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To evaluate the efficacy of a tripeptide/hexapeptide topical (Alastin Regenerating Skin Nectar with TriHex Technology®) in wound healing and scar reduction following Erbium:YAG hybrid resurfacing laser for acne scarring compared to the standard of post-procedure care consisting of a bland moisturizer.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Experimental | Experimental |
| |
| Control | Placebo Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Hybrid fractional laser | Device | two treatments given one month apart |
|
| Measure | Description | Time Frame |
|---|---|---|
| Mean Change From Baseline in Erythema | A colorimeter will be used to measure the erythema index. The range of the index is 0-99 with 0 indicating better outcome. Erythema will be measured at baseline and at follow-up visits. The mean change from baseline will be averaged to get the overall mean for each arm at each follow up visit. | baseline to day 34 |
| Mean Change From Baseline in Erythema | A colorimeter will be used to measure the erythema index. The range of the index is 0-99 with 0 indicating better outcome. Erythema will be measured at baseline and at follow-up visits. The mean change from baseline will be averaged to get the overall mean for each arm at each follow up visit. | baseline to day 4 |
| Measure | Description | Time Frame |
|---|---|---|
| Mean Change in Skin Barrier Function | Barrier function will be measured by transepidermal water loss in grams/m2(hour). The lower the water loss the better the barrier function of the skin. Barrier function will be measured at baseline, days of laser treatment and 4 days after treatment. Laser treatment will occur at baseline and day 30. The mean change from baseline, at each follow-up visit, will be averaged to get the overall mean for each arm. |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Rochester Medical Center | Rochester | New York | 14642 | United States |
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| ID | Title | Description |
|---|---|---|
| FG000 | Experimental: Alastin Regenerating Skin Nectar With TriHex Technology | Hybrid fractional laser: two treatments given one month apart Alastin Regenerating Skin Nectar with TriHex Technology: applied twice daily |
| FG001 | Control: Cetaphil | Hybrid fractional laser: two treatments given one month apart Cetaphil face cream: applied twice daily |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Experimental: Alastin Regenerating Skin Nectar With TriHex Technology | Hybrid fractional laser: two treatments given one month apart Alastin Regenerating Skin Nectar with TriHex Technology: applied twice daily |
| BG001 | Control: Cetaphil |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| 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 | Mean Change From Baseline in Erythema | A colorimeter will be used to measure the erythema index. The range of the index is 0-99 with 0 indicating better outcome. Erythema will be measured at baseline and at follow-up visits. The mean change from baseline will be averaged to get the overall mean for each arm at each follow up visit. | One participant in the control group, discontinued prior to Day 30. | Posted | Mean | Standard Error | units on a scale | baseline to day 34 |
|
through study completion, approximately 90 days
Adverse event collection did not differ from the clinicaltrials.gov definition.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Experimental | Hybrid fractional laser: two treatments given one month apart Alastin Regenerating Skin Nectar with TriHex Technology: applied twice daily |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Melasma | Skin and subcutaneous tissue disorders | Non-systematic Assessment | Melasma, flare after first treatment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Mara Weinstein MD | University of Rochester Medical Center | (585) 275-7546 | Mara_Weinsteinvelez@URMC.Rochester.edu |
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| 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 | Jun 3, 2020 | Jun 17, 2022 | Prot_SAP_000.pdf |
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| ID | Term |
|---|---|
| D006984 | Hypertrophy |
| ID | Term |
|---|---|
| D020763 | Pathological Conditions, Anatomical |
| D013568 | Pathological Conditions, Signs and Symptoms |
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| Alastin Regenerating Skin Nectar with TriHex Technology | Other | applied twice daily |
|
| Cetaphil face cream | Other | applied twice daily |
|
| baseline to day 34 |
| Number of Participants Who Scored Skin Appearance as no Change, Improved or Much Improved Using the Global Aesthetic Improvement Scale | The Global Aesthetic Improvement Scale measures the appearance of the skin as reported by the participant. 1=worse; appearance has worsened compared with the original condition, 2=no change; appearance remains the same as the original condition, 3=improved; better than the initial condition, 4=much improved; marked improvement but not completely optimal, 5=very much improved; excellent or exceptional improvement. The number of participants within each grade will be reported. | baseline to day 90 |
Hybrid fractional laser: two treatments given one month apart Cetaphil face cream: applied twice daily |
| BG002 | Total | Total of all reporting groups |
| Participants |
|
| Age, Continuous | Mean | Full Range | years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race/Ethnicity, Customized | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
Hybrid fractional laser: two treatments given one month apart
Cetaphil face cream: applied twice daily
|
|
| Secondary | Mean Change in Skin Barrier Function | Barrier function will be measured by transepidermal water loss in grams/m2(hour). The lower the water loss the better the barrier function of the skin. Barrier function will be measured at baseline, days of laser treatment and 4 days after treatment. Laser treatment will occur at baseline and day 30. The mean change from baseline, at each follow-up visit, will be averaged to get the overall mean for each arm. | One participant in the control group discontinued prior to second laser treatment, Day 30. | Posted | Mean | Standard Error | g/m^2h | baseline to day 34 |
|
|
|
| Secondary | Number of Participants Who Scored Skin Appearance as no Change, Improved or Much Improved Using the Global Aesthetic Improvement Scale | The Global Aesthetic Improvement Scale measures the appearance of the skin as reported by the participant. 1=worse; appearance has worsened compared with the original condition, 2=no change; appearance remains the same as the original condition, 3=improved; better than the initial condition, 4=much improved; marked improvement but not completely optimal, 5=very much improved; excellent or exceptional improvement. The number of participants within each grade will be reported. | One participant in the control discontinued prior to Day 90. | Posted | Number | participants | baseline to day 90 |
|
|
|
| Primary | Mean Change From Baseline in Erythema | A colorimeter will be used to measure the erythema index. The range of the index is 0-99 with 0 indicating better outcome. Erythema will be measured at baseline and at follow-up visits. The mean change from baseline will be averaged to get the overall mean for each arm at each follow up visit. | One participant in the control group, discontinued prior to Day 30. | Posted | Mean | Standard Error | units on a scale | baseline to day 4 |
|
|
|
| 0 |
| 6 |
| 0 |
| 6 |
| 0 |
| 6 |
| EG001 | Control | Hybrid fractional laser: two treatments given one month apart Cetaphil face cream: applied twice daily | 0 | 4 | 0 | 4 | 1 | 4 |
|
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| Day 34 |
|
|
| Much Improved |
|