Trial Outcomes & Findings for Healing Ointment Usage Post-surgical Procedure (NCT NCT05686928)

NCT ID: NCT05686928

Last Updated: 2025-05-22

Results Overview

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).

• Recruitment status: COMPLETED
• Study phase: PHASE4
• Target enrollment: 15 participants
• Primary outcome timeframe: Immediately post-procedure (on the same day of the procedure), day 7/14, and day 28 from baseline
• Results posted on: 2025-05-22

Participant Flow

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

Participant milestones

Measure	Healing Ointment Petrolatum-based opaque ointment applied to surgical wound twice daily. Cetaphil Healing Ointment: Topical ointment application twice daily
Overall Study STARTED	15
Overall Study COMPLETED	12
Overall Study NOT COMPLETED	3

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Healing Ointment Usage Post-surgical Procedure

Baseline characteristics by cohort

Measure	Healing Ointment n=15 Participants Petrolatum-based opaque ointment applied to surgical wound twice daily. Cetaphil Healing Ointment: Topical ointment application twice daily
Age, Continuous	56.3 years STANDARD_DEVIATION 21.85 • n=93 Participants
Sex: Female, Male Female	8 Participants n=93 Participants
Sex: Female, Male Male	7 Participants n=93 Participants
Race/Ethnicity, Customized Race/Ethnicity · Caucasian Non-Hispanic	10 Participants n=93 Participants
Race/Ethnicity, Customized Race/Ethnicity · Hispanic	5 Participants n=93 Participants
Region of Enrollment United States	15 participants n=93 Participants

PRIMARY outcome

Timeframe: Immediately post-procedure (on the same day of the procedure), day 7/14, and day 28 from baseline

Population: Analysis population was based on Intent-to-Treat population.

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).

Outcome measures

Measure	Healing Ointment n=15 Participants Petrolatum-based opaque ointment applied to surgical wound twice daily. Cetaphil Healing Ointment: Topical ointment application twice daily
Objective Erythema Assessment Using Clinical Grading Analog Scale Baseline	0.8 score on a scale Standard Deviation 0.68
Objective Erythema Assessment Using Clinical Grading Analog Scale Immediate post-procedure	0.83 score on a scale Standard Deviation 0.65
Objective Erythema Assessment Using Clinical Grading Analog Scale Day 7/14	0.75 score on a scale Standard Deviation 0.64
Objective Erythema Assessment Using Clinical Grading Analog Scale Day 28	0.29 score on a scale Standard Deviation 0.45

PRIMARY outcome

Timeframe: Immediately post-procedure (on the same day of the procedure), day 7/14, and day 28 from baseline

Population: Analysis population was based on Intent-to-Treat population.

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).

Outcome measures

Measure	Healing Ointment n=15 Participants Petrolatum-based opaque ointment applied to surgical wound twice daily. Cetaphil Healing Ointment: Topical ointment application twice daily
Objective Edema Assessment Using Clinical Grading Analog Scale Baseline	0.03 score on a scale Standard Deviation 0.13
Objective Edema Assessment Using Clinical Grading Analog Scale Immediate post-procedure	0.5 score on a scale Standard Deviation 0.5
Objective Edema Assessment Using Clinical Grading Analog Scale Day 7/14	0 score on a scale Standard Deviation 0
Objective Edema Assessment Using Clinical Grading Analog Scale Day 28	0 score on a scale Standard Deviation 0

PRIMARY outcome

Timeframe: Immediately post-procedure (on the same day of the procedure), day 7/14, and day 28 from baseline

Population: Analysis population was based on Intent-to-Treat population.

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).

Outcome measures

Measure	Healing Ointment n=15 Participants Petrolatum-based opaque ointment applied to surgical wound twice daily. Cetaphil Healing Ointment: Topical ointment application twice daily
Objective Overall Wound Appearance Assessment Using Clinical Grading Analog Scale Baseline	0.57 score on a scale Standard Deviation 0.88
Objective Overall Wound Appearance Assessment Using Clinical Grading Analog Scale Immediate post-procedure	2.13 score on a scale Standard Deviation 0.48
Objective Overall Wound Appearance Assessment Using Clinical Grading Analog Scale Day 7/14	1.36 score on a scale Standard Deviation 0.46
Objective Overall Wound Appearance Assessment Using Clinical Grading Analog Scale Day 28	0.54 score on a scale Standard Deviation 0.66

PRIMARY outcome

Timeframe: Immediately post-procedure (on the same day of the procedure), day 7/14, and day 28 from baseline

Population: Analysis population was based on Intent-to-Treat population.

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).

Outcome measures

Measure	Healing Ointment n=15 Participants Petrolatum-based opaque ointment applied to surgical wound twice daily. Cetaphil Healing Ointment: Topical ointment application twice daily
Objective Scabbing/Crusting Assessment Using Clinical Grading Analog Scale Baseline	0.53 score on a scale Standard Deviation 0.83
Objective Scabbing/Crusting Assessment Using Clinical Grading Analog Scale Immediate post-procedure	0 score on a scale Standard Deviation 0
Objective Scabbing/Crusting Assessment Using Clinical Grading Analog Scale Day 7/14	0.14 score on a scale Standard Deviation 0.31
Objective Scabbing/Crusting Assessment Using Clinical Grading Analog Scale Day 28	0 score on a scale Standard Deviation 0

PRIMARY outcome

Timeframe: Immediately post-procedure (on the same day of the procedure), day 7/14, and day 28 from baseline

Population: Analysis population was based on Intent-to-Treat population.

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).

Outcome measures

Measure	Healing Ointment n=15 Participants Petrolatum-based opaque ointment applied to surgical wound twice daily. Cetaphil Healing Ointment: Topical ointment application twice daily
Subjective Burning Assessment Using an Analog Scale Baseline	0.2 score on a scale Standard Deviation 0.56
Subjective Burning Assessment Using an Analog Scale Immediate post-procedure	0 score on a scale Standard Deviation 0
Subjective Burning Assessment Using an Analog Scale Day 7/14	0.04 score on a scale Standard Deviation 0.13
Subjective Burning Assessment Using an Analog Scale Day 28	0 score on a scale Standard Deviation 0

PRIMARY outcome

Timeframe: Immediately post-procedure (on the same day of the procedure), day 7/14, and day 28 from baseline

Population: Analysis population was based on Intent-to-Treat population.

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).

Outcome measures

Measure	Healing Ointment n=15 Participants Petrolatum-based opaque ointment applied to surgical wound twice daily. Cetaphil Healing Ointment: Topical ointment application twice daily
Subjective Itching Assessment Using an Analog Scale Baseline	0.53 score on a scale Standard Deviation 0.74
Subjective Itching Assessment Using an Analog Scale Immediate post-procedure	0.07 score on a scale Standard Deviation 0.26
Subjective Itching Assessment Using an Analog Scale Day 7/14	0.04 score on a scale Standard Deviation 0.13
Subjective Itching Assessment Using an Analog Scale Day 28	0 score on a scale Standard Deviation 0

PRIMARY outcome

Timeframe: Immediately post-procedure (on the same day of the procedure), day 7/14, and day 28 from baseline

Population: Analysis population was based on Intent-to-Treat population.

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).

Outcome measures

Measure	Healing Ointment n=15 Participants Petrolatum-based opaque ointment applied to surgical wound twice daily. Cetaphil Healing Ointment: Topical ointment application twice daily
Subjective Pain Assessment Using an Analog Scale Baseline	0.13 score on a scale Standard Deviation 0.52
Subjective Pain Assessment Using an Analog Scale Immediate post-procedure	0 score on a scale Standard Deviation 0
Subjective Pain Assessment Using an Analog Scale Day 7/14	0 score on a scale Standard Deviation 0
Subjective Pain Assessment Using an Analog Scale Day 28	0 score on a scale Standard Deviation 0

SECONDARY outcome

Timeframe: 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.

Outcome measures

Measure	Healing Ointment n=14 Participants Petrolatum-based opaque ointment applied to surgical wound twice daily. Cetaphil Healing Ointment: Topical ointment application twice daily
Subject Satisfaction Using a Self-assessment Questionnaire Subjects reported the wound felt moisturized	13 Participants
Subject Satisfaction Using a Self-assessment Questionnaire Subjects reported the treatment product soothed the wound and surrounding skin	13 Participants
Subject Satisfaction Using a Self-assessment Questionnaire Subjects reported the treatment product improved the status of the wound	13 Participants
Subject Satisfaction Using a Self-assessment Questionnaire Subjects reported the treatment product did not irritate the wound area	14 Participants

SECONDARY outcome

Timeframe: 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.

Outcome measures

Measure	Healing Ointment n=12 Participants Petrolatum-based opaque ointment applied to surgical wound twice daily. Cetaphil Healing Ointment: Topical ointment application twice daily
Subject Satisfaction Using a Self-assessment Questionnaire Subjects reported the treatment product helped the wound heal effectively	12 Participants
Subject Satisfaction Using a Self-assessment Questionnaire Subjects reported the treatment product provided a protective layer for the wound	12 Participants
Subject Satisfaction Using a Self-assessment Questionnaire Subjects reported the treatment product kept the wound surface clean and moisturized	11 Participants
Subject Satisfaction Using a Self-assessment Questionnaire Subjects reported the treatment product did not feel greasy on their skin	10 Participants

Adverse Events

Healing Ointment

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Thu Q. Nguyen, PhD

Galderma

Phone: 8179615495

Email: thu.nguyen@galderma.com

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place