Healing Effects of HP802-247 Versus Antibiotic Ointment in Mohs Micrographic Surgery Patients
|ClinicalTrials.gov Identifier: NCT01359735|
Recruitment Status : Completed
First Posted : May 25, 2011
Results First Posted : June 29, 2017
Last Update Posted : June 29, 2017
|Condition or disease||Intervention/treatment||Phase|
|Non-melanoma Skin Cancer||Biological: HP802-247 Biological: Bacitracin Ointment||Phase 2|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||8 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|Official Title:||A Phase II Randomized, Open-label Study Investigating the Healing Effects of HP802-247 Versus Antibiotic Ointment in Mohs Micrographic Surgery Patients|
|Study Start Date :||May 2011|
|Actual Primary Completion Date :||November 2011|
|Actual Study Completion Date :||May 2012|
Active Comparator: 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
High dose HP 802-247, applied at each visit (Week 1-13) or until healed
Active Comparator: Bacitracin Ointment
bacitracin antibiotic ointment
Biological: 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). [ 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.
- 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 ]Complete wound closure was assessed at each evaluation visit.
- Time in Days to Wound Closure [ Time Frame: Over the 12 week treatment period ]The Kaplan-Meier survival analysis was used to calculate the mean time in days to complete wound closure.
- Investigator Reported Signs and Symptoms [ Time Frame: 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.
- Subject Reported Signs and Symptoms [ Time Frame: 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.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01359735
|United States, Kentucky|
|Derm Research PLC|
|Louisville, Kentucky, United States, 40217|
|Study Chair:||Herbert B Slade, MD||Healthpoint|