Non-melanoma Skin CancerPhase 2NCT01359735
Healing Effects of HP802-247 Versus Antibiotic Ointment in Mohs Micrographic Surgery Patients
A Phase 2 study testing HP802-247 and Bacitracin Ointment in people with Non-melanoma Skin Cancer, run by Healthpoint at 1 site in United States.
Trial summary
This study compares HP802-247 versus an antibiotic ointment for healing the wound after Mohs surgery. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Non-melanoma Skin Cancer
- What is being tested?
- HP802-247 and Bacitracin Ointment
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 8 participants
- Where
- 1 siteUnited States
- Study dates
- May 2011to May 2012
- Phase
- Phase 2
- 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
- Provide informed consent.
- Age ≥ 18 years and of either sex.
- Type I, II, or III skin as assessed by the Fitzpatrick Scale.
- Willing to comply with protocol instructions, including allowing all study assessments.
- Scheduled to have head or neck non-melanoma skin cancers removed by Mohs micrographic surgery with final wound size of 8 mm to 20 mm in diameter or with 8 mm to 20 mm long axis if not circular.
- Acceptable state of health and nutrition, in the opinion of the Investigator.
Who cannot join
- History of anaphylaxis, serum sickness, or erythema multiforme reaction to aprotinin, bovine serum albumin or bovine serum proteins, penicillin, streptomycin, or amphotericin B.
- Therapy with blood-thinning agents including aspirin within 14 days of the Baseline Visit (these may be resumed post-surgery).
- Subjects with platelet or coagulation disorders.
- Therapy with another investigational agent within thirty (30) days of Screening, or during the study.
- Current systemic therapy with cytotoxic drugs.
- Current therapy with chronic (> 10 days) oral corticosteroids.
- In the opinion of the Investigator the subject has a current life expectancy of less than 1 year.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Phase II Randomized, Open-label Study Investigating the Healing Effects of HP802-247 Versus Antibiotic Ointment in Mohs Micrographic Surgery Patients
This study compares HP802-247 versus an antibiotic ointment for healing the wound after Mohs surgery.
- Conditions
- Non-melanoma Skin Cancer
- Being tested
- HP802-247, Bacitracin Ointment
- Keywords
- Wound, non-melanoma skin cancer, Mohs micrographic surgery, Head or neck
- Medical subject headings
- Wounds and Injuries
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
HP802-247Biological
High dose HP 802-247, applied at each visit (Week 1-13) or until healed
Bacitracin OintmentBiological
One dose of Bacitracin ointment consists of 50 units/1 gram. This will be applied daily for 12 weeks (or until healed).
| Study group | Role | What they receive |
|---|---|---|
| HP802-247 | Active comparator | allogeneic, growth arrested keratinocytes and fibroblasts: final concentration of 5.0 M cells/mL with a ratio of 1:9 keratinocytes:fibroblasts, applied weekly Receives: Biological: HP802-247 |
| Bacitracin Ointment | Active comparator | bacitracin antibiotic ointment Receives: Biological: Bacitracin Ointment |
What is being measured
The primary outcome is the main question the study is designed to answer.
The Primary Efficacy Measure Was the Investigator's Global Assessment of Healing (IGAH).
The IGAH is a four-point scale based on the following assessment scores: 0 = not effective, 1 = slightly effective, 2 = moderately effective, 3 = very effective. The descriptive statistics for both a continuous variable and a categorical variable were summarized for IGAH by treatment week and treatment endpoint. The Wilcoxon rank-sum test was used to test the difference in IGAH score between HP802-247 and bacitracin ointment for each treatment week and treatment endpoint. Since this was a small and exploratory study, the P-value of a 1-sided test was reported.
Measured: 13 weeks- The IGAH was measured at study Weeks 4 and 13
Secondary outcomes (4)
The Number of Subjects With Complete Wound Closure at Each Evaluation Visit.
Complete wound closure was assessed at each evaluation visit.
Measured: Over 12 weeks or until wound closure, which ever occurred first. Following completion of treatment subjects were followed for a further 4 weeks
Time in Days to Wound Closure
The Kaplan-Meier survival analysis was used to calculate the mean time in days to complete wound closure.
Measured: Over the 12 week treatment period
Investigator Reported Signs and Symptoms
Investigator reported signs and/or symptoms, based on the following 12 items, each scored as none (=0), mild (=1), moderate (=2), or severe (=3): Erythema, Erosion, Ulceration, Swelling, Scarring, Infection, Crusting, Necrosis, Peeling, Contact Dermatitis, Hyper/Hypopigmentation. Item scores were averaged.
Measured: At each evaluation visit: Weeks 3 and 12 post-surgery.
Subject Reported Signs and Symptoms
Subjects reported signs or symptoms, based on the following 6 items, each scored as none (=0), mild (=1), moderate (=2), or severe (=3): irritation, itchiness, burning, tenderness, pain, and stinging. Item scores were averaged.
Measured: At each evaluation visit: Weeks 3, and 12 post-surgery.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 May 2011 (estimated)
- Study startMay 2011
- Primary completionNov 2011
- Study completionMay 2012
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 Non-melanoma Skin CancerStudies 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 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 8 participants (actual)
Sponsor and investigators
- Lead sponsor
- Healthpoint
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Herbert B Slade, MD, Study chair, Healthpoint
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01359735
- Sponsor's protocol ID
- 802-247-09-022
- Status last verified
- May 2017
- First submitted
- 23 May 2011
- Last updated
- 29 Jun 2017
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 29 Jun 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase II Randomized, Open-label Study Investigating the Healing Effects of HP802-247 Versus Antibiotic Ointment in Mohs Micrographic Surgery Patients
- ClinicalTrials.gov ID
- NCT01359735
- Acronym / sponsor ID
- 802-247-09-022
- Conditions
- Non-melanoma Skin Cancer
- Keywords
- Wound, non-melanoma skin cancer, Mohs micrographic surgery, Head or neck
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 8 participants (actual)
- Lead sponsor
- HealthpointIndustry (pharma, biotech, devices)
- Study start
- May 2011
- Primary completion
- Nov 2011 (actual)
- Study completion
- May 2012 (actual)
- First posted
- 25 May 2011 (estimated)
- Results
- Posted 29 Jun 2017
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This study compares HP802-247 versus an antibiotic ointment for healing the wound after Mohs surgery.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| HP802-247 | Active comparator | Biological: HP802-247allogeneic, growth arrested keratinocytes and fibroblasts: final concentration of 5.0 M cells/mL with a ratio of 1:9 keratinocytes:fibroblasts, applied weekly |
| Bacitracin Ointment | Active comparator | Biological: Bacitracin Ointmentbacitracin antibiotic ointment |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Provide informed consent.
- Age ≥ 18 years and of either sex.
- Type I, II, or III skin as assessed by the Fitzpatrick Scale.
- Willing to comply with protocol instructions, including allowing all study assessments.
- Scheduled to have head or neck non-melanoma skin cancers removed by Mohs micrographic surgery with final wound size of 8 mm to 20 mm in diameter or with 8 mm to 20 mm long axis if not circular.
Key exclusion criteria (7 listed)
- History of anaphylaxis, serum sickness, or erythema multiforme reaction to aprotinin, bovine serum albumin or bovine serum proteins, penicillin, streptomycin, or amphotericin B.
- Therapy with blood-thinning agents including aspirin within 14 days of the Baseline Visit (these may be resumed post-surgery).
- Subjects with platelet or coagulation disorders.
- Therapy with another investigational agent within thirty (30) days of Screening, or during the study.
- Current systemic therapy with cytotoxic drugs.
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 |
|---|---|---|
| HP802-247High dose HP 802-247, applied at each visit (Week 1-13) or until healed | Biological | HP802-247 |
| Bacitracin OintmentOne dose of Bacitracin ointment consists of 50 units/1 gram. This will be applied daily for 12 weeks (or until healed). | Biological | Bacitracin Ointment |
Primary outcome
The Primary Efficacy Measure Was the Investigator's Global Assessment of Healing (IGAH).
Time frame: 13 weeks- The IGAH was measured at study Weeks 4 and 13
The IGAH is a four-point scale based on the following assessment scores: 0 = not effective, 1 = slightly effective, 2 = moderately effective, 3 = very effective. The descriptive statistics for both a continuous variable and a categorical variable were summarized for IGAH by treatment week and treatment endpoint. The Wilcoxon rank-sum test was used to test the difference in IGAH score between HP802-247 and bacitracin ointment for each treatment week and treatment endpoint. Since this was a small and exploratory study, the P-value of a 1-sided test was reported.
4 secondary outcomes
The Number of Subjects With Complete Wound Closure at Each Evaluation Visit.
Time frame: Over 12 weeks or until wound closure, which ever occurred first. Following completion of treatment subjects were followed for a further 4 weeks
Time in Days to Wound Closure
Time frame: Over the 12 week treatment period
Investigator Reported Signs and Symptoms
Time frame: At each evaluation visit: Weeks 3 and 12 post-surgery.
Subject Reported Signs and Symptoms
Time frame: At each evaluation visit: Weeks 3, and 12 post-surgery.
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Jun 2017.
- 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
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing HP802-247 and Bacitracin Ointment in people with Non-melanoma Skin Cancer, 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 6 inclusion and 7 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 29 Jun 2017. 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 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
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 29 Jun 2017). 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?
The Primary Efficacy Measure Was the Investigator's Global Assessment of Healing (IGAH). (time frame: 13 weeks- The IGAH was measured at study Weeks 4 and 13). 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 29 Jun 2017.