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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
SUPPORTIVE_CARE
Masking
SINGLE
Enrollment
40
CE Ferulic serum regimen combined with laser treatment
Vehicle serum regimen combined with laser treatment
non-ablative fractional diode laser
West Dermatology Research Center
San Diego, California, United States
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
Time frame: 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
Time frame: 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)
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: Screening, Baseline, Day 28, Day 56, Day 84
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.
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
Time frame: Screening, Baseline, Day 28, Day 56, Day 84
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
Time frame: Baseline, Day 28
Dermatology Quality of Life Index (Page 1)
1. Over the last week, how itchy, sore, painful or stinging has your skin been: Very Much A lot A little Not at all 2. Over the last week, how embarrassed or self-conscious have you been because of your skin: Very Much A lot A little Not at all 3. Over the last week, how much has your skin interfered with you going shopping or looking after your home or garden: Very Much A lot A little Not at all 4. Over the last week, how much has your skin influenced the clothes you wear: Very Much A lot A little Not at all 5. Over the last week, how itchy, sore, painful or stinging has your skin been: Very Much A lot A little Not at all 6. Over the last week, how much has your skin made it difficult for you to do any sport: Very Much A lot A little Not at all
Time frame: 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
Time frame: Screening, Baseline, Day 28, Day 56, Day 84
Subject Self-Assessment Questionnaire (Page 1)
1. Skin feels more comfortable: Agree Strongly Agree Neither agree nor disagree Disagree Disagree Strongly 2. Skin appears younger looking: Agree Strongly Agree Neither agree nor disagree Disagree Disagree Strongly 3. Skin appears healthier: Agree Strongly Agree Neither agree nor disagree Disagree Disagree Strongly 4. Skin looks renewed/ revitalized: Agree Strongly Agree Neither agree nor disagree Disagree Disagree Strongly 5. Skin looks firmer: Agree Strongly Agree Neither agree nor disagree Disagree Disagree Strongly 6. Skin feels elastic: Agree Strongly Agree Neither agree nor disagree Disagree Disagree Strongly 7. Redness looks reduced: Agree Strongly Agree Neither agree nor disagree Disagree Disagree Strongly
Time frame: 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
Time frame: 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
Time frame: Screening, Baseline, Day 28, Day 56, Day 84