Trial Outcomes & Findings for Healing Effects of HP802-247 Versus Antibiotic Ointment in Mohs Micrographic Surgery Patients (NCT NCT01359735)

Last Updated: 2017-06-29

Results Overview

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.

Recruitment status

COMPLETED

Study phase

PHASE2

Target enrollment

8 participants

Primary outcome timeframe

13 weeks- The IGAH was measured at study Weeks 4 and 13

Results posted on

2017-06-29

Participant Flow

Subjects were enrolled at a single US investigational site, between June 22, 2011and November 16, 2011

Subjects who met inclusion criteria returned for visit1 on the day of surgery and entered the study following. Subjects randomly assigned to HP802-247 or Bacitracin for post-surgical treatment, which lasted for up to 12 weeks or wound closure, which ever occurred first. Following completion of treatment subjects were followed for 4 weeks

Participant milestones

Participant milestones
Measure	HP802-247 allogeneic, growth arrested keratinocytes and fibroblasts: final concentration of 5.0 M cells/mL with a ratio of 1:9 keratinocytes:fibroblasts, applied weekly HP802-247: High dose HP 802-247, applied at each visit (Week 1-13) or until healed	Bacitracin Ointment bacitracin antibiotic ointment Bacitracin Ointment: One dose of Bacitracin ointment consists of 50 units/1 gram. This will be applied daily for 12 weeks (or until healed).
Overall Study STARTED	4	4
Overall Study COMPLETED	4	4
Overall Study NOT COMPLETED	0	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Healing Effects of HP802-247 Versus Antibiotic Ointment in Mohs Micrographic Surgery Patients

Baseline characteristics by cohort

PRIMARY outcome

Timeframe: 13 weeks- The IGAH was measured at study Weeks 4 and 13

Population: The ITT population - all subjects who underwent MMS.

Outcome measures

Outcome measures
Measure	HP802-247 n=4 Participants allogeneic, growth arrested keratinocytes and fibroblasts: final concentration of 5.0 M cells/mL with a ratio of 1:9 keratinocytes:fibroblasts, applied weekly HP802-247: High dose HP 802-247, applied at each visit (Week 1-13) or until healed	Bacitracin Ointment n=4 Participants bacitracin antibiotic ointment Bacitracin Ointment: 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). Week 04	2.75 units on a scale Standard Deviation 0.5	2.25 units on a scale Standard Deviation 0.96
The Primary Efficacy Measure Was the Investigator's Global Assessment of Healing (IGAH). Week 13	3.00 units on a scale Standard Deviation 0	3.00 units on a scale Standard Deviation 0

SECONDARY outcome

Timeframe: Over 12 weeks or until wound closure, which ever occurred first. Following completion of treatment subjects were followed for a further 4 weeks

Population: 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.

Complete wound closure was assessed at each evaluation visit.

Outcome measures

Outcome measures
Measure	HP802-247 n=4 Participants allogeneic, growth arrested keratinocytes and fibroblasts: final concentration of 5.0 M cells/mL with a ratio of 1:9 keratinocytes:fibroblasts, applied weekly HP802-247: High dose HP 802-247, applied at each visit (Week 1-13) or until healed	Bacitracin Ointment n=4 Participants bacitracin antibiotic ointment Bacitracin Ointment: One dose of Bacitracin ointment consists of 50 units/1 gram. This will be applied daily for 12 weeks (or until healed).
The Number of Subjects With Complete Wound Closure at Each Evaluation Visit. Week 01	0 participants	0 participants
The Number of Subjects With Complete Wound Closure at Each Evaluation Visit. Week 02	0 participants	0 participants
The Number of Subjects With Complete Wound Closure at Each Evaluation Visit. Week 03	0 participants	0 participants
The Number of Subjects With Complete Wound Closure at Each Evaluation Visit. Week 04	3 participants	2 participants
The Number of Subjects With Complete Wound Closure at Each Evaluation Visit. Week 13	4 participants	4 participants
The Number of Subjects With Complete Wound Closure at Each Evaluation Visit. Week 17/Exit	4 participants	4 participants

SECONDARY outcome

Timeframe: Over the 12 week treatment period

Population: The ITT population - all subjects who underwent MMS. The Log-rank test was used to test for an inter-group difference.

The Kaplan-Meier survival analysis was used to calculate the mean time in days to complete wound closure.

Outcome measures

Outcome measures
Measure	HP802-247 n=4 Participants allogeneic, growth arrested keratinocytes and fibroblasts: final concentration of 5.0 M cells/mL with a ratio of 1:9 keratinocytes:fibroblasts, applied weekly HP802-247: High dose HP 802-247, applied at each visit (Week 1-13) or until healed	Bacitracin Ointment n=4 Participants bacitracin antibiotic ointment Bacitracin Ointment: One dose of Bacitracin ointment consists of 50 units/1 gram. This will be applied daily for 12 weeks (or until healed).
Time in Days to Wound Closure	24.8 Days Standard Deviation 2.1	28.0 Days Standard Deviation 3.5

SECONDARY outcome

Timeframe: At each evaluation visit: Weeks 3 and 12 post-surgery.

Population: 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.

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.

Outcome measures

Outcome measures
Measure	HP802-247 n=4 Participants allogeneic, growth arrested keratinocytes and fibroblasts: final concentration of 5.0 M cells/mL with a ratio of 1:9 keratinocytes:fibroblasts, applied weekly HP802-247: High dose HP 802-247, applied at each visit (Week 1-13) or until healed	Bacitracin Ointment n=4 Participants bacitracin antibiotic ointment Bacitracin Ointment: One dose of Bacitracin ointment consists of 50 units/1 gram. This will be applied daily for 12 weeks (or until healed).
Investigator Reported Signs and Symptoms 3 Weeks Post Surgery	1.75 units on a scale Standard Deviation 0.96	3 units on a scale Standard Deviation 1.83
Investigator Reported Signs and Symptoms 12 Weeks Post Surgery	1.00 units on a scale Standard Deviation 0.82	1.00 units on a scale Standard Deviation 0.82

SECONDARY outcome

Timeframe: At each evaluation visit: Weeks 3, and 12 post-surgery.

Population: 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.

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.

Outcome measures

Outcome measures
Measure	HP802-247 n=4 Participants allogeneic, growth arrested keratinocytes and fibroblasts: final concentration of 5.0 M cells/mL with a ratio of 1:9 keratinocytes:fibroblasts, applied weekly HP802-247: High dose HP 802-247, applied at each visit (Week 1-13) or until healed	Bacitracin Ointment n=4 Participants bacitracin antibiotic ointment Bacitracin Ointment: One dose of Bacitracin ointment consists of 50 units/1 gram. This will be applied daily for 12 weeks (or until healed).
Subject Reported Signs and Symptoms Week 3 Post-surgery	0 units on a scale Standard Deviation 0	0.75 units on a scale Standard Deviation 0.96
Subject Reported Signs and Symptoms Week 12 Post-surgery	0.25 units on a scale Standard Deviation 0.50	0 units on a scale Standard Deviation 0

Adverse Events

HP802-247

Serious events: 0 serious events

Other events: 2 other events

Deaths: 0 deaths

Bacitracin Ointment

Serious events: 0 serious events

Other events: 3 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Other adverse events
Measure	HP802-247 n=4 participants at risk allogeneic, growth arrested keratinocytes and fibroblasts: final concentration of 5.0 M cells/mL with a ratio of 1:9 keratinocytes:fibroblasts, applied weekly HP802-247: High dose HP 802-247, applied at each visit (Week 1-13) or until healed	Bacitracin Ointment n=4 participants at risk bacitracin antibiotic ointment Bacitracin Ointment: One dose of Bacitracin ointment consists of 50 units/1 gram. This will be applied daily for 12 weeks (or until healed).
Infections and infestations Bronchitis	0.00% 0/4 • Safety reporting occurred over the eight weeks of the study. All subjects randomized to treatment were questioned about adverse events and were included in the number of participants assessed for safety. The first assessments at each visit were about changes in general health and concomitant medications and the occurrence of adverse events.	25.0% 1/4 • Number of events 1 • Safety reporting occurred over the eight weeks of the study. All subjects randomized to treatment were questioned about adverse events and were included in the number of participants assessed for safety. The first assessments at each visit were about changes in general health and concomitant medications and the occurrence of adverse events.
Injury, poisoning and procedural complications Arthropod sting	0.00% 0/4 • Safety reporting occurred over the eight weeks of the study. All subjects randomized to treatment were questioned about adverse events and were included in the number of participants assessed for safety. The first assessments at each visit were about changes in general health and concomitant medications and the occurrence of adverse events.	25.0% 1/4 • Number of events 1 • Safety reporting occurred over the eight weeks of the study. All subjects randomized to treatment were questioned about adverse events and were included in the number of participants assessed for safety. The first assessments at each visit were about changes in general health and concomitant medications and the occurrence of adverse events.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Basal cell carcinoma	0.00% 0/4 • Safety reporting occurred over the eight weeks of the study. All subjects randomized to treatment were questioned about adverse events and were included in the number of participants assessed for safety. The first assessments at each visit were about changes in general health and concomitant medications and the occurrence of adverse events.	25.0% 1/4 • Number of events 1 • Safety reporting occurred over the eight weeks of the study. All subjects randomized to treatment were questioned about adverse events and were included in the number of participants assessed for safety. The first assessments at each visit were about changes in general health and concomitant medications and the occurrence of adverse events.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Melanocytic naevus	25.0% 1/4 • Number of events 1 • Safety reporting occurred over the eight weeks of the study. All subjects randomized to treatment were questioned about adverse events and were included in the number of participants assessed for safety. The first assessments at each visit were about changes in general health and concomitant medications and the occurrence of adverse events.	0.00% 0/4 • Safety reporting occurred over the eight weeks of the study. All subjects randomized to treatment were questioned about adverse events and were included in the number of participants assessed for safety. The first assessments at each visit were about changes in general health and concomitant medications and the occurrence of adverse events.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Seborrhoeic keratosis	25.0% 1/4 • Number of events 1 • Safety reporting occurred over the eight weeks of the study. All subjects randomized to treatment were questioned about adverse events and were included in the number of participants assessed for safety. The first assessments at each visit were about changes in general health and concomitant medications and the occurrence of adverse events.	25.0% 1/4 • Number of events 1 • Safety reporting occurred over the eight weeks of the study. All subjects randomized to treatment were questioned about adverse events and were included in the number of participants assessed for safety. The first assessments at each visit were about changes in general health and concomitant medications and the occurrence of adverse events.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Squamous cell carcinoma	25.0% 1/4 • Number of events 1 • Safety reporting occurred over the eight weeks of the study. All subjects randomized to treatment were questioned about adverse events and were included in the number of participants assessed for safety. The first assessments at each visit were about changes in general health and concomitant medications and the occurrence of adverse events.	0.00% 0/4 • Safety reporting occurred over the eight weeks of the study. All subjects randomized to treatment were questioned about adverse events and were included in the number of participants assessed for safety. The first assessments at each visit were about changes in general health and concomitant medications and the occurrence of adverse events.
Nervous system disorders Headache	25.0% 1/4 • Number of events 1 • Safety reporting occurred over the eight weeks of the study. All subjects randomized to treatment were questioned about adverse events and were included in the number of participants assessed for safety. The first assessments at each visit were about changes in general health and concomitant medications and the occurrence of adverse events.	0.00% 0/4 • Safety reporting occurred over the eight weeks of the study. All subjects randomized to treatment were questioned about adverse events and were included in the number of participants assessed for safety. The first assessments at each visit were about changes in general health and concomitant medications and the occurrence of adverse events.
Vascular disorders Hypertension	25.0% 1/4 • Number of events 1 • Safety reporting occurred over the eight weeks of the study. All subjects randomized to treatment were questioned about adverse events and were included in the number of participants assessed for safety. The first assessments at each visit were about changes in general health and concomitant medications and the occurrence of adverse events.	0.00% 0/4 • Safety reporting occurred over the eight weeks of the study. All subjects randomized to treatment were questioned about adverse events and were included in the number of participants assessed for safety. The first assessments at each visit were about changes in general health and concomitant medications and the occurrence of adverse events.

Additional Information

Jaime E Dickerson, PhD

Smith & Nephew

Phone: 1-817-302-3914

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place

Restriction type: LTE60

Measure	HP802-247 n=4 Participants allogeneic, growth arrested keratinocytes and fibroblasts: final concentration of 5.0 M cells/mL with a ratio of 1:9 keratinocytes:fibroblasts, applied weekly HP802-247: High dose HP 802-247, applied at each visit (Week 1-13) or until healed	Bacitracin Ointment n=4 Participants bacitracin antibiotic ointment Bacitracin Ointment: One dose of Bacitracin ointment consists of 50 units/1 gram. This will be applied daily for 12 weeks (or until healed).	Total n=8 Participants Total of all reporting groups
Age, Continuous	74 years STANDARD_DEVIATION 11.6 • n=5 Participants	66.8 years STANDARD_DEVIATION 10.7 • n=7 Participants	70.4 years STANDARD_DEVIATION 11 • n=5 Participants
Age, Customized 50-69 yrs	2 participants n=5 Participants	2 participants n=7 Participants	4 participants n=5 Participants
Age, Customized 70+ yrs	2 participants n=5 Participants	2 participants n=7 Participants	4 participants n=5 Participants
Sex: Female, Male Female	1 Participants n=5 Participants	0 Participants n=7 Participants	1 Participants n=5 Participants
Sex: Female, Male Male	3 Participants n=5 Participants	4 Participants n=7 Participants	7 Participants n=5 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	4 Participants n=5 Participants	4 Participants n=7 Participants	8 Participants n=5 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Asian	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Black or African American	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) White	4 Participants n=5 Participants	4 Participants n=7 Participants	8 Participants n=5 Participants
Race (NIH/OMB) More than one race	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants