Healing Ointment Usage Post-surgical Procedure

NCT05686928 | Completed Phase 4 Results FDA Drug

• 1 other identifier: GLI.04.US.SL.017
• Study Type: interventional
• Target: 15
• Locations: 1 country
• Sites: 2

Brief Summary

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

Conditions

Surgical Wound

Outcome Measures

Primary Outcomes (7)

• 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).

  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).

  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).

  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).

  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).

  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).

  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).

  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

  Day 7/14

• Subject Satisfaction Using a Self-assessment Questionnaire

  Day 28

Study Arms (1)

Healing Ointment

EXPERIMENTAL

Petrolatum-based opaque ointment applied to surgical wound twice daily.

Drug: Cetaphil Healing Ointment

Interventions

Cetaphil Healing Ointment DRUG

Topical ointment application twice daily

Healing Ointment

Eligibility Criteria

• Age: 18 Years - 85 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Galderma R&D: lead

Study Sites (2)

Derm Texas

Dallas, Texas, 75235, United States

Location

Legacy Dermatology

Frisco, Texas, 75034, United States

Location

MeSH Terms

Conditions

Surgical Wound

Condition Hierarchy (Ancestors)

Wounds and Injuries

Results Point of Contact

• Title: Thu Q. Nguyen, PhD
• Organization: Galderma

thu.nguyen@galderma.com

8179615495

Study Officials

• Aaron Farberg, MD

  Derm Texas and Legacy Dermatology

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: NA
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: Multi-center, open-label study

Study Record Dates

• First Submitted: November 7, 2022
• First Posted: January 17, 2023
• Study Start: August 17, 2022
• Primary Completion: October 31, 2022
• Study Completion: November 30, 2022
• Last Updated: May 22, 2025
• Results First Posted: May 22, 2025

Record last verified: 2025-05

Data Sharing

• IPD Sharing: Will not share

Locations

US (2)