Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
To evaluate benefits of a Healing Ointment in skin improvement after dermatologic procedures
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.
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Healing Ointment | Experimental | Petrolatum-based opaque ointment applied to surgical wound twice daily. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Cetaphil Healing Ointment | Drug | Topical ointment application twice daily |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| Subject Satisfaction Using a Self-assessment Questionnaire | 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. |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Aaron Farberg, MD | Derm Texas and Legacy Dermatology | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Derm Texas | Dallas | Texas | 75235 | United States | ||
| Legacy Dermatology |
Not provided
Not provided
Not provided
Not provided
Not provided
15 subjects met the inclusion and exclusion criteria, and were enrolled in the study.
Not provided
Not provided
| ID | Title | Description |
|---|---|---|
| FG000 | Healing Ointment | Petrolatum-based opaque ointment applied to surgical wound twice daily. Cetaphil Healing Ointment: Topical ointment application twice daily |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
Not provided
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | Healing Ointment | Petrolatum-based opaque ointment applied to surgical wound twice daily. Cetaphil Healing Ointment: Topical ointment application twice daily |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | 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). | Analysis population was based on Intent-to-Treat population. | Posted | Mean | Standard Deviation | score on a scale | Immediately post-procedure (on the same day of the procedure), day 7/14, and day 28 from baseline |
|
4 weeks (i.e., from the study start to the study completion).
Throughout the course of the study, all adverse events were monitored and reported on an adverse event CRF/eCRF without omitting any requested and known information.
Not provided
| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Healing Ointment | Petrolatum-based opaque ointment applied to surgical wound twice daily. Cetaphil Healing Ointment: Topical ointment application twice daily |
Not provided
Not provided
Not provided
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Thu Q. Nguyen, PhD | Galderma | 8179615495 | thu.nguyen@galderma.com |
Not provided
| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | May 2, 2022 | Nov 2, 2022 | Prot_SAP_000.pdf |
Not provided
Not provided
Not provided
| ID | Term |
|---|---|
| D000072836 | Surgical Wound |
| ID | Term |
|---|---|
| D014947 | Wounds and Injuries |
Not provided
Not provided
Multi-center, open-label study
Not provided
Not provided
Not provided
Not provided
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 |
| Day 7/14 |
| Subject Satisfaction Using a Self-assessment Questionnaire | 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. | Day 28 |
| Frisco |
| Texas |
| 75034 |
| United States |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race/Ethnicity, Customized | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
| Units | Counts |
|---|---|
| Participants |
|
|
| Primary | 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). | Analysis population was based on Intent-to-Treat population. | Posted | Mean | Standard Deviation | score on a scale | Immediately post-procedure (on the same day of the procedure), day 7/14, and day 28 from baseline |
|
|
|
| Primary | 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). | Analysis population was based on Intent-to-Treat population. | Posted | Mean | Standard Deviation | score on a scale | Immediately post-procedure (on the same day of the procedure), day 7/14, and day 28 from baseline |
|
|
|
| Primary | 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). | Analysis population was based on Intent-to-Treat population. | Posted | Mean | Standard Deviation | score on a scale | Immediately post-procedure (on the same day of the procedure), day 7/14, and day 28 from baseline |
|
|
|
| Primary | 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). | Analysis population was based on Intent-to-Treat population. | Posted | Mean | Standard Deviation | score on a scale | Immediately post-procedure (on the same day of the procedure), day 7/14, and day 28 from baseline |
|
|
|
| Primary | 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). | Analysis population was based on Intent-to-Treat population. | Posted | Mean | Standard Deviation | score on a scale | Immediately post-procedure (on the same day of the procedure), day 7/14, and day 28 from baseline |
|
|
|
| Primary | 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). | Analysis population was based on Intent-to-Treat population. | Posted | Mean | Standard Deviation | score on a scale | Immediately post-procedure (on the same day of the procedure), day 7/14, and day 28 from baseline |
|
|
|
| Secondary | Subject Satisfaction Using a Self-assessment Questionnaire | 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. | Posted | Count of Participants | Participants | Day 7/14 |
|
|
|
| Secondary | Subject Satisfaction Using a Self-assessment Questionnaire | 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. | Posted | Count of Participants | Participants | Day 28 |
|
|
|
| 0 |
| 15 |
| 0 |
| 15 |
| 0 |
| 15 |
Not provided
Not provided
|
| Day 7/14 |
|
|
| Day 28 |
|
|
|
| Day 7/14 |
|
|
| Day 28 |
|
|
|
| Day 7/14 |
|
|
| Day 28 |
|
|
|
| Day 7/14 |
|
|
| Day 28 |
|
|
|
| Day 7/14 |
|
|
| Day 28 |
|
|
|
| Day 7/14 |
|
|
| Day 28 |
|
|
|
| Subjects reported the treatment product did not irritate the wound area |
|
|
| Subjects reported the treatment product did not feel greasy on their skin |
|