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Completed

NCT Number: NCT05686928

Healing Ointment Usage Post-surgical Procedure

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

Completed

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Key information

Conditions

Surgical Wound Wounds and Injuries

Age range

18 year–85 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Derm Texas, Dallas, Texas, United States

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About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Cetaphil Healing Ointment

Drug

Topical ointment application twice daily

Primary outcomes

  1. 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).

  2. 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).

  3. 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).

  4. 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).

  5. 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).

  6. 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).

  7. 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).

Secondary outcomes

  1. Subject Satisfaction Using a Self-assessment Questionnaire

    Time frame: 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.

  2. Subject Satisfaction Using a Self-assessment Questionnaire

    Time frame: 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.

Sponsors and collaborators

Lead sponsor

Galderma R&D

Industry

Registry information

Official study title

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

Acronym: Cetaphil

Important dates

Study start
2022
Primary completion
2022
Study completion
2022
First posted
Jan 17, 2023
Registry last updated
May 22, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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