Trial · NCT01359735
Healing Effects of HP802-247 Versus Antibiotic Ointment in Mohs Micrographic Surgery Patients
NCT01359735, Phase 2, Completed, Healthpoint; results first posted 2017-06-29
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. Healing Effects of HP802-247 Versus Antibiotic Ointment in Mohs Micrographic Surgery Patients. Trials, record NCT01359735. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT01359735
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Healing Effects of HP802-247 Versus Antibiotic Ointment in Mohs Micrographic Surgery Patients
- NCT number
- NCT01359735
- Status
- Completed
- Phases
- Phase 2
- Enrollment
- 8 participants, actual
- Lead sponsor
- Healthpoint
- Conditions
- Non-melanoma Skin Cancer
- Interventions
- HP802-247, Bacitracin Ointment
- First posted
- 2011-05-25
- Last updated
- 2017-06-29
- Results first posted
- 2017-06-29
Source ClinicalTrials.gov
Registered outcomes5
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | The Primary Efficacy Measure Was the Investigator's Global Assessment of Healing (IGAH). | 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. |
| Secondary | The Number of Subjects With Complete Wound Closure at Each Evaluation Visit. | Over 12 weeks or until wound closure, which ever occurred first. Following completion of treatment subjects were followed for a further 4 weeks | Complete wound closure was assessed at each evaluation visit. |
| Secondary | Time in Days to Wound Closure | Over the 12 week treatment period | The Kaplan-Meier survival analysis was used to calculate the mean time in days to complete wound closure. |
| Secondary | Investigator Reported Signs and Symptoms | At each evaluation visit: Weeks 3 and 12 post-surgery. | 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. |
| Secondary | Subject Reported Signs and Symptoms | At each evaluation visit: Weeks 3, and 12 post-surgery. | 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. |
Source ClinicalTrials.gov
Outcomes5
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | The Primary Efficacy Measure Was the Investigator's Global Assessment of Healing (IGAH). | 13 weeks- The IGAH was measured at study Weeks 4 and 13 | The ITT population - all subjects who underwent MMS. | units on a scale | MEAN |
| SECONDARY | The Number of Subjects With Complete Wound Closure at Each Evaluation Visit. | Over 12 weeks or until wound closure, which ever occurred first. Following completion of treatment subjects were followed for a further 4 weeks | The ITT population - all subjects who underwent MMS. Fisher's exact test was used to examine the difference in proportion of subjects with complete wound closure at each of the corresponding time points between the two treatment groups, and the P-value of a 1-sided test was reported. | participants | NUMBER |
| SECONDARY | Time in Days to Wound Closure | Over the 12 week treatment period | The ITT population - all subjects who underwent MMS. The Log-rank test was used to test for an inter-group difference. | Days | MEAN |
| SECONDARY | Investigator Reported Signs and Symptoms | At each evaluation visit: Weeks 3 and 12 post-surgery. | The ITT population-all subjects who underwent MMS. Both total score and individual item score of the two signs and symptoms rating scales summarized descriptively at Weeks 4, 7, and 13 as well as at the treatment endpoint and compared using a two-sample t-test. the P-value of a 1-sided test was reported. | units on a scale | MEAN |
| SECONDARY | Subject Reported Signs and Symptoms | At each evaluation visit: Weeks 3, and 12 post-surgery. | The ITT population - all subjects who underwent MMS. Both the total score and individual item score of the two signs and symptoms rating scales were summarized descriptively at Weeks 4, 7, and 13 as well as at the treatment endpoint and compared using a two-sample t-test, and the P-value of a 1-sided test was reported. | units on a scale | MEAN |
Source ClinicalTrials.gov
Results by group26
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| The Primary Efficacy Measure Was the Investigator's Global Assessment of Healing (IGAH). | HP802-247 | Week 04 | 2.75 | Standard Deviation 0.5 | units on a scale |
| The Primary Efficacy Measure Was the Investigator's Global Assessment of Healing (IGAH). | Bacitracin Ointment | Week 04 | 2.25 | Standard Deviation 0.96 | units on a scale |
| The Primary Efficacy Measure Was the Investigator's Global Assessment of Healing (IGAH). | HP802-247 | Week 13 | 3.00 | Standard Deviation 0 | units on a scale |
| The Primary Efficacy Measure Was the Investigator's Global Assessment of Healing (IGAH). | Bacitracin Ointment | Week 13 | 3.00 | Standard Deviation 0 | units on a scale |
| The Number of Subjects With Complete Wound Closure at Each Evaluation Visit. | HP802-247 | Week 01 | 0 | participants | |
| The Number of Subjects With Complete Wound Closure at Each Evaluation Visit. | Bacitracin Ointment | Week 01 | 0 | participants | |
| The Number of Subjects With Complete Wound Closure at Each Evaluation Visit. | HP802-247 | Week 02 | 0 | participants | |
| The Number of Subjects With Complete Wound Closure at Each Evaluation Visit. | Bacitracin Ointment | Week 02 | 0 | participants | |
| The Number of Subjects With Complete Wound Closure at Each Evaluation Visit. | HP802-247 | Week 03 | 0 | participants | |
| The Number of Subjects With Complete Wound Closure at Each Evaluation Visit. | Bacitracin Ointment | Week 03 | 0 | participants |
1 to 10 of 26Source ClinicalTrials.gov
See all 26 results by groupParticipant flow6
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | HP802-247 | 4 | |
| Overall Study | STARTED | Bacitracin Ointment | 4 | |
| Overall Study | COMPLETED | HP802-247 | 4 | |
| Overall Study | COMPLETED | Bacitracin Ointment | 4 | |
| Overall Study | NOT COMPLETED | HP802-247 | 0 | |
| Overall Study | NOT COMPLETED | Bacitracin Ointment | 0 |
Source ClinicalTrials.gov
Adverse events16
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
| Type | Event | Organ system | Group | Affected | At risk | Events |
|---|---|---|---|---|---|---|
| other | Bronchitis | Infections and infestations | HP802-247 | 0 | 4 | 0 |
| other | Bronchitis | Infections and infestations | Bacitracin Ointment | 1 | 4 | 1 |
| other | Arthropod sting | Injury, poisoning and procedural complications | HP802-247 | 0 | 4 | 0 |
| other | Arthropod sting | Injury, poisoning and procedural complications | Bacitracin Ointment | 1 | 4 | 1 |
| other | Basal cell carcinoma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | HP802-247 | 0 | 4 | 0 |
| other | Basal cell carcinoma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | Bacitracin Ointment | 1 | 4 | 1 |
| other | Melanocytic naevus | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | HP802-247 | 1 | 4 | 1 |
| other | Melanocytic naevus | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | Bacitracin Ointment | 0 | 4 | 0 |
| other | Seborrhoeic keratosis | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | HP802-247 | 1 | 4 | 1 |
| other | Seborrhoeic keratosis | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | Bacitracin Ointment | 1 | 4 | 1 |
1 to 10 of 16Source ClinicalTrials.gov
See all 16 adverse eventsAdverse event totals6
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | HP802-247 | ||
| Total, all-cause mortality | Bacitracin Ointment | ||
| Total, other adverse events | HP802-247 | 2 | 4 |
| Total, other adverse events | Bacitracin Ointment | 3 | 4 |
| Total, serious adverse events | HP802-247 | 0 | 4 |
| Total, serious adverse events | Bacitracin Ointment | 0 | 4 |
Source ClinicalTrials.gov
Papers0
The papers the trial lists on ClinicalTrials.gov.
None in this release.
Grants0
The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.
None in this release.
Trial comparisons1
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
| Comparison |
|---|
| HP802-247 vs Bacitracin Ointment: serious adverse events |
Source Trial comparisons
Tests0
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
None in this release.
Data dates
The day each source was copied for this release.
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
- NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
- ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
- ClinicalTrials.govnone stated
- NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
For software
Read this trial from software.
The record and each of its lists are JSON, twenty rows a page. No key.
GET https://conductscience.org/api/trials/v1/NCT01359735
GET https://conductscience.org/api/trials/v1/NCT01359735/results?page=2