disorder, significant hematologic disorder, metastatic malignancy, uncontrolled diabetes mellitus, or any medical conditions that, in the opinion of the Investigator, places the subject at risk for the study or incapable of healing.
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 |
|---|---|---|
| HP828-101 | Device | HP828-101 |
Primary outcome
Rating Scores of Skin Erythema, Skin Pallor, Skin Maceration, Skin Denudation at Day 15.
Time frame: 15 Days
1 secondary outcome
Rating Scores of Skin Erythema, Skin Pallor, Skin Maceration, Skin Denudation at Day 4, 8, and 12. Proportion of Subjects With no Denuded Skin Area at Day 4, 8, 12, and 15. Pre- and Post-Treatment Surveys
Time frame: 4, 8, 12, and 15 days
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Dec 2013.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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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.
Herbert B Slade, MD study chair
Healthpoint
Neeta Nayak, MD principal investigator
Golden Acres
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Early Phase 1 study testing HP828-101 in people with Skin Abnormalities, 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 10 inclusion and 11 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: stopped early, as of the sponsor's last update on 6 Dec 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. 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?
Early Phase 1 (sometimes called Phase 0) studies give a very small amount of a treatment to a few people, mainly to see how the body handles it.
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 6 Dec 2013). 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?
Rating Scores of Skin Erythema, Skin Pallor, Skin Maceration, Skin Denudation at Day 15. (time frame: 15 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 6 Dec 2013.