Clinical trial NCT06638905: Efficacy and Safety of Skincare Serum and Cream for Anti-aging of Facial Skin
Official title: A Prospective, Open Label Clinical Study Evaluating the Efficacy and Safety of Skincare Serum and Cream for Anti-aging of Facial Skin
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: PHASE2
PHASE3
Conditions: Facial Wrinkles
Skin Aging
Keywords: Wrinkles
Face Wrinkles
Cosmetic
Crow's Feet
Lead sponsor: Goldman, Butterwick, Fitzpatrick and Groff
Sponsor class: OTHER
Collaborators: name: Babor Americas
First posted: 2024-10-15
Enrollment: 18
Sex: ALL
Minimum age (years): 18
Maximum age (years): 50
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: Subjects will be treated with a combination therapy of Babor Ultimate ECM Repair Serum and the Babor Cure Cream to their entire face.
Primary purpose: TREATMENT

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.

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):

  1. Class I-II of Wrinkling on the Fitzpatrick-Goldman Classification of Wrinkling and Degree of Elastosis Scale
  2. Score 1-6 of Degree of Elastosis on the Fitzpatrick-Goldman Classification of Wrinkling and Degree of Elastosis Scale
  3. Mild to Moderate on Redness/Erythema Grading Scale
  4. Mild to Moderate on Dryness/Scaling/Roughness Grading Scale
  5. 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.
* Subjects must be willing and able to understand and comply with the requirements of the study including prolonged sun exposure and apply the products as instructed, return for the required treatment period visits, comply with therapy prohibitions, and be able to complete the study
* For female subjects of childbearing potential, must be willing to use an acceptable form of birth control during the entire course of the study. All systemic birth control measures must be in consistent use for at least 30 days prior to study enrollment.

  1. A female is considered of childbearing potential unless she is postmenopausal, without a uterus and/or both ovaries, or has had a bilateral tubal ligation.
  2. Acceptable methods of birth control are: oral contraceptives, contraceptive patches/rings/implants, Implanon®, Depo-Provera®, double-barrier methods (e.g., condoms and spermicide), abstinence, and/or vasectomy of partner with a documented second acceptable method of birth control, should the subject become sexually active.

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.
* Subjects with a tattoo and/or scar in the treatment area that in the investigators opinion would interfere with study assessments.
* Subjects with history of or the presence of any skin condition/disease that might interfere with the diagnosis or evaluation of study parameters (i.e., atopic dermatitis, eczema, psoriasis, seborrheic dermatitis) at the discretion of the investigator.
* Inability to comply with all study protocol restrictions and visits.
* Current participation or participation within 30 days prior to the start of this study in a drug or other investigational research study.
* History of non-compliance with clinical research protocols.

Primary outcomes:
measure: Fitzpatrick- Goldman Classification of Wrinkling and Degree of Elastosis Scale
timeFrame: Screening, Day 60, Day 90
measure: Evaluating Investigator Expert Grading Scales
timeFrame: Screening, Day 30, Day 60, Day 90
measure: Evaluating Investigator Expert Grading Scales (part 2)
timeFrame: Screening, Day 30, Day 60, Day 90
Secondary outcomes:
measure: Evaluating Investigator Tolerability Assessment
timeFrame: Screening, Day 30, Day 60, Day 90
measure: Subject Self-Assessment Questionnaire (part 1)
timeFrame: Screening, Day 30, Day 60, Day 90
measure: Subject Self-Assessment Questionnaire (part 2)
timeFrame: Screening, Day 30, Day 60, Day 90
measure: Subject Self-Assessment Questionnaire (part 3)
timeFrame: Screening, Day 30, Day 60, Day 90
measure: Subject Self-Assessment Questionnaire (part 4)
timeFrame: Screening, Day 30, Day 60, Day 90
Other outcomes:
Locations:
Study officials:
References: