Cetaphil: Healing Ointment Usage Post-surgical Procedure

Sponsor

Galderma R&D (Industry)

Overall Status

Completed

CT.gov ID

NCT05686928

Collaborator

(none)

Enrollment

Locations

Arm

3.4

Actual Duration (Months)

7.5

Patients Per Site

2.2

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

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

Condition or Disease	Intervention/Treatment	Phase
Surgical Wound	Drug: Cetaphil Healing Ointment	Phase 4

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 Design

Study Type:

Interventional

Actual Enrollment :

15 participants

Allocation:

N/A

Intervention Model:

Single Group Assignment

Intervention Model Description:

Multi-center, open-label studyMulti-center, open-label study

Masking:

None (Open Label)

Primary Purpose:

Supportive Care

Official Title:

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

Actual Study Start Date :

Aug 17, 2022

Actual Primary Completion Date :

Oct 31, 2022

Actual Study Completion Date :

Nov 30, 2022

Arms and Interventions

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

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

Outcome Measures

Primary Outcome Measures

Objective tolerability 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. Assessment parameters include erythema, edema (0 = none, 1 = mild, 2 = moderate, 3 = severe), overall wound appearance (0 = excellent, 1 = good, 2 = fair, 3 = poor), and scabbing/crusting (0 = none, 1 = slight, 2 = moderate, 3 = extensive, 4 = almost complete/complete).
Subjective tolerability 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. Assessment parameters include burning, itching, and pain (0 = none, 1 = mild, 2 = moderate, 3 = severe)

Secondary Outcome Measures

Subject satisfaction using a self-assessment questionnaire [Day 7/14 and 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.

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 85 Years

Sexes Eligible for Study:

All

Accepts 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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Derm Texas	Dallas	Texas	United States	75235
2	Legacy Dermatology	Frisco	Texas	United States	75034

Sponsors and Collaborators

Galderma R&D

Investigators

Principal Investigator: Aaron Farberg, MD, Derm Texas and Legacy Dermatology

Study Documents (Full-Text)

Study Protocol and Statistical Analysis Plan - May 2, 2022

More Information

Publications

None provided.

Responsible Party:

Galderma R&D

ClinicalTrials.gov Identifier:

NCT05686928

Other Study ID Numbers:

GLI.04.US.SL.017

First Posted:

Jan 17, 2023

Last Update Posted:

Jan 17, 2023

Last Verified:

Oct 1, 2022

Individual Participant Data (IPD) Sharing Statement:

Plan to Share IPD:

Studies a U.S. FDA-regulated Drug Product:

Yes

Studies a U.S. FDA-regulated Device Product:

Product Manufactured in and Exported from the U.S.:

Yes

Additional relevant MeSH terms:

Surgical Wound

Study Results

No Results Posted as of Jan 17, 2023