A Multi-center, Prospective Pilot Study on Safety and Effectiveness of a Healing Ointment as a Post-surgical Care
Trial Snapshot
- Phase
- Phase 4
- Status
- Completed
- Sponsor
- Galderma R&D
- Enrollment
- 15
- Locations
- 2
- Primary Endpoint
- Objective Erythema Assessment Using Clinical Grading Analog Scale
Study Overview
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.
Study Design
- Study Type
- Interventional
- Allocation
- Na
- Intervention Model
- Single Group
- Primary Purpose
- Supportive Care
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to 85 Years (Adult, Older Adult)
- Sex
- 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
Arms & Interventions
Healing Ointment
Petrolatum-based opaque ointment applied to surgical wound twice daily.
Intervention: Cetaphil Healing Ointment (Drug)
Outcomes
Primary Outcomes
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).
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).
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).
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).
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).
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).
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
- Subject Satisfaction Using a Self-assessment Questionnaire(Day 28)