Healing Ointment Usage Post-surgical Procedure

Study Overview
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Brief Summary
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To evaluate benefits of a Healing Ointment in skin improvement after dermatologic procedures

Detailed Description
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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.

Official Title
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A Multi-center, Prospective Pilot Study on Safety and Effectiveness of a Healing Ointment as a Post-surgical Care

Conditions
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Surgical Wound

Intervention / Treatment
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* Drug: Cetaphil Healing Ointment


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Subject who undergo Mohs surgery, skin biopsy, excision on the head/neck or body Ability of giving consent for participation in the study Agreement to adhere to the procedures and requirements of the study and to report to the institute on the day(s) and at the time(s) scheduled for the assessments Exclusion Criteria: History of allergy or hypersensitivity to cosmetic ingredients Pregnant, planning pregnancy during the course of the study or breastfeeding Subject with a history of keloids or hypertrophic scars Presence of tattoo and/or scar in the treatment area that in the investigator's opinion would interfere with study assessments Subjects with history of or the presence of any skin condition/disease that might interfere with the diagnosis or evaluation of study parameters (i.e., atopic dermatitis, eczema, psoriasis, seborrheic dermatitis) at the discretion of the investigator Subjects with inability to comply with all study protocol restrictions and visits

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 85 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Supportive Care
Intervention Model: Single Group Assignment
Interventional Model Description: Multi-center, open-label study
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Healing Ointment<br>Petrolatum-based opaque ointment applied to surgical wound twice daily. | Drug: Cetaphil Healing Ointment<br>* Topical ointment application twice daily<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Objective tolerability 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. Assessment parameters include erythema, edema (0 = none, 1 = mild, 2 = moderate, 3 = severe), overall wound appearance (0 = excellent, 1 = good, 2 = fair, 3 = poor), and scabbing/crusting (0 = none, 1 = slight, 2 = moderate, 3 = extensive, 4 = almost complete/complete). | Immediately post-procedure (on the same day of the procedure), day 7/14, and day 28 from baseline | 
| Subjective tolerability 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. Assessment parameters include burning, itching, and pain (0 = none, 1 = mild, 2 = moderate, 3 = severe) | Immediately post-procedure (on the same day of the procedure), day 7/14, and day 28 from baseline | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | Day 7/14 and day 28 |