Healing Ointment Usage Post-surgical Procedure (Cetaphil)

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

To evaluate benefits of a Healing Ointment in skin improvement after dermatologic procedures

Study Overview

• Status: Completed
• Conditions: Surgical Wound
• Intervention / Treatment: Drug: Cetaphil Healing Ointment

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.

• Study Type: Interventional
• Enrollment (Actual): 15
• Phase: Phase 4

Contacts and Locations

Study Locations

• United States
  • Texas
    • Dallas, Texas, United States, 75235
      • Derm Texas
    • Frisco, Texas, United States, 75034
      • Legacy Dermatology

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 85 years (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Supportive Care
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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).	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).	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).	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).	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).	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).	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).	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
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 28

Collaborators and Investigators

• Sponsor: Galderma R&D
• Investigators: Principal Investigator: Aaron Farberg, MD, Derm Texas and Legacy Dermatology

Study record dates

Study Major Dates

• Study Start (Actual): August 17, 2022
• Primary Completion (Actual): October 31, 2022
• Study Completion (Actual): November 30, 2022

Study Registration Dates

• First Submitted: November 7, 2022
• First Submitted That Met QC Criteria: January 13, 2023
• First Posted (Actual): January 17, 2023

Study Record Updates

• Last Update Posted (Actual): May 22, 2025
• Last Update Submitted That Met QC Criteria: May 21, 2025
• Last Verified: May 1, 2025

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Wounds and Injuries; Surgical Wound
• Other Study ID Numbers: GLI.04.US.SL.017

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• 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