Surgical WoundPhase 4CetaphilNCT05686928

Healing Ointment Usage Post-surgical Procedure

A Phase 4 study testing Cetaphil Healing Ointment in people with Surgical Wound, run by Galderma R&D at 2 sites in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial summary

To evaluate benefits of a Healing Ointment in skin improvement after dermatologic procedures Read more about this study

Who is it for?: Ages 18 to 85 yearsHealthy volunteers can take part
Conditions the study is for: Surgical Wound
What is being tested?: Cetaphil Healing Ointment
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 15 participants
Where: 2 sitesUnited States
Study dates: 17 Aug 2022to 30 Nov 2022
Phase: Phase 4
Are there results?: Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 18 to 85 years
All sexes
Healthy volunteers accepted
Adult, Older adult

Who may be able to join

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

Who cannot join

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

Trial locations and contacts

2 sites in 1 country.

United States2 sites

Derm Texas
Dallas, Texas, 75235
Legacy Dermatology
Frisco, Texas, 75034

Other trials in United States

About this study

Official title: 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

Read the 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.

Conditions: Surgical Wound
Being tested: Cetaphil Healing Ointment
Medical subject headings: Surgical Wound

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Cetaphil Healing OintmentDrug
Topical ointment application twice daily

Study groups in NCT05686928
Study group	Role	What they receive
Healing Ointment	Experimental	Petrolatum-based opaque ointment applied to surgical wound twice daily. Receives: Drug: Cetaphil Healing Ointment

What is being measured

The primary outcome is the main question the study is designed to answer.

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

Secondary outcomes (2)

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.
Measured: 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.
Measured: Day 28

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

17 Aug 202230 Nov 2022

First posted17 Jan 2023
Study start17 Aug 2022
Primary completion31 Oct 2022
Study completion30 Nov 2022

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Other trials for Surgical WoundStudies of the same condition, open and under way.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase 4
Primary purpose: Supportive care
Allocation: Not applicable
Intervention model: Single group
Model description: Multi-center, open-label study
Masking: None (open label)
Enrolment: 15 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT05686928
Sponsor's protocol ID: GLI.04.US.SL.017
Acronym: Cetaphil
Status last verified: May 2025
First submitted: 7 Nov 2022
Last updated: 22 May 2025
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No
FDA-regulated drug: Yes
FDA-regulated device: No
Individual data sharing: No

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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Study at a glance

From the registry record, last updated by the sponsor on 22 May 2025. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: A Multi-center, Prospective Pilot Study on Safety and Effectiveness of a Healing Ointment as a Post-surgical Care
ClinicalTrials.gov ID: NCT05686928
Acronym / sponsor ID: Cetaphil / GLI.04.US.SL.017
Conditions: Surgical Wound
Phase: Phase 4
Study type: Interventional
Recruitment status: Completed
Enrolment: 15 participants (actual)
Lead sponsor: Galderma R&DIndustry (pharma, biotech, devices)
Study start: 17 Aug 2022 (actual)
Primary completion: 31 Oct 2022 (actual)
Study completion: 30 Nov 2022 (actual)
First posted: 17 Jan 2023 (actual)
Results: Posted 22 May 2025

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

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

Detailed description

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.

Study design

Primary purpose: Supportive care
Allocation: Not applicable
Intervention model: Single group
Masking: None (open label)
Number of arms: 1
Model description: Multi-center, open-label study

Arm	Type	Receives
Healing Ointment	Experimental	Drug: Cetaphil Healing OintmentPetrolatum-based opaque ointment applied to surgical wound twice daily.

Who may qualify

Ages: 18 to 85 years
Sex: All
Healthy volunteers: Accepted
Age groups: Adult, Older adult

Key inclusion criteria (3 listed)

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

Key exclusion criteria (6 listed)

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

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
Cetaphil Healing OintmentTopical ointment application twice daily	Drug	Healing Ointment

Primary outcome

Objective Erythema Assessment Using Clinical Grading Analog Scale
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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).

2 secondary outcomes

Subject Satisfaction Using a Self-assessment Questionnaire
Time frame: Day 7/14
Subject Satisfaction Using a Self-assessment Questionnaire
Time frame: Day 28

Results and safety

Results posted to the registry on 22 May 2025, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Healing Ointment	15	12

Primary outcome: Objective Erythema Assessment Using Clinical Grading Analog Scale

Time frame: Immediately post-procedure (on the same day of the procedure), day 7/14, and day 28 from baseline. Mean (Standard Deviation). Unit: score on a scale

Measure	Healing Ointment n = 15
Baseline	0.8 (0.68)
Immediate post-procedure	0.83 (0.65)
Day 7/14	0.75 (0.64)
Day 28	0.29 (0.45)

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

Primary outcome: Objective Edema Assessment Using Clinical Grading Analog Scale

Time frame: Immediately post-procedure (on the same day of the procedure), day 7/14, and day 28 from baseline. Mean (Standard Deviation). Unit: score on a scale

Measure	Healing Ointment n = 15
Baseline	0.03 (0.13)
Immediate post-procedure	0.5 (0.5)
Day 7/14	0 (0)
Day 28	0 (0)

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

Primary outcome: Objective Overall Wound Appearance Assessment Using Clinical Grading Analog Scale

Time frame: Immediately post-procedure (on the same day of the procedure), day 7/14, and day 28 from baseline. Mean (Standard Deviation). Unit: score on a scale

Measure	Healing Ointment n = 15
Baseline	0.57 (0.88)
Immediate post-procedure	2.13 (0.48)
Day 7/14	1.36 (0.46)
Day 28	0.54 (0.66)

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

Primary outcome: Objective Scabbing/Crusting Assessment Using Clinical Grading Analog Scale

Time frame: Immediately post-procedure (on the same day of the procedure), day 7/14, and day 28 from baseline. Mean (Standard Deviation). Unit: score on a scale

Measure	Healing Ointment n = 15
Baseline	0.53 (0.83)
Immediate post-procedure	0 (0)
Day 7/14	0.14 (0.31)
Day 28	0 (0)

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

2 secondary outcomes are reported in the full results.

Adverse events

Time frame: 4 weeks (i.e., from the study start to the study completion).. Other adverse events reported at 0% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Healing Ointment	0 of 15 (0%)	0 of 15 (0%)	0 of 15

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 22 May 2025.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Individual participant dataSharing planned: No

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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Aaron Farberg, MD principal investigator

Derm Texas and Legacy Dermatology

2 sites in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A Phase 4 study testing Cetaphil Healing Ointment in people with Surgical Wound, run by Galderma R&D at 2 sites in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 3 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 22 May 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 2 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 22 May 2025). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Objective Erythema Assessment Using Clinical Grading Analog Scale (time frame: Immediately post-procedure (on the same day of the procedure), day 7/14, and day 28 from baseline). The study lists 7 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05686928.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 May 2025.