A Phase 2 interventional study of HP802-247 and Bacitracin Ointment in Non-melanoma Skin Cancer, sponsored by Healthpoint. Completed at 1 site in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2017-06-29.
Sponsored by Healthpoint (part of Smith & Nephew, Inc.) · Phase 2, Interventional, and Treatment
This study compares HP802-247 versus an antibiotic ointment for healing the wound after Mohs surgery.
2,217 studies on the registry are indexed under Wounds and Injuries; 441 are open to participants now.
This study's enrollment of 8 is below the median of 70 across 1,424 interventional studies indexed under Wounds and Injuries.
Browse Wounds and Injuries studies →Healthpoint is the lead sponsor of 34 studies on the registry; none are open to participants now.
First submitted before Healthpoint became part of Smith & Nephew, Inc..
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Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
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Blood cells that help blood clot. Too few raises the risk of bleeding and bruising. A usual adult range is about 150–400 × 10⁹/L (150,000–400,000 per µL); each lab has its own reference range.
A drug or device being studied in a clinical trial.
It may be new, or already approved and being studied for another use, dose or form. Criteria often leave out people who took part in another study of one within a recent period, commonly 30 days or five half-lives.
Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.
Studies differ in what they allow: check which steroid medicines, routes (tablets, injections, creams, inhalers, eye drops) and doses this study accepts.
The study doctor’s estimate of how long someone is likely to live. Criteria use it so that people can stay in the study long enough for it to answer its question.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Platelets
Blood cells that help blood clot. Too few raises the risk of bleeding and bruising. A usual adult range is about 150–400 × 10⁹/L (150,000–400,000 per µL); each lab has its own reference range.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Investigational drug or device
A drug or device being studied in a clinical trial.
It may be new, or already approved and being studied for another use, dose or form. Criteria often leave out people who took part in another study of one within a recent period, commonly 30 days or five half-lives.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Corticosteroids (steroids)
Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.
Studies differ in what they allow: check which steroid medicines, routes (tablets, injections, creams, inhalers, eye drops) and doses this study accepts.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Life expectancy
The study doctor’s estimate of how long someone is likely to live. Criteria use it so that people can stay in the study long enough for it to answer its question.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
allogeneic, growth arrested keratinocytes and fibroblasts: final concentration of 5.0 M cells/mL with a ratio of 1:9 keratinocytes:fibroblasts, applied weekly
Biological: HP802-247
bacitracin antibiotic ointment
Biological: Bacitracin Ointment
High dose HP 802-247, applied at each visit (Week 1-13) or until healed
One dose of Bacitracin ointment consists of 50 units/1 gram. This will be applied daily for 12 weeks (or until healed).
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.
Time frame: 13 weeks- The IGAH was measured at study Weeks 4 and 13
The Number of Subjects With Complete Wound Closure at Each Evaluation Visit.
Complete wound closure was assessed 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
The Kaplan-Meier survival analysis was used to calculate the mean time in days to complete wound closure.
Time frame: 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.
Time frame: 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.
Time frame: At each evaluation visit: Weeks 3, and 12 post-surgery.
Subjects were enrolled at a single US investigational site, between June 22, 2011and November 16, 2011
| Milestone | HP802-247 | Bacitracin Ointment |
|---|---|---|
| Started | 4 | 4 |
| Completed | 4 | 4 |
| Not completed | 0 | 0 |
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.
| units on a scale | HP802-247 | Bacitracin Ointment |
|---|---|---|
| Week 04 | 2.75 ± 0.5 | 2.25 ± 0.96 |
| Week 13 | 3.00 ± 0 | 3.00 ± 0 |
Complete wound closure was assessed at each evaluation visit.
| participants | HP802-247 | Bacitracin Ointment |
|---|---|---|
| Week 01 | 0 | 0 |
| Week 02 | 0 | 0 |
| Week 03 | 0 | 0 |
| Week 04 | 3 | 2 |
| Week 13 | 4 | 4 |
| Week 17/Exit | 4 | 4 |
The Kaplan-Meier survival analysis was used to calculate the mean time in days to complete wound closure.
| Days | HP802-247 | Bacitracin Ointment |
|---|---|---|
| Time in Days to Wound Closure | 24.8 ± 2.1 | 28.0 ± 3.5 |
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.
| units on a scale | HP802-247 | Bacitracin Ointment |
|---|---|---|
| 3 Weeks Post Surgery | 1.75 ± 0.96 | 3 ± 1.83 |
| 12 Weeks Post Surgery | 1.00 ± 0.82 | 1.00 ± 0.82 |
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.
| units on a scale | HP802-247 | Bacitracin Ointment |
|---|---|---|
| Week 3 Post-surgery | 0 ± 0 | 0.75 ± 0.96 |
| Week 12 Post-surgery | 0.25 ± 0.50 | 0 ± 0 |
Collected over Safety reporting occurred over the eight weeks of the study.. Non-serious events are listed at a 0% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| HP802-247 | — | 0/4 (0%) | 2/4 (50%) |
| Bacitracin Ointment | — | 0/4 (0%) | 3/4 (75%) |
| Event | HP802-247 | Bacitracin Ointment |
|---|---|---|
| BronchitisInfections and infestations | 0/4 | 1/4 |
| Arthropod stingInjury, poisoning and procedural complications | 0/4 | 1/4 |
| Basal cell carcinomaNeoplasms benign, malignant and unspecified (incl cysts and polyps) | 0/4 | 1/4 |
| Melanocytic naevusNeoplasms benign, malignant and unspecified (incl cysts and polyps) | 1/4 | 0/4 |
| Seborrhoeic keratosisNeoplasms benign, malignant and unspecified (incl cysts and polyps) | 1/4 | 1/4 |
| Squamous cell carcinomaNeoplasms benign, malignant and unspecified (incl cysts and polyps) | 1/4 | 0/4 |
| HeadacheNervous system disorders | 1/4 | 0/4 |
| HypertensionVascular disorders | 1/4 | 0/4 |
| Age, Continuous(years) | HP802-247 | Bacitracin Ointment | Total |
|---|---|---|---|
| Mean | 74 ± 11.6 | 66.8 ± 10.7 | 70.4 ± 11 |
| Age, Customized(participants) | HP802-247 | Bacitracin Ointment | Total |
|---|---|---|---|
| 50-69 yrs | 2 | 2 | 4 |
| 70+ yrs | 2 | 2 | 4 |
| Sex: Female, Male(Participants) | HP802-247 | Bacitracin Ointment | Total |
|---|---|---|---|
| Female | 1 | 0 | 1 |
| Male | 3 | 4 | 7 |
| Ethnicity (NIH/OMB)(Participants) | HP802-247 | Bacitracin Ointment | Total |
|---|---|---|---|
| Hispanic or Latino | 0 | 0 | 0 |
| Not Hispanic or Latino | 4 | 4 | 8 |
| Unknown or Not Reported | 0 | 0 | 0 |
| Race (NIH/OMB)(Participants) | HP802-247 | Bacitracin Ointment | Total |
|---|---|---|---|
| American Indian or Alaska Native | 0 | 0 | 0 |
| Asian | 0 | 0 | 0 |
| Native Hawaiian or Other Pacific Islander | 0 | 0 | 0 |
| Black or African American | 0 | 0 | 0 |
| White | 4 | 4 | 8 |
| More than one race | 0 | 0 | 0 |
| Unknown or Not Reported | 0 | 0 | 0 |
This study is completed, as verified in May 2017. You cannot join it, but the record below documents what was studied.
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Studies of the drugs tested here: Topical Wound Spray HP802-247 · Bacitracin