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

ConditionsFacial Wrinkles Skin Aging

Trial statusNot yet recruiting

Trial phasePhase 2, Phase 3

Trial typeInterventional

Biological sexAll

Age18-50

SponsorGoldman, Butterwick, Fitzpatrick and Groff

About this trial

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

This trial accepts healthy volunteers

Qualifiers

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.

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

Disqualifiers

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.

Trial design

Design model

Single group

Treatments tested in this trial

Babor Ultimate ECM Repair Serum
Drug
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 Cure Cream
Drug
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.

Treatment groups

18 Participants

are divided into 1 treatment group

Group A: Babor ProductsExperimental treatment 2 interventions

Trial outcomes

Primary outcomes

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