A Prospective, Open Label Clinical Study Evaluating the Efficacy and Safety of Skincare Serum and Cream for Anti-aging of Facial Skin
Overview
- Phase
- Phase 2
- Intervention
- Babor Ultimate ECM Repair Serum
- Conditions
- Facial Wrinkles
- Sponsor
- Goldman, Butterwick, Fitzpatrick and Groff
- Enrollment
- 18
- Primary Endpoint
- Fitzpatrick- Goldman Classification of Wrinkling and Degree of Elastosis Scale
- Status
- Not yet recruiting
- Last Updated
- last year
Overview
Brief Summary
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.
Detailed Description
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.
Investigators
Eligibility Criteria
Inclusion Criteria
- •Men and women between the ages of 18 and 50 years old (inclusive).
- •Subjects must be able and willing to provide written informed consent and photography release.
- •At the baseline evaluation, all subjects must exhibit mild to moderate skin aging, as defined below (Appendix A):
- •Class I-II of Wrinkling on the Fitzpatrick-Goldman Classification of Wrinkling and Degree of Elastosis Scale
- •Score 1-6 of Degree of Elastosis on the Fitzpatrick-Goldman Classification of Wrinkling and Degree of Elastosis Scale
- •Mild to Moderate on Redness/Erythema Grading Scale
- •Mild to Moderate on Dryness/Scaling/Roughness Grading Scale
- •Mild to Moderate on Luminosity Scale
- •Subject must be in good general health with no other skin disease, disease state or physical condition which would impair evaluation of the areas to be treated or which would increase the subject's health risk by study participation.
- •Subjects must have a willingness to minimize sun exposure, avoid direct sun exposure on the face, and avoid the use of tanning beds for the entire duration of the study. Must be willing to wear a hat and reapply sunscreen if sun exposure is unavoidable.
Exclusion Criteria
- •Subjects who are pregnant, planning pregnancy during the course of the study, or breastfeeding.
- •Subjects with an active bacterial, fungal, or viral infection in the treatment area
- •Subjects with a significant history or current evidence of a medical, psychological or other disorder that, in the investigator's opinion, would preclude enrollment into the study.
- •Subjects receiving any topical products containing tretinoins or derivatives, alpha-hydroxy acids, salicylic acid, and vitamins C or E (includes derivatives thereof) on the face within 14 days prior to or during the study period, other than the study products.
- •Subjects receiving a chemical peel, any systemic steroids, a non-ablative laser, ablative laser, microfocused ultrasound, light or radio frequency treatment, deep chemical peel, and/or has had a Dermabrasion on their face must have discontinued the drug/treatment and/or had the procedure at least 6 months prior to entering the study.
- •Subjects who have had a microdermabrasion (light or medium skin peel) treatment on their face within 30 days prior to and not willing to refrain from use for the duration of the study period.
- •Subjects with recently excessive exposure to sunlight or artificial UV light (e.g.: use of tanning beds/booths and/or sunbathing) or expectations of tanning during the time of the study or has used self-tanner within 7 days of study entry.
- •Subjects that has previously been treated with a systemic retinoid within the past 3 months (e.g., Accutane®, Roche Dermatologics).
- •Subjects with a history of keloids or hypertrophic scars.
- •Subjects with known allergies to any of the product ingredients.
Arms & Interventions
Babor Products
Enrolled subjects will all receive Babor Ultimate ECM Repair Serum and Babor Cure Cream to be applied to their entire face.
Intervention: Babor Ultimate ECM Repair Serum
Babor Products
Enrolled subjects will all receive Babor Ultimate ECM Repair Serum and Babor Cure Cream to be applied to their entire face.
Intervention: Babor Cure Cream
Outcomes
Primary Outcomes
Fitzpatrick- Goldman Classification of Wrinkling and Degree of Elastosis Scale
Time Frame: Screening, Day 60, Day 90
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
Evaluating Investigator Expert Grading Scales
Time Frame: Screening, Day 30, Day 60, Day 90
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
Evaluating Investigator Expert Grading Scales (part 2)
Time Frame: Screening, Day 30, Day 60, Day 90
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
Secondary Outcomes
- Evaluating Investigator Tolerability Assessment(Screening, Day 30, Day 60, Day 90)
- Subject Self-Assessment Questionnaire (part 1)(Screening, Day 30, Day 60, Day 90)
- Subject Self-Assessment Questionnaire (part 2)(Screening, Day 30, Day 60, Day 90)
- Subject Self-Assessment Questionnaire (part 3)(Screening, Day 30, Day 60, Day 90)
- Subject Self-Assessment Questionnaire (part 4)(Screening, Day 30, Day 60, Day 90)