Clinical trial NCT05686928: Healing Ointment Usage Post-surgical Procedure
Official title: A Multi-center, Prospective Pilot Study on Safety and Effectiveness of a Healing Ointment as a Post-surgical Care
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Surgical Wound
Lead sponsor: Galderma R&D
Sponsor class: INDUSTRY
First posted: 2023-01-17
Enrollment: 15
Sex: ALL
Minimum age (years): 18
Maximum age (years): 85
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: Multi-center, open-label study
Primary purpose: SUPPORTIVE_CARE

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

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.

Eligibility criteria: 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

Primary outcomes:
measure: Objective Erythema Assessment Using Clinical Grading Analog Scale
timeFrame: Immediately post-procedure (on the same day of the procedure), day 7/14, and day 28 from baseline
measure: Objective Edema Assessment Using Clinical Grading Analog Scale
timeFrame: Immediately post-procedure (on the same day of the procedure), day 7/14, and day 28 from baseline
measure: Objective Overall Wound Appearance Assessment Using Clinical Grading Analog Scale
timeFrame: Immediately post-procedure (on the same day of the procedure), day 7/14, and day 28 from baseline
measure: Objective Scabbing/Crusting Assessment Using Clinical Grading Analog Scale
timeFrame: Immediately post-procedure (on the same day of the procedure), day 7/14, and day 28 from baseline
measure: Subjective Burning Assessment Using an Analog Scale
timeFrame: Immediately post-procedure (on the same day of the procedure), day 7/14, and day 28 from baseline
measure: Subjective Itching Assessment Using an Analog Scale
timeFrame: Immediately post-procedure (on the same day of the procedure), day 7/14, and day 28 from baseline
measure: Subjective Pain Assessment Using an Analog Scale
timeFrame: Immediately post-procedure (on the same day of the procedure), day 7/14, and day 28 from baseline
Secondary outcomes:
measure: Subject Satisfaction Using a Self-assessment Questionnaire
timeFrame: Day 7/14
measure: Subject Satisfaction Using a Self-assessment Questionnaire
timeFrame: Day 28
Other outcomes:
Locations:
city: Dallas
country: United States
facility: Derm Texas
state: Texas
city: Frisco
country: United States
facility: Legacy Dermatology
state: Texas
Study officials:
affiliation: Derm Texas and Legacy Dermatology
name: Aaron Farberg, MD
role: PRINCIPAL_INVESTIGATOR
References: