Healing Ointment Usage Post-surgical Procedure

Phase 4

Completed

Conditions: Surgical Wound

Interventions: Drug: Cetaphil Healing Ointment

Registration Number: NCT05686928

Lead Sponsor: Galderma R&D

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.

Recruitment & Eligibility

Status: COMPLETED

Sex: All

Target Recruitment: 15

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 & Design

Study Type: INTERVENTIONAL

Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Healing Ointment	Cetaphil Healing Ointment	Petrolatum-based opaque ointment applied to surgical wound twice daily.

Primary Outcome Measures

Name	Time	Method
Subjective Itching Assessment Using an Analog Scale	Immediately post-procedure (on the same day of the procedure), day 7/14, and day 28 from baseline	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).
Subjective Pain Assessment Using an Analog Scale	Immediately post-procedure (on the same day of the procedure), day 7/14, and day 28 from baseline	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).
Objective Erythema Assessment Using Clinical Grading Analog Scale	Immediately post-procedure (on the same day of the procedure), day 7/14, and day 28 from baseline	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).
Objective Edema Assessment Using Clinical Grading Analog Scale	Immediately post-procedure (on the same day of the procedure), day 7/14, and day 28 from baseline	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).
Objective Overall Wound Appearance Assessment Using Clinical Grading Analog Scale	Immediately post-procedure (on the same day of the procedure), day 7/14, and day 28 from baseline	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).
Objective Scabbing/Crusting Assessment Using Clinical Grading Analog Scale	Immediately post-procedure (on the same day of the procedure), day 7/14, and day 28 from baseline	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).
Subjective Burning Assessment Using an Analog Scale	Immediately post-procedure (on the same day of the procedure), day 7/14, and day 28 from baseline	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).

Secondary Outcome Measures

Name	Time	Method
Subject Satisfaction Using a Self-assessment Questionnaire	Day 28	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.