Compare the effectiveness of laser treatment using CE Ferulic versus vehicle pre/post laser.
Adult males and females aged 30-70 years (Fitzpatrick I-IV 30-65 years, Fitzpatrick V-VI 30-70 years)
Fitzpatrick skin types I-VI
Subjects in good general health based on investigator's judgment and medical history
Must be willing to give and sign an informed consent form and photographic release form
Energy-based device (i.e., radiofrequency device treatments, microfocused ultrasound device or other ultrasound-based device treatments, laser and light-based device treatments, microneedling) treatment in the treatment area in the last 6 months
Chemical peel or microdermabrasion of the face within 60 days prior to enrollment in the study
Dermal fillers, biostimulators, or neurotoxins treatments of the face during the 6-month period before the study period or planning to undergo during the study period
Surgery (i.e., face lift, eyebrow lift, neck lift or lower rhytidectomy, liposuction to the neck and/or submentum, etc.) during the 12-month period before study treatment
Parallel
CE Ferulic
DrugCE Ferulic serum regimen combined with laser treatment
Sham Comparator
DrugVehicle serum regimen combined with laser treatment
1927nm (Clear and Brilliant Perméa®)
Devicenon-ablative fractional diode laser
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
Overall Hyperpigmentation/ Discoloration
Score 0 thru 9 Score 0= No hyperpigmentation Score 9= Significant hyperpigmentation, numerous spots, uneven skin tone
Skin Tone Evenness
Score 0 thru 9 Score 0= Very even tone Score 9= Uneven, discolored appearance (brown and/or red colors)
Skin Elasticity
Score 0 thru 9 Score 0= Skin feels toned, dense Score 9= Skin feels pliable, thin and non-resilient
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
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
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
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
Click on the lead sponsor to view all of their trials.
Goldman, Butterwick, Fitzpatrick and Groff
Lead sponsor
L'Oreal
Collaborator
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