Healing Ointment Usage Post-surgical Procedure

Surgical Wound Clinical Trial

— Cetaphil  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05686928
• Other study ID #: GLI.04.US.SL.017
• Status: Completed
• Phase: Phase 4
• Start date: August 17, 2022
• Est. completion date: November 30, 2022

Study information

• Verified date: October 2022
• Source: Galderma R&D
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

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 information / eligibility

• Status: Completed
• Enrollment: 15
• Est. completion date: November 30, 2022
• Est. primary completion date: October 31, 2022
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 85 Years

Eligibility

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

Related Conditions & MeSH terms

• Surgical Wound

Intervention

Drug:
• Cetaphil Healing Ointment
Topical ointment application twice daily

Locations

Country	Name	City	State
United States	Derm Texas	Dallas	Texas
United States	Legacy Dermatology	Frisco	Texas

Sponsors (1)

Lead Sponsor	Collaborator
Galderma R&D

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Objective tolerability 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. 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).	Immediately post-procedure (on the same day of the procedure), day 7/14, and day 28 from baseline
Primary	Subjective tolerability 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. Assessment parameters include burning, itching, and pain (0 = none, 1 = mild, 2 = moderate, 3 = severe)	Immediately post-procedure (on the same day of the procedure), day 7/14, and day 28 from baseline
Secondary	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.	Day 7/14 and day 28