The primary objective of this study is to assess the efficacy and safety of combination therapy of BABOR® Ultimate ECM Repair Serum and the BABOR® Cure Cream for the improvement of anti-aging through the use of investigator assessments, subject questionnaires/assessments, photography, skin imaging, and reported adverse reactions.
Enrolled subjects will use a skin care regimen cosisting of BABOR® Ultimate ECM Repair Serum, BABOR® Cure Cream gel, mineral sunscreen, and regeneration cleanser and regeneration toner. Subjects satisfying all inclusion and exclusion criteria will be enrolled in this trial. Prior to receiving any study treatment, mandatory photography using Canfield VISIA imaging and handheld 2D photography. Patients will return for follow-up assessments at Day 30, 60, and 90.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
18
The BABOR® Ultimate ECM Repair Serum contains Biogen plant extract, cotton thistle flower, and wakame extract. Babor products are encouraged to be used simultaneously mornings and/or evenings to reinforce the skin's protective barrier, promote vibrant skin, and restore skin elasticity and firmness.
Babor products are encouraged to be used simultaneously mornings and/or evenings to reinforce the skin's protective barrier, promote vibrant skin, and restore skin elasticity and firmness.
Fitzpatrick- Goldman Classification of Wrinkling and Degree of Elastosis Scale
Circle appropriate class: Class one: Mild Fine Wrinkles 1-2-3 Class two: Moderate Wrinkles 4-5-6 Class three: Severe Wrinkles 7-8-9
Time frame: Screening, Day 60, Day 90
Evaluating Investigator Expert Grading Scales
Redness/ Erythema: None (Score of 0) No erythema or redness of the treatment area Mild (Score of 1, 2 or 3) Slight, but definite redness of the treatment area Moderate (Score of 4, 5 or 6) Definite redness of the treatment area Severe (Score of 7, 8 or 9) Marked redness of the treatment area Dryness/ Scaling/Roughness: None (Score of 0) No dryness, roughness, or flaking/scaling of the treatment area Mild (Score of 1, 2 or 3) Slight, but definite roughness, some areas of light visible flaking/scaling of the treatment area Moderate (Score of 4, 5 or 6) Definite roughness and areas of visible flaking/scaling of the treatment area Severe (Score of 7, 8 or 9) Marked roughness and areas of visible flaking/scaling of the treatment area
Time frame: Screening, Day 30, Day 60, Day 90
Evaluating Investigator Expert Grading Scales (part 2)
Luminosity: None (Score of 0) Radiant, luminous or glowing appearance Mild (Score of 1, 2 or 3) Some areas of dullness or matte skin in the treatment area Moderate (Score of 4, 5 or 6) Several areas of dullness or matte skin in the treatment area Severe (Score of 7, 8 or 9) Dull/matte and/or sallow skin appearance
Time frame: Screening, Day 30, Day 60, Day 90
Evaluating Investigator Tolerability Assessment
Stinging/ Burning: None (Score of 0) No stinging/burning of the treatment area Mild (Score of 1, 2 or 3) Slight, but definite stinging/burning of the treatment area Moderate (Score of 4, 5 or 6) Definite stinging/burning of the treatment area Severe (Score of 7, 8 or 9) Marked stinging/burning of the treatment area Itching: None (Score of 0) No itching of the treatment area. Mild (Score of 1, 2 or 3) Slight, but definite itching of the treatment area. Moderate (Score of 4, 5 or 6) Definite itching of the treatment area that is distracting from daily activities. Severe (Score of 7, 8 or 9) Marked itching of the treatment area that wakes you up at night. Rash: None (Score of 0) No new rash over the treatment area. Mild (Score of 1, 2 or 3) New rash covering some of the treatment area. Moderate (Score of 4, 5 or 6) New rash covering much of the treatment area. Severe (Score of 7, 8 or 9) New rash covering the entirety of the treatment area.
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.
Time frame: Screening, Day 30, Day 60, Day 90
Subject Self-Assessment Questionnaire (part 1)
1. Skincare regimen helps reduce the wrinkles of my facial skin. Agree Strongly Agree Neither agree nor disagree Disagree Disagree Strongly 2. Skincare regimen helps reduce the dryness of my facial skin. Agree Strongly Agree Neither agree nor disagree Disagree Disagree Strongly 3. Cleanser/moisturizer regimen helps decrease the dullness of my facial skin. Agree Strongly Agree Neither agree nor disagree Disagree Disagree Strongly 4. Skincare regimen helps reduce the unevenness of my facial skin. Agree Strongly Agree Neither agree nor disagree Disagree Disagree Strongly 5. Skincare regimen leaves my facial skin radiant/brighter. Agree Strongly Agree Neither agree nor disagree Disagree Disagree Strongly
Time frame: Screening, Day 30, Day 60, Day 90
Subject Self-Assessment Questionnaire (part 2)
6\. Skincare regimen leaves my facial skin softer. Agree Strongly Agree Neither agree nor disagree Disagree Disagree Strongly 7. Skincare regimen leaves my facial skin smoother. Agree Strongly Agree Neither agree nor disagree Disagree Disagree Strongly 8. Skincare regimen is gentle. Agree Strongly Agree Neither agree nor disagree Disagree Disagree Strongly 9. Skincare regimen leaves my facial skin healthy looking. Agree Strongly Agree Neither agree nor disagree Disagree Disagree Strongly 10. Skincare regimen helps reduce the flakiness of my skin. Agree Strongly Agree Neither agree nor disagree Disagree Disagree Strongly
Time frame: Screening, Day 30, Day 60, Day 90
Subject Self-Assessment Questionnaire (part 3)
11\. I now understand the importance of a consistent skincare routine. Agree Strongly Agree Neither agree nor disagree Disagree Disagree Strongly 12. I feel more confident about the appearance of my facial skin. Agree Strongly Agree Neither agree nor disagree Disagree Disagree Strongly 13. Using this skincare regimen makes me optimistic about my appearance. Agree Strongly Agree Neither agree nor disagree Disagree Disagree Strongly 14. This skincare regimen was easy to follow. Agree Strongly Agree Neither agree nor disagree Disagree Disagree Strongly 15. It was easy to adhere to this skincare routine. Agree Strongly Agree Neither agree nor disagree Disagree Disagree Strongly
Time frame: Screening, Day 30, Day 60, Day 90
Subject Self-Assessment Questionnaire (part 4)
16\. Using these products did not irritate my skin. Agree Strongly Agree Neither agree nor disagree Disagree Disagree Strongly 17. The results I received made me want to continue this skincare routine. Agree Strongly Agree Neither agree nor disagree Disagree Disagree Strongly 18. I was able to easily commit to this routine due to its simplicity. Agree Strongly Agree Neither agree nor disagree Disagree Disagree Strongly 19. Please include further comments regarding your experience with these products. Agree Strongly Agree Neither agree nor disagree Disagree Disagree Strongly
Time frame: Screening, Day 30, Day 60, Day 90