Healing Ointment Usage Post-surgical Procedure

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

Status

Completed

Phases

Phase 4

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT05686928

Acronym

Cetaphil

Enrollment

Registered

2023-01-17

Start date

2022-08-17

Completion date

2022-11-30

Last updated

2025-05-22

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Surgical Wound

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.

Interventions

DRUGCetaphil Healing Ointment

Topical ointment application twice daily

Study design

Allocation

Intervention model

SINGLE_GROUP

Primary purpose

SUPPORTIVE_CARE

Masking

NONE

Intervention model description

Multi-center, open-label study

Eligibility

Sex/Gender

ALL

Age

18 Years to 85 Years

Healthy volunteers

Yes

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

Design outcomes

Primary

Measure	Time frame	Description
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).
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).

Secondary

Measure	Time frame	Description
Subject Satisfaction Using a Self-assessment Questionnaire	Day 7/14	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.

Countries

United States

Participant flow

Pre-assignment details

15 subjects met the inclusion and exclusion criteria, and were enrolled in the study.

Participants by arm

Arm	Count
Healing Ointment Petrolatum-based opaque ointment applied to surgical wound twice daily. Cetaphil Healing Ointment: Topical ointment application twice daily	15
Total	15

Baseline characteristics

Characteristic	Healing Ointment
Age, Continuous	56.3 years STANDARD_DEVIATION 21.85
Race/Ethnicity, Customized Race/Ethnicity Caucasian Non-Hispanic	10 Participants
Race/Ethnicity, Customized Race/Ethnicity Hispanic	5 Participants
Region of Enrollment United States	15 participants
Sex: Female, Male Female	8 Participants
Sex: Female, Male Male	7 Participants

Adverse events

Event type	EG000 affected / at risk
deaths Total, all-cause mortality	0 / 15
other Total, other adverse events	0 / 15
serious Total, serious adverse events	0 / 15

Outcome results

Primary

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