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| Name | Class |
|---|---|
| L'Oreal | INDUSTRY |
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Compare the effectiveness of laser treatment using CE Ferulic versus vehicle pre/post laser.
Evaluate the efficacy and tolerability of a Skinceuticals CE Ferulic® when used once daily over the course of 14 weeks with 2-week pre-treatment period and 12-week treatment period in pairing with two pre-elected laser treatments with 1927nm non-ablative fractional diode laser treatment for improving skin photoaging signs on the face.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Group A | Active Comparator | Subjects who will receive two treatments with 1927nm (Clear and Brilliant Perméa®) non-ablative fractional diode laser for rejuvenation of photodamaged skin of the face in pairing with Skinceuticals CE Ferulic |
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| Group B | Sham Comparator | Subjects who will receive two treatments with 1927nm (Clear and Brilliant Perméa®) non-ablative fractional diode laser for rejuvenation of photodamaged skin of the face in pairing with vehicle serum |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| CE Ferulic | Drug | CE Ferulic serum regimen combined with laser treatment |
| |
| Measure | Description | Time Frame |
|---|---|---|
| Global Fine Lines | Score 0 thru 9 Score 0= No fine lines present; skin looks completely smooth Score 9= Numerous, many fine lines densely packed together in the treatment area | Screening, Baseline, Day 28, Day 56, Day 84 |
| Overall Hyperpigmentation/ Discoloration | Score 0 thru 9 Score 0= No hyperpigmentation Score 9= Significant hyperpigmentation, numerous spots, uneven skin tone | Screening, Baseline, Day 28, Day 56, Day 84 |
| Skin Tone Evenness | Score 0 thru 9 Score 0= Very even tone Score 9= Uneven, discolored appearance (brown and/or red colors) | Screening, Baseline, Day 28, Day 56, Day 84 |
| Skin Elasticity | Score 0 thru 9 Score 0= Skin feels toned, dense Score 9= Skin feels pliable, thin and non-resilient | Screening, Baseline, Day 28, Day 56, Day 84 |
| Skin Firmness | Score 0 thru 9 Score 0= Firm, tight feeling skin Score 9= Loose, lax feeling skin | Screening, Baseline, Day 28, Day 56, Day 84 |
| Skin Radiance/ Brightness | Score 0 thru 9 Score 0= Very radiant, luminous or glowing appearance Score 9= Very dull/ matte and/or sallow skin appearance | Screening, Baseline, Day 28, Day 56, Day 84 |
| Skin Texture Smoothness | Score 0 thru 9 Score 0= Very smooth, even-looking skin texture, no roughness Score 9= Very rough, pronounced, extensive visible skin roughness |
| Measure | Description | Time Frame |
|---|---|---|
| Tolerability Assessment | Stinging/Burning: None No stinging/burning of the treatment area Mild Slight, but definite burning of the treatment area Moderate Definite stinging/burning of the treatment area Severe Marked stinging/burning of the treatment area Itching: None No itching of the treatment area Mild Slight, but definite itching of the treatment area Moderate Definite itching of the treatment area Severe Marked itching of the treatment area Rash: None No new rash over the treatment area Mild New rash covering some of the treatment area Moderate New rash covering much of the treatment area Severe New rash covering the entirety of the treatment area Tightness: None No tightness of the treatment area Mild Slight, but definite tightness of the treatment area Moderate Definite tightness of the treatment area Severe Marked tightness of the treatment area |
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Inclusion Criteria:
Exclusion Criteria:
malnutrition, steroid use, history of collagen vascular disease (e.g., lupus, scleroderma), atopic dermatitis, or immunologic abnormalities such as vitiligo.
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| West Dermatology Research Center | Contact | 858-657-1004 | research@clderm.com |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| West Dermatology Research Center | San Diego | California | 92121 | United States |
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Prospective, placebo-controlled, double-blinded, randomized study
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The blinded investigator will perform assessments at all study visits.
| Sham Comparator |
| Drug |
Vehicle serum regimen combined with laser treatment |
|
| 1927nm (Clear and Brilliant Perméa®) | Device | non-ablative fractional diode laser |
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| Screening, Baseline, Day 28, Day 56, Day 84 |
| Global Wrinkles | Score 0 thru 9 Score 0= No wrinkles present, no visible deep, wide and long wrinkles, skin looks smooth Score 9= Numerous wrinkles, deep, wide and long, densely packed together in the treatment area | Screening, Baseline, Day 28, Day 56, Day 84 |
| Baseline, Day 28 |
| Dermatology Quality of Life Index (Page 1) |
Very Much A lot A little Not at all | Screening, Baseline, Day 28, Day 56, Day 84 |
| Dermatology Quality of Life Index (Page 2) | 7.Over the last week, has your skin prevented you from working or studying: Yes or No 7a. If "no", over the last week how much has your skin been a problem at work or studying: Very Much A lot A little Not at all 8.Over the last week, how much has your skin created problems with your partner or any of your close friends or relatives: Very Much A lot A little Not at all 9.Over the last week, how much has your skin caused any sexual difficulties: Very Much A lot A little Not at all 10.Over the last week, how much of a problem has the treatment for your skin been, for example by making your home messy, or by taking up time: Very Much A lot A little Not at all | Screening, Baseline, Day 28, Day 56, Day 84 |
| Subject Self-Assessment Questionnaire (Page 1) |
Agree Strongly Agree Neither agree nor disagree Disagree Disagree Strongly | Screening, Baseline, Day 28, Day 56, Day 84 |
| Subject Self-Assessment Questionnaire (Page 2) | 8. With the product I'm more satisfied with the procedure results: Agree Strongly Agree Neither agree nor disagree Disagree Disagree Strongly 9. The product reduced the downtime of the procedure or makes the downtime more acceptable: Agree Strongly Agree Neither agree nor disagree Disagree Disagree Strongly 10. The product improves the outcome of the procedure: Agree Strongly Agree Neither agree nor disagree Disagree Disagree Strongly 11. With this product, I would feel more confident to do another procedure: Agree Strongly Agree Neither agree nor disagree Disagree Disagree Strongly 12. I would recommend this product post-procedure: Agree Strongly Agree Neither agree nor disagree Disagree Disagree Strongly | Screening, Baseline, Day 28, Day 56, Day 84 |
| Subject Self-Assessment Questionnaire (Page 3) | 13. It's the best post-procedure care I've ever used (if relevant) : Agree Strongly Agree Neither agree nor disagree Disagree Disagree Strongly 14. It is something I would use after future laser treatments: Agree Strongly Agree Neither agree nor disagree Disagree Disagree Strongly 15. The product has a pleasant texture: Agree Strongly Agree Neither agree nor disagree Disagree Disagree Strongly 16. The product absorbs quickly in to the skin: Agree Strongly Agree Neither agree nor disagree Disagree Disagree Strongly 17. It is a product I would recommend to others: Agree Strongly Agree Neither agree nor disagree Disagree Disagree Strongly | Screening, Baseline, Day 28, Day 56, Day 84 |