To evaluate benefits of a Healing Ointment in skin improvement after dermatologic procedures
This is an open-label, multi-center study to evaluate the safety and efficacy of a Healing Ointment in skin improvement after dermatologic procedures such as Mohs surgery, skin biopsy, excision on the head/neck or body. The study is designed to enroll approximately 20 subjects, in which 10 subjects undergo dermatologic procedure on the head/neck and 10 subjects on the body. Eligible subjects apply the test product twice daily after the procedure, followed by efficacy and tolerability assessments, standard photography, and self-assessment questionnaire at each follow-up visit.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
SUPPORTIVE_CARE
Masking
NONE
Enrollment
15
Topical ointment application twice daily
Derm Texas
Dallas, Texas, United States
Legacy Dermatology
Frisco, Texas, United States
Objective Erythema Assessment Using Clinical Grading Analog Scale
Summary of change in tolerability from baseline to day 28, at the surgical area after using the Healing Ointment daily. Lower scores reflect a better outcome. Erythema assessment was graded clinically based on a scale from 0 to 3 (0 = none, 1 = mild, 2 = moderate, 3 = severe).
Time frame: Immediately post-procedure (on the same day of the procedure), day 7/14, and day 28 from baseline
Objective Edema Assessment Using Clinical Grading Analog Scale
Summary of change in tolerability from baseline to day 28, at the surgical area after using the Healing Ointment daily. Lower scores reflect a better outcome. Edema assessment was graded clinically based on a scale from 0 to 3 (0 = none, 1 = mild, 2 = moderate, 3 = severe).
Time frame: Immediately post-procedure (on the same day of the procedure), day 7/14, and day 28 from baseline
Objective Overall Wound Appearance Assessment Using Clinical Grading Analog Scale
Summary of change in tolerability from baseline to day 28, at the surgical area after using the Healing Ointment daily. Lower scores reflect a better outcome. Overall wound appearance was graded clinically based on a scale from 0 to 3 (0 = excellent, 1 = good, 2 = fair, 3 = poor).
Time frame: Immediately post-procedure (on the same day of the procedure), day 7/14, and day 28 from baseline
Objective Scabbing/Crusting Assessment Using Clinical Grading Analog Scale
Summary of change in tolerability from baseline to day 28, at the surgical area after using the Healing Ointment daily. Lower scores reflect a better outcome. Scabbing/crusting assessment was graded based on a scale from 0 to 4 (0 = none, 1 = slight, 2 = moderate, 3 = extensive, 4 = almost complete/complete).
Time frame: Immediately post-procedure (on the same day of the procedure), day 7/14, and day 28 from baseline
Subjective Burning Assessment Using an Analog Scale
Summary of change in tolerability from baseline to day 28, at the surgical area after using the Healing Ointment daily. Lower scores reflect a better outcome. Burning assessment was graded by subjects based on a scale from 0 to 3 (0 = none, 1 = mild, 2 = moderate, 3 = severe).
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Time frame: Immediately post-procedure (on the same day of the procedure), day 7/14, and day 28 from baseline
Subjective Itching Assessment Using an Analog Scale
Summary of change in tolerability from baseline to day 28, at the surgical area after using the Healing Ointment daily. Lower scores reflect a better outcome. Itching assessment was graded by subjects based on a scale from 0 to 3 (0 = none, 1 = mild, 2 = moderate, 3 = severe).
Time frame: Immediately post-procedure (on the same day of the procedure), day 7/14, and day 28 from baseline
Subjective Pain Assessment Using an Analog Scale
Summary of change in tolerability from baseline to day 28, at the surgical area after using the Healing Ointment daily. Lower scores reflect a better outcome. Pain assessment was graded by subjects based on a scale from 0 to 3 (0 = none, 1 = mild, 2 = moderate, 3 = severe).
Time frame: Immediately post-procedure (on the same day of the procedure), day 7/14, and day 28 from baseline
Subject Satisfaction Using a Self-assessment Questionnaire
Subjects are asked about their satisfaction with the treatment product and overall improvement at the treated area. Scale consists of 5 questions at every follow-up visit and subjects select level of satisfaction for each question from/to strongly agree, agree, neither, disagree, and strongly disagree. Upon study completion, subjects also provide their perception on recommendation, purchase intent, preference, and testimonial.
Time frame: Day 7/14
Subject Satisfaction Using a Self-assessment Questionnaire
Subjects are asked about their satisfaction with the treatment product and overall improvement at the treated area. Scale consists of 5 questions at every follow-up visit and subjects select level of satisfaction for each question from/to strongly agree, agree, neither, disagree, and strongly disagree. Upon study completion, subjects also provide their perception on recommendation, purchase intent, preference, and testimonial.
Time frame: Day 28