Back to resultsHealing Ointment Usage Post-surgical Procedure (Cetaphil)
Primary Purpose
Surgical Wound
Status
Completed
Phase
Phase 4
Locations
United States
Study Type
Interventional
Intervention
Cetaphil Healing Ointment
Sponsored by
About this trial
This is an interventional supportive care trial for Surgical Wound
Eligibility Criteria
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
Sites / Locations
- Derm Texas
- Legacy Dermatology
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Healing Ointment
Arm Description
Petrolatum-based opaque ointment applied to surgical wound twice daily.
Outcomes
Primary Outcome Measures
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).
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)
Secondary Outcome Measures
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.
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT05686928
Brief Title
Healing Ointment Usage Post-surgical Procedure
Acronym
Cetaphil
Official Title
A Multi-center, Prospective Pilot Study on Safety and Effectiveness of a Healing Ointment as a Post-surgical Care
Study Type
Interventional
2. Study Status
Record Verification Date
October 2022
Overall Recruitment Status
Completed
Study Start Date
August 17, 2022 (Actual)
Primary Completion Date
October 31, 2022 (Actual)
Study Completion Date
November 30, 2022 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Galderma R&D
4. Oversight
Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Product Manufactured in and Exported from the U.S.
Yes
Data Monitoring Committee
No
5. Study Description
Brief Summary
To evaluate benefits of a Healing Ointment in skin improvement after dermatologic procedures
Detailed Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Surgical Wound
7. Study Design
Primary Purpose
Supportive Care
Study Phase
Phase 4
Interventional Study Model
Single Group Assignment
Model Description
Multi-center, open-label study
Masking
None (Open Label)
Allocation
N/A
Enrollment
15 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Healing Ointment
Arm Type
Experimental
Arm Description
Petrolatum-based opaque ointment applied to surgical wound twice daily.
Intervention Type
Drug
Intervention Name(s)
Cetaphil Healing Ointment
Intervention Description
Topical ointment application twice daily
Primary Outcome Measure Information:
Title
Objective tolerability assessment using clinical grading analog scale
Description
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).
Time Frame
Immediately post-procedure (on the same day of the procedure), day 7/14, and day 28 from baseline
Title
Subjective tolerability assessment using an analog scale
Description
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)
Time Frame
Immediately post-procedure (on the same day of the procedure), day 7/14, and day 28 from baseline
Secondary Outcome Measure Information:
Title
Subject satisfaction using a self-assessment questionnaire
Description
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 and day 28
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
85 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Aaron Farberg, MD
Organizational Affiliation
Derm Texas and Legacy Dermatology
Official's Role
Principal Investigator
Facility Information:
Facility Name
Derm Texas
City
Dallas
State/Province
Texas
ZIP/Postal Code
75235
Country
United States
Facility Name
Legacy Dermatology
City
Frisco
State/Province
Texas
ZIP/Postal Code
75034
Country
United States
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
Healing Ointment Usage Post-surgical Procedure
We'll reach out to this number within 24 hrs