Efficacy and Safety of Skincare Serum and Cream for Anti-aging of Facial Skin

Last updated: October 9, 2024
Sponsor: Goldman, Butterwick, Fitzpatrick and Groff
Overall Status: Active - Not Recruiting

Phase

2/3

Condition

Skin Aging

Treatment

Babor Ultimate ECM Repair Serum

Babor Cure Cream

Clinical Study ID

NCT06638905
Babor-2024
  • Ages 18-50
  • All Genders
  • Accepts Healthy Volunteers

Study 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.

Eligibility Criteria

Inclusion

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 andphotography 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 Wrinklingand Degree of Elastosis Scale

  2. Score 1-6 of Degree of Elastosis on the Fitzpatrick-Goldman Classification ofWrinkling 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 orphysical condition which would impair evaluation of the areas to be treated or whichwould increase the subject's health risk by study participation.

  • Subjects must have a willingness to minimize sun exposure, avoid direct sun exposureon 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 ofthe 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 acceptableform of birth control during the entire course of the study. All systemic birthcontrol measures must be in consistent use for at least 30 days prior to studyenrollment.

  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, contraceptivepatches/rings/implants, Implanon®, Depo-Provera®, double-barrier methods (e.g.,condoms and spermicide), abstinence, and/or vasectomy of partner with adocumented second acceptable method of birth control, should the subject becomesexually active.

Exclusion

Exclusion Criteria:

  • Subjects who are pregnant, planning pregnancy during the course of the study, orbreastfeeding.

  • Subjects with an active bacterial, fungal, or viral infection in the treatment area

  • Subjects with a significant history or current evidence of a medical, psychologicalor other disorder that, in the investigator's opinion, would preclude enrollmentinto the study.

  • Subjects receiving any topical products containing tretinoins or derivatives,alpha-hydroxy acids, salicylic acid, and vitamins C or E (includes derivativesthereof) on the face within 14 days prior to or during the study period, other thanthe study products.

  • Subjects receiving a chemical peel, any systemic steroids, a non-ablative laser,ablative laser, microfocused ultrasound, light or radio frequency treatment, deepchemical peel, and/or has had a Dermabrasion on their face must have discontinuedthe drug/treatment and/or had the procedure at least 6 months prior to entering thestudy.

  • Subjects who have had a microdermabrasion (light or medium skin peel) treatment ontheir face within 30 days prior to and not willing to refrain from use for theduration 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 thetime 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 3months (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 investigatorsopinion would interfere with study assessments.

  • Subjects with history of or the presence of any skin condition/disease that mightinterfere with the diagnosis or evaluation of study parameters (i.e., atopicdermatitis, eczema, psoriasis, seborrheic dermatitis) at the discretion of theinvestigator.

  • Inability to comply with all study protocol restrictions and visits.

  • Current participation or participation within 30 days prior to the start of thisstudy in a drug or other investigational research study.

  • History of non-compliance with clinical research protocols.

Study Design

Total Participants: 18
Treatment Group(s): 2
Primary Treatment: Babor Ultimate ECM Repair Serum
Phase: 2/3
Study Start date:
October 28, 2024
Estimated Completion Date:
May 05, 2025

Study 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.