Healing Ointment Usage Post-surgical Procedure

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE4

Total Enrollment

15 participants

Study Classification

INTERVENTIONAL

Study Start Date

2022-08-17

Study Completion Date

2022-11-30

Brief Summary

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

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Detailed Description

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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.

Conditions

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Surgical Wound

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Multi-center, open-label study

Primary Study Purpose

SUPPORTIVE_CARE

Blinding Strategy

NONE

Study Groups

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Healing Ointment

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

Group Type EXPERIMENTAL

Cetaphil Healing Ointment

Intervention Type DRUG

Topical ointment application twice daily

Interventions

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Cetaphil Healing Ointment

Topical ointment application twice daily

Intervention Type DRUG

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Maximum Eligible Age

85 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes